Study to assess the differences in terms of efficacy and safety of secukinumab between patients Cw6 negative and Cw6 positive with moderate to severe plaque psoriasis

Phase 1

• Conditions: moderate to severe chronic plaque-type psoriasis; MedDRA version: 17.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-002865-31-IT
• Lead Sponsor: OVARTIS FARMA S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-15
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.
2. Men or women at least 18 years of age at time of screening.
3. Diagnosis of moderate to severe chronic plaque-type psoriasis for at least 6 months.
4. Psoriasis of the scalp, hands or diagnosis of concomitant psoriatic arthritis as per CASPAR criteria.
5. Moderate to severe psoriasis as defined at enrollment by:
? PASI score = 10
or
? PASI score > 5 but < 10 and DLQI =10
6. Failed response to at least two systemic therapies (i.e. cyclosporine, methotrexate and PUVA) or to an anti-TNFa (or is intolerant and/or has a contraindication to these).
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis).
2. Cyclosporine or methotrexate therapy within 4 weeks prior to Day 1.
3. Anti-TNFa therapy within timelines depending on drug half-life.
4. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
5. Previous exposure to ustekinumab or any other biologic drug for the treatment of psoriasis that is not anti-TNFa therapy.
6. Intravenous or intramuscular steroids within 2 weeks prior to screening and during screening.
7. Ongoing use of corticosteroid topical treatments or UV therapy.

Study & Design

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