Trial Outcomes & Findings for An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) (NCT NCT02326298)
NCT ID: NCT02326298
Last Updated: 2019-11-07
Results Overview
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
234 participants
Primary outcome timeframe
At Week 16
Results posted on
2019-11-07
Participant Flow
The study started to enroll participants in December 2014 and concluded in October 2018 from multiple sites in Europe and North America. 234 participants were included in the Randomized Set (RS) shown in the Participant Flow.
The study included a 5 Week Screening Period, a Double-blind Initial Treatment Period up to Week 16, a Dose-blind Maintenance Treatment Period up to Week 48, an Open-label Treatment Period up to Week 144 and a Post Study Safety Follow-up Period up to Week 152. Participant Flow refers to the Randomized Set, Open Label Set and Maintenance Set.
Participant milestones
| Measure |
Placebo Q2W
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
|
CZP 200 mg Q2W
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
|
CZP 400 mg Q2W
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
|
Placebo/Placebo Q2W
This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive Placebo in the Maintenance Period (Week 16 to Week 48).
|
Placebo/CZP 200 mg Q2W
This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI50 response at Week 16 but not a PASI75 response and received CZP 400 mg at Weeks 16, 18, and 20 (loading doses) followed by CZP 200 mg Q2W (starting at Week 22).
|
CZP 200 mg Q2W/CZP 200 mg Q2W
This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 200 mg Q2W.
|
CZP 400 mg Q2W/CZP 400 mg Q2W
This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W.
|
Placebo/Escape CZP 400 mg Q2W
This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
|
CZP 200 mg Q2W/Escape CZP 400 mg Q2W
This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received CZP unblinded 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
|
CZP 400 mg Q2W/Escape CZP 400 mg Q2W
This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
|
Placebo/CZP 200 mg Q2W OLE
This arm consisted of participants who received dose-blind Placebo during the Maintenance Period, who achieved a PASI50 response at Week 48 and entered the OLE Period receiving CZP 200 mg Q2W.
|
CZP 200 mg Q2W/CZP 200 mg Q2W OLE
This arm consisted of participants who received blinded CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE on the CZP 200mg Q2W dose.
|
CZP 400 mg Q2W/CZP 200 mg Q2W OLE
This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48, and entered OLE on the CZP 200mg Q2W dose.
|
Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE
This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg Q2W dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Initial Period (Week 0 to Week 16)
STARTED
|
51
|
95
|
88
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
Completed Week 16
|
46
|
92
|
87
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
Finished Wk16 Started Maintenance Period
|
46
|
92
|
85
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
COMPLETED
|
46
|
92
|
85
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
NOT COMPLETED
|
5
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
STARTED
|
0
|
0
|
0
|
3
|
5
|
74
|
77
|
38
|
18
|
8
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Completed Week 48
|
0
|
0
|
0
|
3
|
5
|
71
|
70
|
33
|
13
|
7
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Finished Wk48 Entered Open-label Period
|
0
|
0
|
0
|
3
|
5
|
69
|
70
|
33
|
13
|
7
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
COMPLETED
|
0
|
0
|
0
|
3
|
5
|
69
|
70
|
33
|
13
|
7
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
5
|
7
|
5
|
5
|
1
|
0
|
0
|
0
|
0
|
|
Open-label Period (Week 48 to Week 144)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
74
|
70
|
53
|
|
Open-label Period (Week 48 to Week 144)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
54
|
51
|
44
|
|
Open-label Period (Week 48 to Week 144)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
19
|
9
|
Reasons for withdrawal
| Measure |
Placebo Q2W
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
|
CZP 200 mg Q2W
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
|
CZP 400 mg Q2W
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
|
Placebo/Placebo Q2W
This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI75 response at Week 16 and continued to receive Placebo in the Maintenance Period (Week 16 to Week 48).
|
Placebo/CZP 200 mg Q2W
This arm consisted of participants initially randomized in the Placebo arm, who achieved a PASI50 response at Week 16 but not a PASI75 response and received CZP 400 mg at Weeks 16, 18, and 20 (loading doses) followed by CZP 200 mg Q2W (starting at Week 22).
|
CZP 200 mg Q2W/CZP 200 mg Q2W
This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 200 mg Q2W.
|
CZP 400 mg Q2W/CZP 400 mg Q2W
This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who achieved a PASI50 response at Week 16 and continued to receive CZP 400 mg Q2W.
|
Placebo/Escape CZP 400 mg Q2W
This arm consisted of participants initially randomized in the Placebo arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
|
CZP 200 mg Q2W/Escape CZP 400 mg Q2W
This arm consisted of participants initially randomized in the CZP 200 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received CZP unblinded 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
|
CZP 400 mg Q2W/Escape CZP 400 mg Q2W
This arm consisted of participants initially randomized in the CZP 400 mg Q2W arm, who did not achieve a PASI50 response at Week 16 escaped from the blinded treatment and received unblinded CZP 400 mg Q2W, for 16 weeks. Participants who did not achieve PASI50 after 16 weeks of unblinded treatment were withdrawn from the study.
|
Placebo/CZP 200 mg Q2W OLE
This arm consisted of participants who received dose-blind Placebo during the Maintenance Period, who achieved a PASI50 response at Week 48 and entered the OLE Period receiving CZP 200 mg Q2W.
|
CZP 200 mg Q2W/CZP 200 mg Q2W OLE
This arm consisted of participants who received blinded CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE on the CZP 200mg Q2W dose.
|
CZP 400 mg Q2W/CZP 200 mg Q2W OLE
This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48, and entered OLE on the CZP 200mg Q2W dose.
|
Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE
This arm consisted of participants who received open-label CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg Q2W dose.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Initial Period (Week 0 to Week 16)
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
Lost to Follow-up
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
Withdrawal by Subject
|
3
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Initial Period (Week 0 to Week 16)
Adverse event after completing wk16
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Patient did not achieve PASI50 response
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Patient cannot attend visits
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
No valid reason stated by patient
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Maintenance Period (Week 16 to Week 48)
Did not achieve PASI50 after week 48
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Open-label Period (Week 48 to Week 144)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Open-label Period (Week 48 to Week 144)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
0
|
|
Open-label Period (Week 48 to Week 144)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
|
Open-label Period (Week 48 to Week 144)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Open-label Period (Week 48 to Week 144)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
2
|
1
|
|
Open-label Period (Week 48 to Week 144)
Did not achieve PASI50
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
7
|
3
|
|
Open-label Period (Week 48 to Week 144)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
6
|
3
|
Baseline Characteristics
An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO)
Baseline characteristics by cohort
| Measure |
Placebo Q2W
n=51 Participants
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
|
CZP 200 mg Q2W
n=95 Participants
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
|
CZP 400 mg Q2W
n=88 Participants
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
|
Total Title
n=234 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
221 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Continuous
|
47.9 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
44.5 Years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
43.6 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
44.9 Years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Week 16Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Placebo Q2W (RS)
n=51 Participants
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants formed the Randomized Set (RS).
|
CZP 200 mg Q2W (RS)
n=95 Participants
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
Participants formed the RS.
|
CZP 400 mg Q2W (RS)
n=88 Participants
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
Participants formed the RS.
|
|---|---|---|---|
|
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
|
6.5 percentage of participants
|
66.5 percentage of participants
|
75.8 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 16Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Outcome measures
| Measure |
Placebo Q2W (RS)
n=51 Participants
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants formed the Randomized Set (RS).
|
CZP 200 mg Q2W (RS)
n=95 Participants
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
Participants formed the RS.
|
CZP 400 mg Q2W (RS)
n=88 Participants
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
Participants formed the RS.
|
|---|---|---|---|
|
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16
|
4.2 percentage of participants
|
47.0 percentage of participants
|
57.9 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Placebo Q2W (RS)
n=51 Participants
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants formed the Randomized Set (RS).
|
CZP 200 mg Q2W (RS)
n=95 Participants
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
Participants formed the RS.
|
CZP 400 mg Q2W (RS)
n=88 Participants
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
Participants formed the RS.
|
|---|---|---|---|
|
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16
|
0.4 percentage of participants
|
35.8 percentage of participants
|
43.6 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 16Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.
The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than of equal to (\>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=\<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).
Outcome measures
| Measure |
Placebo Q2W (RS)
n=51 Participants
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants formed the Randomized Set (RS).
|
CZP 200 mg Q2W (RS)
n=95 Participants
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
Participants formed the RS.
|
CZP 400 mg Q2W (RS)
n=88 Participants
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
Participants formed the RS.
|
|---|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
|
-3.3 Scores on a scale
Standard Error 0.80
|
-9.3 Scores on a scale
Standard Error 0.58
|
-10.2 Scores on a scale
Standard Error 0.60
|
SECONDARY outcome
Timeframe: At Week 48Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.
Outcome measures
| Measure |
Placebo Q2W (RS)
n=95 Participants
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants formed the Randomized Set (RS).
|
CZP 200 mg Q2W (RS)
n=88 Participants
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
Participants formed the RS.
|
CZP 400 mg Q2W (RS)
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
Participants formed the RS.
|
|---|---|---|---|
|
Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48
|
52.7 percentage of participants
Interval 41.99 to 63.32
|
69.5 percentage of participants
Interval 59.24 to 79.77
|
—
|
SECONDARY outcome
Timeframe: At Week 48Population: The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Outcome measures
| Measure |
Placebo Q2W (RS)
n=95 Participants
Placebo sc injection Q2W.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22.
* PASI75 responders at Week 16 continued to receive Placebo.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants formed the Randomized Set (RS).
|
CZP 200 mg Q2W (RS)
n=88 Participants
CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W.
Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
Participants formed the RS.
|
CZP 400 mg Q2W (RS)
CZP 400 mg Q2W through Week 14.
Treatment received from Week 16 - 48 was based on initial treatment and response to treatment:
* PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W.
* PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study.
* PASI50 non-responders at Week 32 or a later time point were withdrawn from the study.
Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
Participants formed the RS.
|
|---|---|---|---|
|
Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48
|
67.2 percentage of participants
Interval 57.09 to 77.39
|
87.1 percentage of participants
Interval 79.81 to 94.45
|
—
|
Adverse Events
CZP 200 mg Q2W (TCS)
Serious events: 14 serious events
Other events: 95 other events
Deaths: 1 deaths
CZP 400 mg Q2W (TCS)
Serious events: 19 serious events
Other events: 85 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
CZP 200 mg Q2W (TCS)
n=188 participants at risk
This arm consisted of all participants who received CZP 200 mg at any time during the study.
|
CZP 400 mg Q2W (TCS)
n=167 participants at risk
This arm consisted of all participants who received CZP 400 mg at any time during the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Cardiac disorders
Atrial fibrillation
|
0.53%
1/188 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Eye disorders
Blepharochalasis
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
General disorders
Strangulated hernia
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
General disorders
Injection site reaction
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Immune system disorders
Anaphylactoid reaction
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Infections and infestations
Borrelia infection
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Infections and infestations
Infected bite
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Infections and infestations
Pneumonia
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Psychiatric disorders
Depression
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
1.2%
2/167 • Number of events 2 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Psychiatric disorders
Hallucination
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/188 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.60%
1/167 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Surgical and medical procedures
Gastric bypass
|
0.53%
1/188 • Number of events 1 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
0.00%
0/167 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
Other adverse events
| Measure |
CZP 200 mg Q2W (TCS)
n=188 participants at risk
This arm consisted of all participants who received CZP 200 mg at any time during the study.
|
CZP 400 mg Q2W (TCS)
n=167 participants at risk
This arm consisted of all participants who received CZP 400 mg at any time during the study.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
28.7%
54/188 • Number of events 86 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
30.5%
51/167 • Number of events 95 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.2%
21/188 • Number of events 28 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
15.6%
26/167 • Number of events 42 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
14/188 • Number of events 16 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
2.4%
4/167 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
12/188 • Number of events 13 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
6.6%
11/167 • Number of events 12 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Nervous system disorders
Headache
|
4.8%
9/188 • Number of events 18 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
8.4%
14/167 • Number of events 41 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
4.8%
9/188 • Number of events 9 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
3.0%
5/167 • Number of events 5 • Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60