SIGNATURE study CAIN457AGB01

Phase 1

• Conditions: Moderate to severe active, chronic plaque psoriasis; MedDRA version: 17.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-001855-11-IE
• Lead Sponsor: ovartis Pharmaceuticals UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-15
• Study Completion: 2016-07-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 235

Inclusion Criteria

- Chronic plaque-type psoriasis diagnosed for at least 6 months prior to screening
- Moderate to severe disease severity at randomisation
•PASI =10 and
•DLQI >10
- Failed to respond to systemic therapies including ciclosporin, methotrexate and PUVA/Phototherapy (or is intolerant and/or has a contraindication to these)
- Previously treated with at least one anti-TNFa for moderate or severe psoriasis but is a primary or secondary non-responder.
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 258
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)
- Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium)
- Use of prohibited psoriasis or non-psoriasis treatments
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant unless they use 2 (two) effective forms of contraception during the study and for 16 weeks after stopping treatment.
- Men with a female partner of child bearing potential defined as all women physiologically capable of becoming pregnant unless they use 1 (one) effective form of contraception during the study and for 16 weeks after stopping treatment.
- Plans for administration of live vaccines during the study period or 6 weeks prior to initiation of study drug.

Study & Design

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