Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis (UNCOVER-A)

Lilly

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Ixekizumab Prefilled Syringe; Drug: Ixekizumab Auto-Injector

Study type: Interventional

Funder types: Industry

Identifiers

NCT01777191

I1F-MC-RHBL (Other Identifier)

14728

Details and patient eligibility

About

The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.

Enrollment: 204 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-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: None (Open label)

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204 participants in 2 patient groups

80 mg Ixekizumab Auto-Injector

Experimental group

Description:

Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every 2 weeks (Q2W) at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection every 4 weeks (Q4W).

Treatment:

Drug: Ixekizumab Auto-Injector

80 mg Ixekizumab Prefilled Syringe

Experimental group

Description:

Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection Q4W.

Treatment:

Drug: Ixekizumab Prefilled Syringe