Trial Outcomes & Findings for A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis (NCT NCT04673786)
NCT ID: NCT04673786
Last Updated: 2023-06-05
Results Overview
The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
509 participants
Primary outcome timeframe
From baseline to Week 12
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
CT-P43
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
Treatment Period II: All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
EU-Stelara
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
Treatment Period II: Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40).
|
Switched to CT-P43
Treatment Period I: Not applicable
Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|
|
Treatment Period I (Weeks 0 to 16)
STARTED
|
256
|
253
|
0
|
|
Treatment Period I (Weeks 0 to 16)
COMPLETED
|
253
|
249
|
0
|
|
Treatment Period I (Weeks 0 to 16)
NOT COMPLETED
|
3
|
4
|
0
|
|
Treatment Period II (Weeks 16 to 52)
STARTED
|
253
|
125
|
124
|
|
Treatment Period II (Weeks 16 to 52)
COMPLETED
|
239
|
122
|
122
|
|
Treatment Period II (Weeks 16 to 52)
NOT COMPLETED
|
14
|
3
|
2
|
Reasons for withdrawal
| Measure |
CT-P43
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
Treatment Period II: All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
EU-Stelara
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
Treatment Period II: Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40).
|
Switched to CT-P43
Treatment Period I: Not applicable
Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|
|
Treatment Period I (Weeks 0 to 16)
Withdrawal by Subject
|
3
|
3
|
0
|
|
Treatment Period I (Weeks 0 to 16)
Lost to Follow-up
|
0
|
1
|
0
|
|
Treatment Period II (Weeks 16 to 52)
Withdrawal by Subject
|
9
|
3
|
1
|
|
Treatment Period II (Weeks 16 to 52)
Lost to Follow-up
|
2
|
0
|
0
|
|
Treatment Period II (Weeks 16 to 52)
Death
|
1
|
0
|
0
|
|
Treatment Period II (Weeks 16 to 52)
Adverse Event
|
2
|
0
|
1
|
Baseline Characteristics
A Study to Compare the Efficacy and Safety of CT-P43 to Stelara in Patients With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
CT-P43
n=256 Participants
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
EU-Stelara
n=253 Participants
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Total
n=509 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.6 years
STANDARD_DEVIATION 13.00 • n=93 Participants
|
42.2 years
STANDARD_DEVIATION 12.64 • n=4 Participants
|
42.4 years
STANDARD_DEVIATION 12.81 • n=27 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
175 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=93 Participants
|
173 Participants
n=4 Participants
|
334 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
231 Participants
n=93 Participants
|
230 Participants
n=4 Participants
|
461 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Estonia
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
South Korea
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
189 Participants
n=93 Participants
|
188 Participants
n=4 Participants
|
377 Participants
n=27 Participants
|
|
Region of Enrollment
Ukraine
|
37 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 12Population: Modified ITT Set
The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Outcome measures
| Measure |
CT-P43
n=256 Participants
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
EU-Stelara
n=253 Participants
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Switched to CT-P43
Treatment Period I: Not applicable Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|
|
The Mean Percent Improvement From Baseline in PASI Score at Week 12
|
77.93 percentage of improvement in PASI score
Standard Error 1.771
|
75.89 percentage of improvement in PASI score
Standard Error 1.739
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Modified ITT Set (participants analysed at Week 12)
The Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Outcome measures
| Measure |
CT-P43
n=256 Participants
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
EU-Stelara
n=248 Participants
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Switched to CT-P43
Treatment Period I: Not applicable Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|
|
The PASI Scores at Week 12
|
2.98 score on a scale
Standard Deviation 3.412
|
3.44 score on a scale
Standard Deviation 4.362
|
—
|
SECONDARY outcome
Timeframe: Through Week 52Population: Modified ITT Set
The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score through Week 52. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Outcome measures
| Measure |
CT-P43
n=242 Participants
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
EU-Stelara
n=122 Participants
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Switched to CT-P43
n=123 Participants
Treatment Period I: Not applicable Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|
|
The Mean Percent Improvement From Baseline in PASI Score Through Week 52
|
93.79 percentage of improvement in PASI score
Standard Deviation 11.794
|
93.39 percentage of improvement in PASI score
Standard Deviation 14.947
|
91.58 percentage of improvement in PASI score
Standard Deviation 13.264
|
SECONDARY outcome
Timeframe: Week 12Population: Modified ITT Set
The number of participants achieving at least 50%/75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
Outcome measures
| Measure |
CT-P43
n=256 Participants
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
EU-Stelara
n=253 Participants
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Switched to CT-P43
Treatment Period I: Not applicable Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|
|
The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12
PASI 90
|
129 Participants
|
127 Participants
|
—
|
|
The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12
PASI 100
|
47 Participants
|
48 Participants
|
—
|
|
The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12
PASI 50
|
247 Participants
|
240 Participants
|
—
|
|
The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12
PASI 75
|
212 Participants
|
187 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Modified ITT Set
The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the erythema, average thickness, and scaling of all psoriatic lesions at a given time point. The sum of the 3 scales will be divided by 3 to obtain a final sPGA score.
Outcome measures
| Measure |
CT-P43
n=256 Participants
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
EU-Stelara
n=253 Participants
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Switched to CT-P43
Treatment Period I: Not applicable Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|
|
The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12
|
219 Participants
|
201 Participants
|
—
|
SECONDARY outcome
Timeframe: Through Week 52Population: Modified ITT set
This DLQI is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Total scores range from 0 to 30 (less to more impairment).
Outcome measures
| Measure |
CT-P43
n=242 Participants
Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
EU-Stelara
n=122 Participants
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Switched to CT-P43
n=123 Participants
Treatment Period I: Not applicable Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|
|
The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52
|
-10.5 score on a scale
Standard Deviation 7.24
|
-8.5 score on a scale
Standard Deviation 7.17
|
-9.2 score on a scale
Standard Deviation 6.93
|
Adverse Events
Treatment Period I: CT-P43
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Treatment Period I: EU-Stelara
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Treatment II: CT-P43 Maintenance
Serious events: 5 serious events
Other events: 35 other events
Deaths: 1 deaths
Treatment Period II: EU-Stelara Maintenance
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Treatment Period II: Switched to CT-P43
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Period I: CT-P43
n=256 participants at risk
Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Treatment Period I: EU-Stelara
n=253 participants at risk
Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Treatment II: CT-P43 Maintenance
n=253 participants at risk
All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
Treatment Period II: EU-Stelara Maintenance
n=125 participants at risk
Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40).
|
Treatment Period II: Switched to CT-P43
n=124 participants at risk
Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.39%
1/256 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Infections and infestations
COVID-19 pneumonia
|
0.78%
2/256 • Number of events 2 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.80%
1/125 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Psychiatric disorders
Bipolar disorder
|
0.39%
1/256 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Infections and infestations
COVID-19
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.80%
1/125 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tubular breast carcinoma
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.80%
1/125 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/124 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.81%
1/124 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/125 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.81%
1/124 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
Other adverse events
| Measure |
Treatment Period I: CT-P43
n=256 participants at risk
Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Treatment Period I: EU-Stelara
n=253 participants at risk
Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed \>100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
Treatment II: CT-P43 Maintenance
n=253 participants at risk
All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
Treatment Period II: EU-Stelara Maintenance
n=125 participants at risk
Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40).
|
Treatment Period II: Switched to CT-P43
n=124 participants at risk
Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40).
|
|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
4.3%
11/256 • Number of events 11 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
4.7%
12/253 • Number of events 12 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
5.1%
13/253 • Number of events 13 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
8.8%
11/125 • Number of events 11 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
5.6%
7/124 • Number of events 8 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
3/256 • Number of events 3 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
3.2%
8/253 • Number of events 8 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
4.0%
10/253 • Number of events 10 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
3.2%
4/125 • Number of events 4 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
5.6%
7/124 • Number of events 8 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
2.8%
7/253 • Number of events 7 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
3.2%
4/125 • Number of events 4 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
3.2%
4/124 • Number of events 4 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.40%
1/253 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.80%
1/125 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
3.2%
4/124 • Number of events 4 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
1.2%
3/253 • Number of events 3 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
2.4%
3/125 • Number of events 3 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
4.8%
6/124 • Number of events 6 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.79%
2/253 • Number of events 2 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
2.4%
3/125 • Number of events 3 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
3.2%
4/124 • Number of events 4 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/256 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.00%
0/253 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
1.6%
4/253 • Number of events 4 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
0.80%
1/125 • Number of events 1 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
3.2%
4/124 • Number of events 5 • Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place