A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: 50 mg etanercept; Drug: Placebo; Drug: 80 mg ixekizumab Dosing Regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01597245

12973

I1F-MC-RHBA (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,224 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 plaque psoriasis for at least 6 months prior to first dose of study drug
• At least 10% Body Surface Area (BSA) of psoriasis at screening and at first dose of study drug
• 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 first dose of study drug
• Candidate for phototherapy and/or systemic therapy
• Men must agree to use a reliable method of birth control or remain abstinent during the study
• Women must agree to use reliable 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
• Prior use of etanercept
• Clinically significant flare of psoriasis during the 12 weeks prior to randomization
• Concurrent or recent use of any biologic agent
• Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A [PUVA], ultraviolet B [UVB]) 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 17 (IL-17) antagonists, including ixekizumab
• 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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1,224 participants in 5 patient groups, including a placebo group

80 mg ixekizumab Dosing Regimen 1

Experimental group

Description:

Administered by two 80 mg subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.

Treatment:

Drug: 80 mg ixekizumab Dosing Regimen

80 mg ixekizumab Dosing Regimen 2

Experimental group

Description:

Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.

Treatment:

Drug: 80 mg ixekizumab Dosing Regimen

80 mg ixekizumab Dosing Regimen 3

Experimental group

Description:

Dosing Regimen 3 is not used until Week 12. At Week 12, ixekizumab responders re-randomized to this arm will receive Dosing Regimen 3.

Treatment:

Drug: 80 mg ixekizumab Dosing Regimen

50 mg etanercept

Active Comparator group

Description:

Administered by one 50 mg SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, etanercept responders are assigned to placebo, and nonresponders to Dosing Regimen 2.

Treatment:

Drug: 50 mg etanercept

Placebo for ixekizumab

Placebo Comparator group

Description:

Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. At Week 12, placebo responders are assigned to placebo, and nonresponders to Dosing Regimen 2. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12 was used to blind etanercept injections for Dosing Regimen 1, Dosing Regimen 2, and Placebo Comparator groups.

Treatment:

Drug: Placebo