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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Summary
EudraCT number	2014-003513-28
Trial protocol	DE CZ HU
Global end of trial date	24 Oct 2018

Results information
Results version number	v1(current)
This version publication date	08 Nov 2019
First version publication date	08 Nov 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

PS0005

ISRCTN number

US NCT number

NCT02326298

WHO universal trial number (UTN)

Sponsor organisation name

UCB Biopharma SPRL

Sponsor organisation address

Allée de la Recherche 60, Brussels, Belgium, B-1070

Public contact

Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com

Scientific contact

Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

29 Nov 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

24 Oct 2018

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the efficacy of certolizumab pegol (CZP) administered subcutaneously (sc) at the doses of CZP 400 mg every 2 weeks (Q2W) and CZP 200 mg Q2W after a loading dose of CZP 400 mg at Weeks 0, 2, and 4 in the treatment of moderate to severe chronic plaque psoriasis (PSO).

Protection of trial subjects

During the conduct of the study all participants were closely monitored.

Background therapy

Background therapy/concomitant medication as permitted in the protocol.

Evidence for comparator

Not applicable

Actual start date of recruitment

16 Dec 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Czech Republic: 24

Country: Number of subjects enrolled

Canada: 42

Country: Number of subjects enrolled

Germany: 77

Country: Number of subjects enrolled

Hungary: 13

Country: Number of subjects enrolled

United States: 78

Worldwide total number of subjects

234

EEA total number of subjects

114

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

221

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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.

Screening details

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.

Period 1 title

Initial Period (Week 0 to Week 16)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo Q2W

Arm description

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.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

PBO

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections every 2 Weeks (Q2W), administered at separate injection sites: lateral abdominal wall and upper outer thigh.

CZP 200 mg Q2W

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

CZP 400 mg Q2W

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Number of subjects in period 1	Placebo Q2W	CZP 200 mg Q2W	CZP 400 mg Q2W
Started	51	95	88
Completed Week 16	46	92	87
Finished Wk16 started Maintenance Period	46	92	85
Completed	46	92	85
Not completed	5	3	3
Consent withdrawn by subject	3	2	-
Adverse event after completing wk16	-	-	2
Adverse event, non-fatal	-	-	1
Lost to follow-up	1	1	-
Lack of efficacy	1	-	-

Period 2 title

Maintenance Period (Week 16 to Week 48)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Blinding implementation details

Participants who entered the escape arms of the study received open-label CZP 400 mg every two weeks.

Are arms mutually exclusive

Yes

Placebo/Placebo Q2W

Arm description

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).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

PBO

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections every 2 Weeks (Q2W), administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Placebo/CZP 200 mg Q2W

Arm description

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).

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Investigational medicinal product name

Placebo

Investigational medicinal product code

PBO

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections every 2 Weeks (Q2W), administered at separate injection sites: lateral abdominal wall and upper outer thigh.

CZP 200 mg Q2W/CZP 200 mg Q2W

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

CZP 400 mg Q2W/CZP 400 mg Q2W

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Placebo/Escape CZP 400 mg Q2W

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

PBO

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections every 2 Weeks (Q2W), administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

CZP 200 mg Q2W/Escape CZP 400 mg Q2W

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

CZP 400 mg Q2W/Escape CZP 400 mg Q2W

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Number of subjects in period 2	Placebo/Placebo Q2W	Placebo/CZP 200 mg Q2W	CZP 200 mg Q2W/CZP 200 mg Q2W	CZP 400 mg Q2W/CZP 400 mg Q2W	Placebo/Escape CZP 400 mg Q2W	CZP 200 mg Q2W/Escape CZP 400 mg Q2W	CZP 400 mg Q2W/Escape CZP 400 mg Q2W
Started	3	5	74	77	38	18	8
Completed Week 48	3	5	71	70	33	13	7
Finished Wk48 entered Open-label Period	3	5	69	70	33	13	7
Completed	3	5	69	70	33	13	7
Not completed	0	0	5	7	5	5	1
Patient did not achieve PASI50 response	-	-	1	2	-	4	-
Consent withdrawn by subject	-	-	1	3	1	1	1
No valid reason stated by patient	-	-	-	-	1	-	-
Adverse event, non-fatal	-	-	-	-	1	-	-
Pregnancy	-	-	-	1	-	-	-
Patient cannot attend visits	-	-	1	-	-	-	-
Did not achieve PASI50 after week 48	-	-	2	-	-	-	-
Lost to follow-up	-	-	-	1	2	-	-

Period 3 title

Open-label Period (Week 48 to Week 144)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Placebo/CZP 200 mg Q2W OLE

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

PBO

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections every 2 Weeks (Q2W), administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

CZP 200 mg Q2W/CZP 200 mg Q2W OLE

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

CZP 400 mg Q2W/CZP 200 mg Q2W OLE

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Certolizumab pegol

Investigational medicinal product code

CZP

Other name

Cimzia

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Subcutaneous injections: 200 mg every 2 Weeks (Q2W) or 400 mg Q2W, were administered at separate injection sites: lateral abdominal wall and upper outer thigh.

Number of subjects in period 3	Placebo/CZP 200 mg Q2W OLE	CZP 200 mg Q2W/CZP 200 mg Q2W OLE	CZP 400 mg Q2W/CZP 200 mg Q2W OLE	Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE
Started	3	74	70	53
Completed	3	54	51	44
Not completed	0	20	19	9
Adverse event, serious fatal	-	1	-	-
Consent withdrawn by subject	-	7	2	1
Adverse event, non-fatal	-	3	3	-
Protocol violation	-	-	-	1
Lost to follow-up	-	6	6	3
Lack of efficacy	-	1	1	-
Did not achieve PASI50	-	2	7	3
Protocol deviation	-	-	-	1

Baseline characteristics

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Reporting group title

Placebo Q2W

Reporting group description

Reporting group title

CZP 200 mg Q2W

Reporting group description

Reporting group title

CZP 400 mg Q2W

Reporting group description

Reporting group values	Placebo Q2W	CZP 200 mg Q2W	CZP 400 mg Q2W	Total
Number of subjects	51	95	88	234
Age categorical
Units: Subjects
<=18 years	0	0	0	0
Between 18 and 65 years	45	90	86	221
>=65 years	6	5	2	13
Age continuous
Units: Years
arithmetic mean (standard deviation)	47.9 ± 12.8	44.5 ± 13.1	43.6 ± 12.1	-
Gender categorical
Units: Subjects
Female	16	28	28	72
Male	35	67	60	162

Subject analysis set title

Placebo Q2W (RS)

Subject analysis set type

Full analysis

Subject analysis set description

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).

Subject analysis set title

CZP 200 mg Q2W (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

CZP 400 mg Q2W (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

CZP 200 mg Q2W (TCS)

Subject analysis set type

Safety analysis

Subject analysis set description

This arm consisted of all participants who received CZP 200 mg at any time during the study.

Subject analysis set title

CZP 400 mg Q2W (TCS)

Subject analysis set type

Safety analysis

Subject analysis set description

This arm consisted of all participants who received CZP 400 mg at any time during the study.

Subject analysis sets values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)	CZP 200 mg Q2W (TCS)	CZP 400 mg Q2W (TCS)
Number of subjects	51	95	88	188	167
Age categorical
Units: Subjects
<=18 years	0	0	0	0	0
Between 18 and 65 years	45	90	86	177	160
>=65 years	6	5	2	11	7
Age continuous
Units: Years
arithmetic mean (standard deviation)	47.9 ± 12.8	44.5 ± 13.1	43.6 ± 12.1	44.9 ± 12.9	44.8 ± 12.1
Gender categorical
Units: Subjects
Female	16	28	28	55	52
Male	35	67	60	133	115

End points

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Reporting group title

Placebo Q2W

Reporting group description

Reporting group title

CZP 200 mg Q2W

Reporting group description

Reporting group title

CZP 400 mg Q2W

Reporting group description

Reporting group title

Placebo/Placebo Q2W

Reporting group description

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).

Reporting group title

Placebo/CZP 200 mg Q2W

Reporting group description

Reporting group title

CZP 200 mg Q2W/CZP 200 mg Q2W

Reporting group description

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.

Reporting group title

CZP 400 mg Q2W/CZP 400 mg Q2W

Reporting group description

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.

Reporting group title

Placebo/Escape CZP 400 mg Q2W

Reporting group description

Reporting group title

CZP 200 mg Q2W/Escape CZP 400 mg Q2W

Reporting group description

Reporting group title

CZP 400 mg Q2W/Escape CZP 400 mg Q2W

Reporting group description

Reporting group title

Placebo/CZP 200 mg Q2W OLE

Reporting group description

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.

Reporting group title

CZP 200 mg Q2W/CZP 200 mg Q2W OLE

Reporting group description

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.

Reporting group title

CZP 400 mg Q2W/CZP 200 mg Q2W OLE

Reporting group description

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.

Reporting group title

Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE

Reporting group description

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.

Subject analysis set title

Placebo Q2W (RS)

Subject analysis set type

Full analysis

Subject analysis set description

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).

Subject analysis set title

CZP 200 mg Q2W (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

CZP 400 mg Q2W (RS)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

CZP 200 mg Q2W (TCS)

Subject analysis set type

Safety analysis

Subject analysis set description

This arm consisted of all participants who received CZP 200 mg at any time during the study.

Subject analysis set title

CZP 400 mg Q2W (TCS)

Subject analysis set type

Safety analysis

Subject analysis set description

This arm consisted of all participants who received CZP 400 mg at any time during the study.

Primary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

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End point title

Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

End point description

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.

End point type

Primary

End point timeframe

At Week 16

End point values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	51	95	88
Units: percentage of participants
number (not applicable)	6.5	66.5	75.8

Statistical analysis 1

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 200 mg Q2W (RS)

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[1]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

28.962

Confidence interval

level

97.5%

sides

2-sided

lower limit

6.968

upper limit

120.371

Notes
[1] - The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) PBO.

Statistical analysis 2

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 400 mg Q2W (RS)

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[2]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

45.66

Confidence interval

level

97.5%

sides

2-sided

lower limit

10.657

upper limit

195.634

Notes
[2] - The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.

Statistical analysis 3

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 200 mg Q2W (RS)

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

47.92

upper limit

72.17

Statistical analysis 4

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 400 mg Q2W (RS)

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

69.3

Confidence interval

level

95%

sides

2-sided

lower limit

57.65

upper limit

80.99

Primary: 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

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End point title

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

End point description

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.

End point type

Primary

End point timeframe

At Week 16

End point values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	51	95	88
Units: percentage of participants
number (not applicable)	4.2	47.0	57.9

Statistical analysis 1

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 200 mg Q2W (RS)

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[3]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

20.116

Confidence interval

level

97.5%

sides

2-sided

lower limit

3.699

upper limit

109.399

Notes
[3] - The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.

Statistical analysis 2

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 400 mg Q2W (RS)

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[4]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

31.143

Confidence interval

level

97.5%

sides

2-sided

lower limit

5.687

upper limit

170.548

Notes
[4] - The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.

Statistical analysis 3

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 200 mg Q2W (RS)

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

42.8

Confidence interval

level

95%

sides

2-sided

lower limit

30.7

upper limit

54.86

Statistical analysis 4

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 400 mg Q2W (RS)

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

53.6

Confidence interval

level

95%

sides

2-sided

lower limit

41.33

upper limit

65.94

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16

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End point title

Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16

End point description

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.

End point type

Secondary

End point timeframe

At Week 16

End point values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	51	95	88
Units: percentage of participants
number (not applicable)	0.4	35.8	43.6

Statistical analysis 1

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 200 mg Q2W (RS)

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[5]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

36.668

Confidence interval

level

97.5%

sides

2-sided

lower limit

5.717

upper limit

235.193

Notes
[5] - The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.

Statistical analysis 2

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 400 mg Q2W (RS)

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[6]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

50.606

Confidence interval

level

97.5%

sides

2-sided

lower limit

7.88

upper limit

324.988

Notes
[6] - The p-value for this analysis as used in the fixed sequence testing procedure was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.

Statistical analysis 3

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 200 mg Q2W (RS)

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

35.4

Confidence interval

level

95%

sides

2-sided

lower limit

20.85

upper limit

49.87

Statistical analysis 4

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 400 mg Q2W (RS)

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

43.1

Confidence interval

level

95%

sides

2-sided

lower limit

27.56

upper limit

58.71

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

End point description

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).

End point type

Secondary

End point timeframe

At Week 16

End point values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	51	95	88
Units: Scores on a scale
least squares mean (standard error)	-3.3 ± 0.80	-9.3 ± 0.58	-10.2 ± 0.60

Statistical analysis 1

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 200 mg Q2W (RS)

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[7]

Method

ANCOVA

Parameter type

Adjusted Mean Treatment Differences

Point estimate

-6

Confidence interval

level

97.5%

sides

2-sided

lower limit

-8.18

upper limit

-3.81

Notes
[7] - P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.

Statistical analysis 2

Statistical analysis description

The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.

Comparison groups

Placebo Q2W (RS) v CZP 400 mg Q2W (RS)

Number of subjects included in analysis

139

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[8]

Method

ANCOVA

Parameter type

Ajusted Mean Treatment Differences

Point estimate

-6.84

Confidence interval

level

97.5%

sides

2-sided

lower limit

-9.05

upper limit

-4.62

Notes
[8] - P-value obtained for each treatment group comparison tested at a significance level of 0.025 in the fixed sequence testing procedure.

Secondary: 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

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End point title

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

End point description

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.

End point type

Secondary

End point timeframe

At Week 48

End point values	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	95	88
Units: percentage of participants
number (confidence interval 95%)	52.7 (41.99 to 63.32)	69.5 (59.24 to 79.77)

No statistical analyses for this end point

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48

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End point title

Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48

End point description

End point type

Secondary

End point timeframe

At Week 48

End point values	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	95	88
Units: percentage of participants
number (confidence interval 95%)	67.2 (57.09 to 77.39)	87.1 (79.81 to 94.45)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).

Adverse event reporting additional description

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.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

18.1

Reporting group title

CZP 400 mg Q2W (TCS)

Reporting group description

This arm consisted of all participants who received CZP 400 mg at any time during the study.

Reporting group title

CZP 200 mg Q2W (TCS)

Reporting group description

This arm consisted of all participants who received CZP 200 mg at any time during the study.

Serious adverse events	CZP 400 mg Q2W (TCS)	CZP 200 mg Q2W (TCS)
Total subjects affected by serious adverse events
subjects affected / exposed	19 / 167 (11.38%)	14 / 188 (7.45%)
number of deaths (all causes)	1	1
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian adenoma
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Gastric bypass
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Strangulated hernia
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injection site reaction
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Anaphylactoid reaction
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	2 / 167 (1.20%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hallucination
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Concussion
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hand fracture
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple injuries
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Rib fracture
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Lymphadenitis
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Splenic haematoma
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Blepharochalasis
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Gastrointestinal necrosis
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cirrhosis alcoholic
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	1 / 167 (0.60%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyoderma gangrenosum
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Periarthritis
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rotator cuff syndrome
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Muscle atrophy
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Anal abscess
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection bacterial
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Borrelia infection
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infected bite
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Erysipelas
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Type 2 diabetes mellitus
subjects affected / exposed	0 / 167 (0.00%)	1 / 188 (0.53%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gout
subjects affected / exposed	1 / 167 (0.60%)	0 / 188 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	CZP 400 mg Q2W (TCS)	CZP 200 mg Q2W (TCS)
Total subjects affected by non serious adverse events
subjects affected / exposed	85 / 167 (50.90%)	95 / 188 (50.53%)
Nervous system disorders
Headache
subjects affected / exposed	14 / 167 (8.38%)	9 / 188 (4.79%)
occurrences all number	41	18
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	5 / 167 (2.99%)	9 / 188 (4.79%)
occurrences all number	5	9
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	4 / 167 (2.40%)	14 / 188 (7.45%)
occurrences all number	5	16
Back pain
subjects affected / exposed	11 / 167 (6.59%)	12 / 188 (6.38%)
occurrences all number	12	13
Infections and infestations
Nasopharyngitis
subjects affected / exposed	51 / 167 (30.54%)	54 / 188 (28.72%)
occurrences all number	95	86
Upper respiratory tract infection
subjects affected / exposed	26 / 167 (15.57%)	21 / 188 (11.17%)
occurrences all number	42	28

More information

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Were there any global substantial amendments to the protocol? Yes

24 Nov 2015

The Global Protocol Amendment 1 included the following changes: -CIMPASI-1 (name of the PS0005 protocol) was added. -Updated study contact information and serious adverse event (SAE) reporting contact information. -Added the secondary efficacy variable: at least 90% reduction from Baseline in PASI (PASI90). -Removed the other efficacy variables: absolute PASI score and absolute body surface area (BSA) affected by PSO. -Corrected: the Subject Questionnaire for Tuberculosis (TB) was removed as a safety variable. -Clarified the responsibilities of the unblinded and blinded study personnel. -Provided additional details regarding breaking the treatment blind in an emergency situation. -Revised Exclusion Criteria number (#) 21 to add secukinumab and require a 24-week washout period. -Allowed flexibility of self-administration of certolizumab pegol (CZP) during the Open-label Treatment Period. -Corrected: subject treatment assignment was stratified by site.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/29660421

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Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

Primary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

Primary: 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

Primary: 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

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: 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

Secondary: 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

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

Primary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

Primary: 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

Primary: 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

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI90) response at Week 16

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) at Week 16

Secondary: 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

Secondary: 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

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48

Secondary: Proportion of subjects who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 48

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Study Followed by a Dose-Blind Period and Open-Label Follow-Up to Evaluate the Efficacy and Safety of Certolizumab Pegol in Subjects with Moderate to Severe Chronic Plaque Psoriasis