Study of efficacy and safety of secukinumab in subjects with moderate tosevere chronic plaque-type psoriasis

Phase 1

Active, not recruiting

• Conditions: Plaque psoriasis; MedDRA version: 20.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000018190; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-000524-25-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-30
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 536

Inclusion Criteria

* Men or women at least 18 years of age at time of screening.
* Moderate to severe plaque psoriasis Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.
* Candidate for systemic therapy.

Additional inclusion criteria may apply , please refer to the protocol.
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 482
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

* Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, guttate, light sensitive, drug induced)
* Ongoing use of prohibited treatments
* Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
* Pregnant or nursing (lactating) women
* Women of child-bearing potential not willing to use contraception
*Active ongoing inflammatory diseases other than psoriasis or psoriatic arthritis that might confound the evaluation of the benefit of secukinumab therapy
*Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.

Additional exclusion criteria may apply , please refer to the protocol.

Study & Design

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