A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

Lilly

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03073213

I1F-MC-RHBN (Other Identifier)

15371

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Ixekizumab single dose

Experimental group

Description:

Participants received single dose of 80mg Ixekizumab by subcutaneous injection.

Treatment:

Drug: Ixekizumab

Ixekizumab Multiple Regimen 1 (80mg Q2W)

Experimental group

Description:

Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.

Treatment:

Drug: Ixekizumab

Ixekizumab Multiple Regimen 2 (80mg Q4W)

Experimental group

Description:

Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.

Treatment:

Drug: Ixekizumab