Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010) (NCT NCT01722331)

NCT ID: NCT01722331

Last Updated: 2022-03-23

Results Overview

The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

772 participants

Primary outcome timeframe

Week 12 (or end of trial if prior to Week 12)

Results posted on

2022-03-23

Participant Flow

The tables below present the Participant Flow for the Base Study only (Weeks 0 to 64: Part 1 for 12 weeks, Part 2 for 16 weeks, and Part 3 for 36 weeks).

Participant milestones

Participant milestones
Measure
Tildrakizumab 200 mg (Parts 1, 2 & 3)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).
Tildrakizumab 100 mg (Parts 1, 2 & 3)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).
Tildrakizumab 100 mg (Parts 1 & 2)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2).
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2). Tildrakizumab 200 mg administered SC once a week at Weeks 28, 40, 52, and 64 (Part 3).
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1).
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1). Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Matching placebo administered SC once a week at Weeks 0 and 4. Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
Part 1
STARTED
308
249
41
19
9
72
74
Part 1
COMPLETED
298
249
32
19
0
72
74
Part 1
NOT COMPLETED
10
0
9
0
9
0
0
Part 2
STARTED
298
249
31
19
0
72
74
Part 2
COMPLETED
279
249
0
19
0
62
67
Part 2
NOT COMPLETED
19
0
31
0
0
10
7
Part 3
STARTED
279
249
0
19
0
62
67
Part 3
COMPLETED
264
232
0
18
0
59
65
Part 3
NOT COMPLETED
15
17
0
1
0
3
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Tildrakizumab 200 mg (Parts 1, 2 & 3)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).
Tildrakizumab 100 mg (Parts 1, 2 & 3)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).
Tildrakizumab 100 mg (Parts 1 & 2)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2).
Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2). Tildrakizumab 200 mg administered SC once a week at Weeks 28, 40, 52, and 64 (Part 3).
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1).
Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3)
Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1). Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3)
Matching placebo administered SC once a week at Weeks 0 and 4. Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
Part 1
Adverse Event
5
0
0
0
0
0
0
Part 1
Lack of Efficacy
0
0
1
0
2
0
0
Part 1
Lost to Follow-up
1
0
2
0
1
0
0
Part 1
Physician Decision
0
0
3
0
1
0
0
Part 1
Pregnancy
1
0
0
0
0
0
0
Part 1
Progressive Disease
0
0
0
0
1
0
0
Part 1
Protocol Violation
1
0
0
0
1
0
0
Part 1
Withdrawal by Subject
2
0
3
0
3
0
0
Part 2
Adverse Event
3
0
0
0
0
1
0
Part 2
Lack of Efficacy
3
0
11
0
0
3
3
Part 2
Lost to Follow-up
0
0
3
0
0
1
1
Part 2
Non-Compliance with Study Drug
1
0
1
0
0
0
0
Part 2
Physician Decision
0
0
2
0
0
0
0
Part 2
Pregnancy
0
0
0
0
0
1
0
Part 2
Progressive Disease
0
0
1
0
0
0
0
Part 2
Protocol Violation
1
0
0
0
0
0
0
Part 2
Withdrawal by Subject
5
0
3
0
0
2
2
Part 2
Other Protocol Specified Criteria
6
0
10
0
0
2
1
Part 3
Adverse Event
2
2
0
1
0
0
0
Part 3
Death
1
0
0
0
0
0
0
Part 3
Lack of Efficacy
1
0
0
0
0
0
0
Part 3
Lost to Follow-up
3
4
0
0
0
1
0
Part 3
Non-Compliance with Study Drug
0
1
0
0
0
0
0
Part 3
Physician Decision
1
1
0
0
0
0
1
Part 3
Protocol Violation
2
1
0
0
0
0
0
Part 3
Withdrawal by Subject
4
7
0
0
0
2
1
Part 3
Other Protocol Specified Criteria
1
1
0
0
0
0
0

Baseline Characteristics

Analysis population includes participants with baseline PGA data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=155 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Total
n=772 Participants
Total of all reporting groups
Age, Continuous
46.9 Years
STANDARD_DEVIATION 13.16 • n=308 Participants
46.4 Years
STANDARD_DEVIATION 13.09 • n=309 Participants
47.9 Years
STANDARD_DEVIATION 13.55 • n=155 Participants
46.9 Years
STANDARD_DEVIATION 13.21 • n=772 Participants
Sex: Female, Male
Female
82 Participants
n=308 Participants
102 Participants
n=309 Participants
55 Participants
n=155 Participants
239 Participants
n=772 Participants
Sex: Female, Male
Male
226 Participants
n=308 Participants
207 Participants
n=309 Participants
100 Participants
n=155 Participants
533 Participants
n=772 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
37 Participants
n=308 Participants
34 Participants
n=309 Participants
19 Participants
n=155 Participants
90 Participants
n=772 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
271 Participants
n=308 Participants
275 Participants
n=309 Participants
135 Participants
n=155 Participants
681 Participants
n=772 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=308 Participants
0 Participants
n=309 Participants
1 Participants
n=155 Participants
1 Participants
n=772 Participants
Physician's Global Assessment (PGA) score
<3
0 Participants
n=308 Participants • Analysis population includes participants with baseline PGA data.
1 Participants
n=309 Participants • Analysis population includes participants with baseline PGA data.
0 Participants
n=154 Participants • Analysis population includes participants with baseline PGA data.
1 Participants
n=771 Participants • Analysis population includes participants with baseline PGA data.
Physician's Global Assessment (PGA) score
3
202 Participants
n=308 Participants • Analysis population includes participants with baseline PGA data.
206 Participants
n=309 Participants • Analysis population includes participants with baseline PGA data.
111 Participants
n=154 Participants • Analysis population includes participants with baseline PGA data.
519 Participants
n=771 Participants • Analysis population includes participants with baseline PGA data.
Physician's Global Assessment (PGA) score
4
95 Participants
n=308 Participants • Analysis population includes participants with baseline PGA data.
95 Participants
n=309 Participants • Analysis population includes participants with baseline PGA data.
41 Participants
n=154 Participants • Analysis population includes participants with baseline PGA data.
231 Participants
n=771 Participants • Analysis population includes participants with baseline PGA data.
Physician's Global Assessment (PGA) score
5
11 Participants
n=308 Participants • Analysis population includes participants with baseline PGA data.
7 Participants
n=309 Participants • Analysis population includes participants with baseline PGA data.
2 Participants
n=154 Participants • Analysis population includes participants with baseline PGA data.
20 Participants
n=771 Participants • Analysis population includes participants with baseline PGA data.
Body weight
<=90 kg
182 Participants
n=308 Participants
183 Participants
n=309 Participants
93 Participants
n=155 Participants
458 Participants
n=772 Participants
Body weight
>90 kg
126 Participants
n=308 Participants
126 Participants
n=309 Participants
62 Participants
n=155 Participants
314 Participants
n=772 Participants
Prior exposure to biologics therapy for psoriasis
Yes
71 Participants
n=308 Participants
71 Participants
n=309 Participants
35 Participants
n=155 Participants
177 Participants
n=772 Participants
Prior exposure to biologics therapy for psoriasis
No
237 Participants
n=308 Participants
238 Participants
n=309 Participants
120 Participants
n=155 Participants
595 Participants
n=772 Participants

PRIMARY outcome

Timeframe: Week 12 (or end of trial if prior to Week 12)

Population: Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.

The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)
62.3 Percentage of Participants
63.8 Percentage of Participants
5.8 Percentage of Participants

PRIMARY outcome

Timeframe: Baseline and Week 12 (or end of trial if prior to Week 12)

Population: Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.

The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study)
59.1 Percentage of Participants
57.9 Percentage of Participants
7.1 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.

An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)
130 Participants
146 Participants
74 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.

An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)
5 Participants
0 Participants
1 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.

A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)
2 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Week 12 (or end of trial if prior to Week 12)

Population: Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.

The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Percentage of Participants With PASI-90 Response At Week 12
35.4 Percentage of participants
34.6 Percentage of participants
2.6 Percentage of participants

SECONDARY outcome

Timeframe: Week 12 (or end of trial if prior to Week 12)

Population: Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.

The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Percentage of Participants With PASI-100 Response at Week 12
14.0 Percentage of participants
13.9 Percentage of participants
1.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have baseline DLQI measurement

The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Baseline Dermatology Life Quality Index (DLQI) Score
13.2 Score on a scale
Standard Deviation 6.87
13.9 Score on a scale
Standard Deviation 6.68
13.2 Score on a scale
Standard Deviation 7.25

SECONDARY outcome

Timeframe: Baseline and Week 12 (or end of trial if prior to Week 12)

Population: Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have at least one DLQI measurement (post-baseline or baseline).

The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=308 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=309 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=154 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Change From Baseline in the Participant DLQI Score at Week 12
-10.0 Score on a scale
Interval -10.7 to -9.4
-9.8 Score on a scale
Interval -10.4 to -9.1
-2.3 Score on a scale
Interval -3.1 to -1.5

SECONDARY outcome

Timeframe: Week 12 (or end of trial if prior to Week 12)

Population: Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have a DLQI measurement at Week 12 (or end of trial if prior to Week 12).

The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.

Outcome measures

Outcome measures
Measure
Tildrakizumab 200 mg (Part 1)
n=299 Participants
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Tildrakizumab 100 mg (Part 1)
n=304 Participants
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Placebo (Part 1)
n=150 Participants
Matching placebo administered SC once a week at Weeks 0 and 4.
Percentage of Participants With DLQI Score of 0 or 1 at Week 12
44.2 Percentage of participants
41.5 Percentage of participants
5.3 Percentage of participants

Adverse Events

Tildrakizumab 200 mg (Part 1)

Serious events: 8 serious events
Other events: 35 other events
Deaths: 0 deaths

Tildrakizumab 100 mg (Part 1)

Serious events: 5 serious events
Other events: 36 other events
Deaths: 0 deaths

Placebo (Part 1)

Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths

Tildrakizumab 200 mg (Part 2)

Serious events: 8 serious events
Other events: 38 other events
Deaths: 0 deaths

Tildrakizumab 100 mg (Part 2)

Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths

Tildrakizumab 200 mg (Part 3)

Serious events: 21 serious events
Other events: 86 other events
Deaths: 0 deaths

Tildrakizumab 100 mg (Part 3)

Serious events: 14 serious events
Other events: 78 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Tildrakizumab 200 mg (Part 1)
n=308 participants at risk
Tildrakizumab 200 mg administered once a week at Weeks 0 and 4.
Tildrakizumab 100 mg (Part 1)
n=309 participants at risk
Tildrakizumab 100 mg administered once a week at Weeks 0 and 4.
Placebo (Part 1)
n=154 participants at risk
Placebo administered once a week at Weeks 0 and 4.
Tildrakizumab 200 mg (Part 2)
n=370 participants at risk
Tildrakizumab 200 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 200 mg).
Tildrakizumab 100 mg (Part 2)
n=374 participants at risk
Tildrakizumab 100 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 100 mg). Includes 1 participant who did not enter Part 2, but received an unscheduled dose at Week 12.
Tildrakizumab 200 mg (Part 3)
n=360 participants at risk
Participants received tildrakizumab 200 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
Tildrakizumab 100 mg (Part 3)
n=316 participants at risk
Participants received tildrakizumab 100 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
Cardiac disorders
Acute myocardial infarction
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/309 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Cardiac disorders
Coronary artery disease
0.32%
1/308 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Cardiac disorders
Tachycardia
0.32%
1/308 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Gastrointestinal disorders
Pancreatitis acute
0.32%
1/308 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Gastrointestinal disorders
Salivary gland enlargement
0.32%
1/308 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Infections and infestations
Cellulitis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/309 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.56%
2/360 • Number of events 2 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Infections and infestations
Epiglottitis
0.32%
1/308 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Nervous system disorders
Presyncope
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.65%
1/154 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
0.32%
1/308 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Psychiatric disorders
Suicide attempt
0.32%
1/308 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/309 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.32%
1/308 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/309 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/309 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Gastrointestinal disorders
Constipation
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/374 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Gastrointestinal disorders
Diverticulum
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/374 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Gastrointestinal disorders
Pancreatitis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/374 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Infections and infestations
Bone tuberculosis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Infections and infestations
Diverticulitis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/374 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Infections and infestations
Gastroenteritis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/374 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/374 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.63%
2/316 • Number of events 3 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/374 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.56%
2/360 • Number of events 2 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.63%
2/316 • Number of events 2 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Nervous system disorders
Lacunar infarction
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Vascular disorders
Deep vein thrombosis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.27%
1/370 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Blood and lymphatic system disorders
Anaemia
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Cardiac disorders
Angina pectoris
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Eye disorders
Cataract
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Eye disorders
Macular fibrosis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Gastrointestinal disorders
Food poisoning
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
General disorders
Non-cardiac chest pain
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.56%
2/360 • Number of events 2 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Hepatobiliary disorders
Cholecystitis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Hepatobiliary disorders
Cholelithiasis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Immune system disorders
Anaphylactic reaction
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Infections and infestations
Gastroenteritis salmonella
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Infections and infestations
Sinusitis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Injury, poisoning and procedural complications
Lower limb fracture
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign biliary neoplasm
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Nervous system disorders
Cerebellar infarction
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Nervous system disorders
Sciatica
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Nervous system disorders
Transient ischaemic attack
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Reproductive system and breast disorders
Uterine haemorrhage
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/360 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.32%
1/316 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Vascular disorders
Aneurysm
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/309 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/154 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/370 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/374 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.28%
1/360 • Number of events 1 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.00%
0/316 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.

Other adverse events

Other adverse events
Measure
Tildrakizumab 200 mg (Part 1)
n=308 participants at risk
Tildrakizumab 200 mg administered once a week at Weeks 0 and 4.
Tildrakizumab 100 mg (Part 1)
n=309 participants at risk
Tildrakizumab 100 mg administered once a week at Weeks 0 and 4.
Placebo (Part 1)
n=154 participants at risk
Placebo administered once a week at Weeks 0 and 4.
Tildrakizumab 200 mg (Part 2)
n=370 participants at risk
Tildrakizumab 200 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 200 mg).
Tildrakizumab 100 mg (Part 2)
n=374 participants at risk
Tildrakizumab 100 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 100 mg). Includes 1 participant who did not enter Part 2, but received an unscheduled dose at Week 12.
Tildrakizumab 200 mg (Part 3)
n=360 participants at risk
Participants received tildrakizumab 200 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
Tildrakizumab 100 mg (Part 3)
n=316 participants at risk
Participants received tildrakizumab 100 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
Infections and infestations
Nasopharyngitis
6.5%
20/308 • Number of events 20 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
7.8%
24/309 • Number of events 26 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
5.2%
8/154 • Number of events 8 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
4.6%
17/370 • Number of events 18 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
6.4%
24/374 • Number of events 24 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
12.2%
44/360 • Number of events 55 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
15.2%
48/316 • Number of events 66 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/308 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.65%
2/309 • Number of events 2 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
5.2%
8/154 • Number of events 8 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.81%
3/370 • Number of events 4 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
0.53%
2/374 • Number of events 2 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
2.5%
9/360 • Number of events 9 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
2.8%
9/316 • Number of events 9 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
Infections and infestations
Upper respiratory tract infection
4.9%
15/308 • Number of events 15 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
3.2%
10/309 • Number of events 10 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
5.8%
9/154 • Number of events 10 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
5.4%
20/370 • Number of events 21 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
4.3%
16/374 • Number of events 17 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
10.3%
37/360 • Number of events 43 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
8.2%
26/316 • Number of events 32 • Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.

Additional Information

Head-Clinical Development

Sun Pharma Advanced Research Company Limited

Phone: 912266455645

Results disclosure agreements

  • Principal investigator is a sponsor employee The investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
  • Publication restrictions are in place

Restriction type: OTHER