A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

• Status: Completed
• Trial end date: 2019-05-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Ixekizumab

Criteria

Inclusion Criteria:

• Males or females aged ≥18 years.

• Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.

• Candidates for phototherapy and/or systemic therapy.

• ≥10% body surface area (BSA) involvement at screening and baseline.

• static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.

Exclusion Criteria:

• Clinically significant flare of psoriasis during the 12 weeks before baseline.

• Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline .

• Current or recent use of any biologic agent within the required washout periods.

• Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.