A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474512

I1F-MC-RHAZ (Other Identifier)

12972

Details and patient eligibility

About

This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.

Enrollment: 1,296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization
• At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
• 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 randomization
• Candidate for phototherapy and/or systemic therapy
• 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

Exclusion criteria

• Pustular, erythrodermic, and/or guttate forms of psoriasis
• History of drug-induced psoriasis
• Clinically significant flare of psoriasis during the 12 weeks prior to randomization
• 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 randomization
• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
• Have participated in any study with interleukin (IL)-17 antagonists, including LY2439821
• Serious disorder or illness other than plaque psoriasis
• Serious infection within the last 3 months
• Breastfeeding or nursing (lactating) women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,296 participants in 4 patient groups, including a placebo group

80 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W)

Experimental group

Description:

Administered as two 80-mg subcutaneous (SC) injections at Week 0, then one 80-mg SC injection per Dosing Regimen 1 \[every 2 weeks (Q2W)\] up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 \[every 4 weeks (Q4W)\] or Dosing Regimen 3 \[every 12 weeks Q12W)\].

Treatment:

Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3

80 mg Ixekizumab Dosing Regimen 2 (Q4W)

Experimental group

Description:

Administered as two 80-mg SC injections at Week 0, then one 80-mg SC injection per Dosing Regimen 2 (Q4W) up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 (Q4W) or Dosing Regimen 3 (Q12W).

Treatment:

Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3

80 mg Ixekizumab Dosing Regimen 3 (Q12W)

Experimental group

Description:

Dosing Regimen 3 (Q12W) is not used until Week 12. At Week 12, participants who were re-randomized to this arm were administered one 80-mg SC injection Q12W.

Treatment:

Drug: 80 mg Ixekizumab Dosing Regimens 1, 2, and 3

Placebo

Placebo Comparator group

Description:

Administered as 2 SC injections at Week 0, then 1 SC injection per Dosing Regimen 1 (Q2W) up to and including Week 10. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2 (Q4W).

Treatment:

Drug: Placebo