A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo- And Active-Controlled Study Followed By A Placebo-Controlled Maintenance Period And Open-Label Follow-Up To Evaluate The Efficacy And Safety Of Certolizumab Pegol In Subjects With Moderate To Severe Chronic Plaque Psoriasis - CIMPACT

Phase 1

• Conditions: Plaque Psoriasis; MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000018190; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-003492-36-GB
• Lead Sponsor: CB Biopharma, SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-10
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 561

Inclusion Criteria

1.Provided informed consent
2.Adult men or women =18 years
3.Chronic plaque psoriasis for at least 6 months
4.Baseline psoriasis activity and severity index =12 and body surface area =10% and Physician’s Global Assessments score =3
5.Candidate for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
6.Other protocol-defined inclusion criteria may apply

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Erythrodermic, guttate, generalized pustular form of psoriasis
2.History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol
3.Congestive heart failure
4.History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease
5.History of other malignancy concurrent malignancy as described in the protocol
6.History of, or suspected, demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis)
7.Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 5 months following last dose of study drug. Male subjects who are planning a partner pregnancy during the study or within 10 weeks following the last dose
8.Any other condition which, in the Investigator’s judgment, would make the subject unsuitable for participation in the study
9.Other protocol-defined exclusion criteria may apply
10.Prior etanercept use
11. Subjects with concurrent acute or chronic viral hepatitis B or C or with known human immunodeficiency virus (HIV) infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified