Trial Outcomes & Findings for A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003) (NCT NCT01225731)

Last Updated: 2019-02-05

Results Overview

The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as \>=75% improvement in PASI score when compared to the baseline score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

355 participants

Primary outcome timeframe

Week 16

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug.
Part 1 STARTED	42	92	89	86	46	0	0	0	0	0	0	0	0
Part 1 COMPLETED	40	87	88	84	40	0	0	0	0	0	0	0	0
Part 1 NOT COMPLETED	2	5	1	2	6	0	0	0	0	0	0	0	0
Part 2 STARTED	0	0	0	0	0	13	94	153	79	0	0	0	0
Part 2 COMPLETED	0	0	0	0	0	10	86	128	68	0	0	0	0
Part 2 NOT COMPLETED	0	0	0	0	0	3	8	25	11	0	0	0	0
Part 3 STARTED	0	0	0	0	0	0	0	0	0	10	86	126	67
Part 3 COMPLETED	0	0	0	0	0	0	0	0	0	10	80	116	60
Part 3 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	6	10	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug.
Part 1 Did not meet eligibility criteria	1	0	0	0	1	0	0	0	0	0	0	0
Part 1 Adverse Event	1	2	1	1	1	0	0	0	0	0	0	0
Part 1 Withdrawal by Subject	0	3	0	0	4	0	0	0	0	0	0	0
Part 1 Protocol Violation	0	0	0	1	0	0	0	0	0	0	0	0
Part 2 Protocol Violation	0	0	0	0	0	1	0	0	1	0	0	0
Part 2 Adverse Event	0	0	0	0	0	0	4	4	2	0	0	0
Part 2 Lack of Efficacy	0	0	0	0	0	1	0	12	3	0	0	0
Part 2 Pregnancy	0	0	0	0	0	0	1	0	1	0	0	0
Part 2 Lost to Follow-up	0	0	0	0	0	0	0	3	1	0	0	0
Part 2 Physician Decision	0	0	0	0	0	0	0	2	2	0	0	0
Part 2 Withdrawal by Subject	0	0	0	0	0	1	3	4	1	0	0	0
Part 3 Adverse Event	0	0	0	0	0	0	0	0	0	1	1	0
Part 3 Lost to Follow-up	0	0	0	0	0	0	0	0	0	1	2	1
Part 3 Physician Decision	0	0	0	0	0	0	0	0	0	0	1	2
Part 3 Withdrawal by Subject	0	0	0	0	0	0	0	0	0	4	6	4

Baseline Characteristics

A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=92 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=46 Participants Participants receive placebo, SC, at Weeks 0 and 4	Total n=355 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 12.9 • n=93 Participants	46.3 years STANDARD_DEVIATION 13.7 • n=4 Participants	45.5 years STANDARD_DEVIATION 12.8 • n=27 Participants	43.2 years STANDARD_DEVIATION 12.6 • n=483 Participants	45.9 years STANDARD_DEVIATION 11.7 • n=36 Participants	44.9 years STANDARD_DEVIATION 12.9 • n=10 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	32 Participants n=4 Participants	13 Participants n=27 Participants	21 Participants n=483 Participants	8 Participants n=36 Participants	85 Participants n=10 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	60 Participants n=4 Participants	76 Participants n=27 Participants	65 Participants n=483 Participants	38 Participants n=36 Participants	270 Participants n=10 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The Full Analysis Set (FAS), all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=90 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16	33.33 Percentage of participants	64.44 Percentage of participants	66.29 Percentage of participants	74.42 Percentage of participants	4.44 Percentage of participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 72 weeks

Population: All participants receiving at least one dose of study drug.

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=91 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg n=13 Participants Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg n=94 Participants Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg n=153 Participants Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg n=79 Participants Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up n=10 Participants Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up n=86 Participants Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up n=126 Participants Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up n=67 Participants Participants are followed for up to 20 weeks after the last dose of study drug
Number of Participants Experiencing Adverse Events	30 Participants	56 Participants	58 Participants	54 Participants	31 Participants	7 Participants	60 Participants	105 Participants	52 Participants	3 Participants	32 Participants	53 Participants	28 Participants

PRIMARY outcome

Timeframe: Up to 52 weeks

Population: All particpants receiving at least one dose of study drug during the treatment period.

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=91 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg n=13 Participants Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg n=94 Participants Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg n=153 Participants Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg n=79 Participants Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Number of Particpants Discontinuing Study Treatment Due to Adverse Events	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	5 Participants	5 Participants	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12

Population: The FAS, all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=90 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Percentage of Participants With a PASI 75 Response at Week 12	23.81 Percentage of participants	58.89 Percentage of participants	60.67 Percentage of participants	72.09 Percentage of participants	4.44 Percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The Full Analysis Set (FAS), all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement. The last non-missing post-baseline PGA value was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.

The PGA is used to determine the overall severity of a subject's psoriasis lesions at a given time point. Overall lesions will be graded for induration, 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 . 2 =Mild, majority of lesions have individual scores that average 2. 3= Modreate, 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	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=90 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Percentage of Participants With Physician's Global Assessment (PGA) of "Cleared" or "Minimal" at Week 16	33.33 Percentage of participants	57.78 Percentage of participants	61.80 Percentage of participants	74.42 Percentage of participants	2.22 Percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The FAS, all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement, and data for this endpoint.

The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 90 response was defined as \>=90 % improvement in PASI score when compared to the baseline score.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=40 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=87 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=88 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=84 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=41 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Percentage of Participants With PASI 90 Response at Week 16	12.50 Percentage of participants	25.29 Percentage of participants	38.64 Percentage of participants	52.38 Percentage of participants	2.44 Percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The FAS, all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement, and data fior this endpoint

The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 100 response was defined as 100 % improvement in PASI score when compared to the baseline score.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=40 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=87 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=88 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=84 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=41 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Percentage of Participants With PASI 100 Response at Week 16	5.0 Percentage of participants	9.20 Percentage of participants	14.77 Percentage of participants	16.67 Percentage of participants	0.00 Percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 16 Weeks

Population: The FAS, all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement. and data for the specific Week.

The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease).PASI 75 response was defined as \>=75% improvement in PASI score when compared to the baseline score at Week 2, 4, 6, 8, 12, or 16.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=90 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
PASI 75 Response Rate by Time Week 2 (n=42, 89, 89, 85, 45)	0.00 Percentage of participants	1.12 Percentage of participants	1.12 Percentage of participants	0.00 Percentage of participants	0.00 Percentage of participants	—	—	—	—	—	—	—	—
PASI 75 Response Rate by Time Week 4 (n=42, 89, 89, 85, 45)	0.00 Percentage of participants	11.24 Percentage of participants	11.24 Percentage of participants	3.53 Percentage of participants	0.00 Percentage of participants	—	—	—	—	—	—	—	—
PASI 75 Response Rate by Time Week 6 (n=40, 86, 88, 84,44)	12.50 Percentage of participants	20.93 Percentage of participants	25.00 Percentage of participants	30.95 Percentage of participants	2.27 Percentage of participants	—	—	—	—	—	—	—	—
PASI 75 Response Rate by Time Week 8 (n=40, 88, 87, 83, 43)	12.50 Percentage of participants	35.23 Percentage of participants	47.13 Percentage of participants	61.45 Percentage of participants	4.65 Percentage of participants	—	—	—	—	—	—	—	—
PASI 75 Response Rate by Time Week 12 (n=40, 87, 88, 83, 42)	25.00 Percentage of participants	59.77 Percentage of participants	61.36 Percentage of participants	73.49 Percentage of participants	4.76 Percentage of participants	—	—	—	—	—	—	—	—
PASI 75 Response Rate by Time Week 16 (n=40, 87, 88, 84, 41)	35.00 Percentage of participants	65.52 Percentage of participants	67.05 Percentage of participants	76.19 Percentage of participants	4.88 Percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Weeks 12 and 16

Population: The FAS, all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement, and data for Week 12 and Week 16.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=90 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Mean Change From Baseline in PASI Score at Weeks 12 and 16 Week 12	-10.2 Score on a scale Interval -12.5 to -7.9	-14.4 Score on a scale Interval -16.0 to -12.9	-14.1 Score on a scale Interval -15.7 to -12.5	-14.9 Score on a scale Interval -16.5 to -13.3	-2.2 Score on a scale Interval -4.4 to 0.0	—	—	—	—	—	—	—	—
Mean Change From Baseline in PASI Score at Weeks 12 and 16 Week 16	-10.0 Score on a scale Interval -12.3 to -7.6	-14.6 Score on a scale Interval -16.2 to -13.0	-14.9 Score on a scale Interval -16.5 to -13.3	-15.6 Score on a scale Interval -17.2 to -14.0	-2.4 Score on a scale Interval -4.7 to -0.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 50 response was defined as \>=50 % improvement in PASI score when compared to the baseline score.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=42 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=90 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Percentage of Participants With PASI 50 Response at Week 16	57.14 Percentage of participants	82.22 Percentage of participants	82.02 Percentage of participants	91.86 Percentage of participants	8.89 Percentage of participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The FAS, all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement, and had data for this endpoint.

The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=40 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=87 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=88 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=83 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=42 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16	-4.9 Score on a scale Interval -7.0 to -2.8	-9.2 Score on a scale Interval -10.6 to -7.7	-8.5 Score on a scale Interval -9.9 to -7.1	-8.8 Score on a scale Interval -10.3 to -7.4	1.0 Score on a scale Interval -1.1 to 3.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The FAS, all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement, and data for this endpoint, excluding all participants on the placebo arm.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=40 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=87 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=88 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=83 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16	32.5 Percentage of participants	57.47 Percentage of participants	52.27 Percentage of participants	57.83 Percentage of participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 16

Population: The FAS, all randomized participants who received \>=1 dose of study drug and had a baseline and \>=1 post-treatment efficacy measurement, and had data for this endpoint.

Outcome measures

Outcome measures
Measure	Part 1: Tildrakizumab 5 mg n=40 Participants Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=87 Participants Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=88 Participants Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=83 Participants Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=42 Participants Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 25 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 100 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug	Part 3: Tildrakizumab 200 mg Follow-up Participants are followed for up to 20 weeks after the last dose of study drug
Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16	52.50 Percentage of participants	70.11 Percentage of participants	64.77 Percentage of participants	73.49 Percentage of participants	19.05 Percentage of participants	—	—	—	—	—	—	—	—

Adverse Events

Part 1: Tildrakizumab 5 mg

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Part 1: Tildrakizumab 25 mg

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Part 1: Tildrakizumab 100 mg

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Part 1: Tildrakizumab 200 mg

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Part 1: Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Part 2: Tildrakizumab 5 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 2: Tildrakizumab 25 mg

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

Part 2: Tildrakizumab 100 mg

Serious events: 6 serious events

Other events: 64 other events

Deaths: 0 deaths

Part 2: Tildrakizumab 200 mg

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Part 3: Tildrakizumab 5 mg Follow-up

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 3: Tildrakizumab 25 mg Follow-up

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Part 3: Tildrakizumab 100 mg Follow-up

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Part 3: Tildrakizumab 200 mg Follow-up

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo Follow-up

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Tildrakizumab 5 mg n=42 participants at risk Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=91 participants at risk Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 participants at risk Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 participants at risk Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 participants at risk Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg n=13 participants at risk Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg n=94 participants at risk Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg n=153 participants at risk Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg n=79 participants at risk Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up n=12 participants at risk Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 25 mg Follow-up n=87 participants at risk Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 100 mg Follow-up n=137 participants at risk Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 200 mg Follow-up n=75 participants at risk Participants are followed for up to 20 weeks after the last dose of study drug.	Placebo Follow-up n=2 participants at risk Participants who received placebo in Part 1 and did not receive additional therapy.
Infections and infestations Soft tissue infection	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/75 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Nervous system disorders Thrombotic cerebral infarction	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
General disorders Death	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/89 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Arthritis bacterial	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/91 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.2% 1/86 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Vascular disorders Lymphoedema	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.2% 1/86 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Appendicitis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Cellulitis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/79 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Epiglottitis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Sinusitis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Injury, poisoning and procedural complications Contusion	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/79 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Injury, poisoning and procedural complications Tendonn rupture	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/79 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/79 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/75 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Nervous system disorders Ischaemic stroke	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
General disorders Hernia	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/87 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	50.0% 1/2 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.

Other adverse events

Other adverse events
Measure	Part 1: Tildrakizumab 5 mg n=42 participants at risk Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4	Part 1: Tildrakizumab 25 mg n=91 participants at risk Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 100 mg n=89 participants at risk Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4	Part 1: Tildrakizumab 200 mg n=86 participants at risk Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4	Part 1: Placebo n=45 participants at risk Participants receive placebo, SC, at Weeks 0 and 4	Part 2: Tildrakizumab 5 mg n=13 participants at risk Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 25 mg n=94 participants at risk Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 100 mg n=153 participants at risk Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks	Part 2: Tildrakizumab 200 mg n=79 participants at risk Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks	Part 3: Tildrakizumab 5 mg Follow-up n=12 participants at risk Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 25 mg Follow-up n=87 participants at risk Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 100 mg Follow-up n=137 participants at risk Participants are followed for up to 20 weeks after the last dose of study drug.	Part 3: Tildrakizumab 200 mg Follow-up n=75 participants at risk Participants are followed for up to 20 weeks after the last dose of study drug.	Placebo Follow-up n=2 participants at risk Participants who received placebo in Part 1 and did not receive additional therapy.
Infections and infestations Diverticulitis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Ear infection	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/91 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.2% 1/86 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/87 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Congenital, familial and genetic disorders Odontogenic cyst	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/79 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	8.3% 1/12 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Gastrointestinal disorders Diarrhoea	2.4% 1/42 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	5.5% 5/91 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	6.7% 6/89 • Number of events 7 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.5% 3/86 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	6.7% 3/45 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.3% 5/153 • Number of events 6 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.8% 3/79 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/87 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/75 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Gastrointestinal disorders Gastric ulcer	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/89 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.2% 3/94 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 2/153 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Gastrointestinal disorders Hiatus hernia	2.4% 1/42 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
General disorders Pyrexia	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/91 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.4% 3/89 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.2% 1/45 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.0% 3/153 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.5% 2/79 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	50.0% 1/2 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Acute tonsilitis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Bronchiitis	7.1% 3/42 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.3% 3/91 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/89 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	4.4% 2/45 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.0% 3/153 • Number of events 6 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.5% 2/79 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.3% 2/87 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.7% 2/75 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Folliculitis	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/91 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/89 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.3% 2/86 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.2% 1/45 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.65% 1/153 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/79 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.7% 2/75 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Gastroenteritis	4.8% 2/42 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.4% 3/89 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.5% 3/86 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.2% 1/45 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	5.3% 5/94 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.6% 4/153 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	6.3% 5/79 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/87 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/75 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Nasopharyngitis	16.7% 7/42 • Number of events 9 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	13.2% 12/91 • Number of events 14 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	14.6% 13/89 • Number of events 15 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	12.8% 11/86 • Number of events 11 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	20.0% 9/45 • Number of events 10 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	23.1% 3/13 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	25.5% 24/94 • Number of events 32 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	22.2% 34/153 • Number of events 42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	16.5% 13/79 • Number of events 21 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	6.9% 6/87 • Number of events 9 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	8.8% 12/137 • Number of events 13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	6.7% 5/75 • Number of events 6 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Rhinitis	2.4% 1/42 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/91 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.2% 2/89 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.3% 2/86 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 2/153 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.8% 3/79 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/87 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.7% 2/75 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Infections and infestations Upper Respiratory Tract Infection	4.8% 2/42 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.4% 3/89 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.3% 2/86 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.2% 3/94 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.9% 6/153 • Number of events 7 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	5.1% 4/79 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.3% 2/87 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.2% 3/137 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	4.0% 3/75 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Injury, poisoning and procedural complications Contusion	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.2% 2/91 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.5% 2/79 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Injury, poisoning and procedural complications Injury	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Investigations Blood pressure systolic increased	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Investigations Hypercholesterolaemia	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.2% 1/86 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/42 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	4.4% 4/91 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.4% 3/89 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.5% 3/86 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	4.3% 4/94 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	5.2% 8/153 • Number of events 8 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.8% 3/79 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	8.3% 1/12 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.4% 3/87 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.6% 5/137 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/75 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Nervous system disorders Headache	7.1% 3/42 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	5.5% 5/91 • Number of events 8 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	6.7% 6/89 • Number of events 8 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	8.1% 7/86 • Number of events 8 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	8.9% 4/45 • Number of events 6 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.2% 3/94 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	8.5% 13/153 • Number of events 17 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.8% 3/79 • Number of events 6 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/87 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.6% 5/137 • Number of events 7 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.7% 2/75 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Psychiatric disorders Sleep disorder	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	7.7% 1/13 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/153 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 3/42 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.2% 2/91 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.2% 2/89 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.2% 1/86 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	4.4% 2/45 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	2.1% 2/94 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.3% 5/153 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/87 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/42 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/91 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/86 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/45 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/94 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 2/153 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/79 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	8.3% 1/12 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/137 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/75 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/42 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	4.4% 4/91 • Number of events 5 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/89 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	4.7% 4/86 • Number of events 6 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	8.9% 4/45 • Number of events 4 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/13 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.1% 1/94 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 2/153 • Number of events 2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	3.8% 3/79 • Number of events 3 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/12 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/87 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.73% 1/137 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	1.3% 1/75 • Number of events 1 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.	0.00% 0/2 • Up to 72 weeks All participants who received at least one dose of tildrakizumab or placebo.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme

Phone: 1-800-672-6372

Email: [email protected]

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 in any media that report any results of the trial. The Sponsor shall have the right to review and comment on the data analysis and presentation.
Publication restrictions are in place

Restriction type: OTHER