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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	2014-003486-14
Trial protocol	DK AT
Global end of trial date	12 Sep 2018

Results information
Results version number	v1(current)
This version publication date	04 Oct 2019
First version publication date	04 Oct 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

PS0002

ISRCTN number

US NCT number

NCT02326272

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

02 Oct 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

12 Sep 2018

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the efficacy of Certolizumab Pegol (CZP) administered subcutaneous (sc) at the doses of CZP 400 mg every two 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 was permitted as defined in the study protocol.

Evidence for comparator

Not applicable.

Actual start date of recruitment

15 Dec 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 7

Country: Number of subjects enrolled

Canada: 60

Country: Number of subjects enrolled

Poland: 63

Country: Number of subjects enrolled

United States: 97

Worldwide total number of subjects

227

EEA total number of subjects

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)

206

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study started to enroll patients in December 2014 and concluded in September 2018 from multiple sites in Europe and North America. 227 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 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 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 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	49	91	87
Completed Week 16	45	84	83
Finished Wk16 entered Maintenance Period	45	84	81
Completed	45	84	81
Not completed	4	7	6
Consent withdrawn by subject	3	2	1
Adverse event, non-fatal	-	3	1
Lost to follow-up after completing wk16	-	-	1
Missed two doses	-	-	1
Lost to follow-up	1	2	-
Consent withdrawn after completing wk16	-	-	1
Moved from the study area	-	-	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 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

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 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 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

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 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 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 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 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 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 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	6	5	76	69	34	8	12
Completed Week 48	5	3	64	61	27	3	10
Finished Wk48 entered Open-label Period	5	3	63	60	27	3	10
Completed	5	3	63	60	27	3	10
Not completed	1	2	13	9	7	5	2
Adverse event after completing wk48	-	-	1	-	-	-	-
Consent withdrawn by subject	1	-	3	1	1	-	1
Subject moved out of state	-	-	-	-	1	-	-
Adverse event, non-fatal	-	2	3	4	2	1	-
Did not achieve PASI50 after wk48	-	-	-	1	-	-	-
Pregnancy	-	-	-	1	-	-	-
Non-compliance	-	-	-	-	-	1	-
Lost to follow-up	-	-	2	-	2	-	-
Lack of efficacy	-	-	2	1	-	1	1
Did not achieve PASI50	-	-	2	1	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

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 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 Q2W, 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 CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE.

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 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 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 OLE

Arm description

This arm consisted of participants who received blinded 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 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.

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 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	CZP 400 mg Q2W/CZP 400 mg Q2W OLE	Escape CZP 400 mg Q2W/CZP 400 mg Q2W OLE
Started	5	66	59	1	40
Completed	2	51	48	1	31
Not completed	3	15	11	0	9
Adverse event, serious fatal	-	-	1	-	-
Consent withdrawn by subject	-	4	-	-	2
Adverse event, non-fatal	1	8	3	-	1
Loss of efficacy	-	1	-	-	-
Pregnancy	-	-	1	-	-
Lost to follow-up	1	-	2	-	3
Lack of efficacy	1	-	1	-	-
Protocol deviation	-	1	-	-	-
Did not achieve PASI50	-	1	3	-	3

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	49	91	87	227
Age categorical
Units: Subjects
<=18 years	0	0	0	0
Between 18 and 65 years	46	84	76	206
>=65 years	3	7	11	21
Age continuous
Units: years
arithmetic mean (standard deviation)	43.3 ( 14.5 )	46.7 ( 13.3 )	46.4 ( 13.5 )	-
Gender categorical
Units: Subjects
Male	26	58	43	127
Female	23	33	44	100

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	49	91	87	170	149
Age categorical
Units: Subjects
<=18 years	0	0	0	0	0
Between 18 and 65 years	46	84	76	155	132
>=65 years	3	7	11	15	17
Age continuous
Units: years
arithmetic mean (standard deviation)	43.3 ( 14.5 )	46.7 ( 13.3 )	46.4 ( 13.5 )	45.7 ( 13.6 )	46.3 ( 13.7 )
Gender categorical
Units: Subjects
Male	26	58	43	100	76
Female	23	33	44	70	73

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 CZP 200mg Q2W in the Maintenance Period, who achieved a PASI50 response at Week 48 and entered OLE.

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

CZP 400 mg Q2W/CZP 400 mg Q2W OLE

Reporting group description

This arm consisted of participants who received blinded CZP 400mg Q2W in the Maintenance Period and entered OLE on the CZP 400mg 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.

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 participants who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

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End point title

Proportion of participants 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

Week 16

End point values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	49	91	87
Units: percentage of participants
number (not applicable)	11.6	81.4	82.6

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

140

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[1]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

33.405

Confidence interval

level

97.5%

sides

2-sided

lower limit

9.965

upper limit

111.983

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) placebo (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 200 mg Q2W (RS)

Number of subjects included in analysis

140

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

69.7

Confidence interval

level

95%

sides

2-sided

lower limit

57.12

upper limit

82.36

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 400 mg Q2W (RS)

Number of subjects included in analysis

136

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[2]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

36.212

Confidence interval

level

97.5%

sides

2-sided

lower limit

10.686

upper limit

122.713

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 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

136

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

58.47

upper limit

83.43

Primary: Proportion of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (with at least 2-category improvement) response at Week 16

Top of page

End point title

Proportion of participants 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

Week 16

End point values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	49	91	87
Units: percentage of participants
number (not applicable)	2.0	66.8	71.6

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

140

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[3]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

106.225

Confidence interval

level

97.5%

sides

2-sided

lower limit

9.572

upper limit

1178.843

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 200 mg Q2W (RS)

Number of subjects included in analysis

140

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

64.8

Confidence interval

level

95%

sides

2-sided

lower limit

52.16

upper limit

77.46

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 400 mg Q2W (RS)

Number of subjects included in analysis

136

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[4]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

133.163

Confidence interval

level

97.5%

sides

2-sided

lower limit

11.904

upper limit

1489.578

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 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

136

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

69.6

Confidence interval

level

95%

sides

2-sided

lower limit

57.48

upper limit

81.77

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

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End point title

Proportion of participants 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

Week 16

End point values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	49	91	87
Units: percentage of participants
number (not applicable)	4.5	52.6	55.4

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

140

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[5]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

24.283

Confidence interval

level

97.5%

sides

2-sided

lower limit

4.386

upper limit

134.432

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 200 mg Q2W (RS)

Number of subjects included in analysis

140

Analysis specification

Pre-specified

Analysis type

superiority

Method

Regression, Logistic

Parameter type

Estimated difference in responder rate

Point estimate

48.1

Confidence interval

level

95%

sides

2-sided

lower limit

35.04

upper limit

61.26

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 400 mg Q2W (RS)

Number of subjects included in analysis

136

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[6]

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

27.204

Confidence interval

level

97.5%

sides

2-sided

lower limit

4.895

upper limit

151.198

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 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

136

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

37.75

upper limit

64.19

Secondary: Proportion of participants who achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (with at least 2-category improvement) response at Week 48

Top of page

End point title

Proportion of participants 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

Week 48

End point values	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed
Units: percentage of participants
number (confidence interval 95%)	72.6 (61.22 to 83.92)	66.6 (54.35 to 78.86)

No statistical analyses for this end point

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

Top of page

End point title

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

End point description

End point type

Secondary

End point timeframe

Week 48

End point values	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed
Units: percentage of participants
number (confidence interval 95%)	78.7 (68.93 to 88.45)	81.3 (71.90 to 90.67)

No statistical analyses for this end point

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

Top of page

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 subjects 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 subjects 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 or 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

Week 16

End point values	Placebo Q2W (RS)	CZP 200 mg Q2W (RS)	CZP 400 mg Q2W (RS)
Number of subjects analysed	49	90	87
Units: Scores on a scale
least squares mean (standard error)	-3.8 ( 0.84 )	-10.4 ( 0.62 )	-10.0 ( 0.64 )

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

139

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[7]

Method

ANCOVA

Parameter type

Adjusted Mean Treatment Differences

Point estimate

-6.62

Confidence interval

level

97.5%

sides

2-sided

lower limit

-8.88

upper limit

-4.36

Notes
[7] - The P-value was 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

136

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[8]

Method

ANCOVA

Parameter type

Adjusted Mean Treatment Differences

Point estimate

-6.19

Confidence interval

level

97.5%

sides

2-sided

lower limit

-8.46

upper limit

-3.93

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

Adverse events

Top of page

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

As per design, participants randomized to PBO either switched to CZP 200mg Q2W or escaped to CZP 400mg Q2W at Week 16, leading to a significantly lower exposure in PBO arm than in CZP arm. Considering the limitations of such comparison, AEs reported while the 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 200 mg Q2W (TCS)

Reporting group description

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

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.

Serious adverse events	CZP 200 mg Q2W (TCS)	CZP 400 mg Q2W (TCS)
Total subjects affected by serious adverse events
subjects affected / exposed	24 / 170 (14.12%)	12 / 149 (8.05%)
number of deaths (all causes)	1	1
number of deaths resulting from adverse events	1	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Non-small cell lung cancer
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	1 / 170 (0.59%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Basal cell carcinoma
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Distributive shock
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Pregnancy, puerperium and perinatal conditions
Pregnancy with contraceptive device
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Anaphylactic reaction
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
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 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Menorrhagia
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Penile swelling
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Genital haemorrhage
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Scrotal swelling
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Laryngeal cyst
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atelectasis
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tonsillar cyst
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Blood count abnormal
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Chest X-ray abnormal
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
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
Contusion
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Cardiac failure congestive
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Migraine
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Multiple sclerosis
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	2 / 170 (1.18%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Disseminated intravascular coagulation
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Eye disorders
Tolosa-Hunt syndrome
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Haemorrhagic necrotic pancreatitis
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Colitis
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pharyngo-oesophageal diverticulum
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Hepatic failure
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Drug-induced liver injury
subjects affected / exposed	2 / 170 (1.18%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Skin ulcer
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Psoriatic arthropathy
subjects affected / exposed	2 / 170 (1.18%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bartholin's abscess
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ovarian abscess
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Varicella
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia legionella
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Chronic sinusitis
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (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
subjects affected / exposed	1 / 170 (0.59%)	0 / 149 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma infection
subjects affected / exposed	0 / 170 (0.00%)	1 / 149 (0.67%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	CZP 200 mg Q2W (TCS)	CZP 400 mg Q2W (TCS)
Total subjects affected by non serious adverse events
subjects affected / exposed	76 / 170 (44.71%)	75 / 149 (50.34%)
Injury, poisoning and procedural complications
Ligament sprain
subjects affected / exposed	8 / 170 (4.71%)	5 / 149 (3.36%)
occurrences all number	8	5
Vascular disorders
Hypertension
subjects affected / exposed	7 / 170 (4.12%)	9 / 149 (6.04%)
occurrences all number	8	9
Nervous system disorders
Headache
subjects affected / exposed	9 / 170 (5.29%)	6 / 149 (4.03%)
occurrences all number	10	6
Skin and subcutaneous tissue disorders
Pruritus
subjects affected / exposed	3 / 170 (1.76%)	8 / 149 (5.37%)
occurrences all number	3	8
Psoriasis
subjects affected / exposed	9 / 170 (5.29%)	12 / 149 (8.05%)
occurrences all number	10	19
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	6 / 170 (3.53%)	8 / 149 (5.37%)
occurrences all number	6	8
Infections and infestations
Nasopharyngitis
subjects affected / exposed	33 / 170 (19.41%)	35 / 149 (23.49%)
occurrences all number	55	45
Upper respiratory tract infection
subjects affected / exposed	19 / 170 (11.18%)	18 / 149 (12.08%)
occurrences all number	20	21
Sinusitis
subjects affected / exposed	13 / 170 (7.65%)	4 / 149 (2.68%)
occurrences all number	15	4
Pharyngitis
subjects affected / exposed	10 / 170 (5.88%)	4 / 149 (2.68%)
occurrences all number	12	4
Urinary tract infection
subjects affected / exposed	11 / 170 (6.47%)	10 / 149 (6.71%)
occurrences all number	15	14

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Were there any global substantial amendments to the protocol? Yes

24 Nov 2015

The Global Protocol Amendment included the following changes: - CIMPASI-2 (name of the PS0002 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 #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 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 participants who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

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

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

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

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

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

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

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

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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 participants who achieve a Psoriasis Activity and Severity Index (PASI75) response at Week 16

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

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

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

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

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

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

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