A Study in Japanese Participants With Moderate-to-Severe Psoriasis (UNCOVER-J)

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: 80 mg ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01624233

13976

I1F-JE-RHAT (Other Identifier)

Details and patient eligibility

About

This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.

Enrollment: 91 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men must agree to use a reliable method of birth control during the study
• Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
• Candidates for phototherapy and/or systemic therapy
• Present with chronic psoriasis based on a confirmed psoriasis diagnosis for at least 6 months prior to enrollment
• At least 10% Body Surface Area (BSA) of Psoriasis at screening and at enrollment for participants with plaque psoriasis
• Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at enrollment for participants with plaque psoriasis

Exclusion criteria

• History of drug-induced psoriasis
• Concurrent or recent use of any biologic agent
• Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment for participants with plaque psoriasis
• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
• Have participated in any study with interleukin-17(IL-17) antagonists, including ixekizumab
• Serious disorder or illness other than psoriasis
• Serious infection within the last 3 months
• Breastfeeding or nursing (lactating) women
• Clinically significant flare of psoriasis during the 12 weeks prior to enrollment for participants with plaque psoriasis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

80 mg ixekizumab

Experimental group

Description:

Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 up to Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 up to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.

Treatment:

Drug: 80 mg ixekizumab