A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,346
- Locations
- 1
- Primary Endpoint
- Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis 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 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
Arms & Interventions
Placebo
Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, participants are assigned to Dosing Regimen 2.
Intervention: Placebo (Drug)
50 mg etanercept
Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2
Intervention: 50 mg etanercept (Drug)
80 mg ixekizumab Dosing Regimen 2
Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 264.
Intervention: 80 mg ixekizumab (Drug)
80 mg ixekizumab Dosing Regimen 1
Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is assigned to Dosing Regimen 2.
Intervention: 80 mg ixekizumab (Drug)
Outcomes
Primary Outcomes
Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)
Time Frame: Week 12
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.
Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)
Time Frame: Week 12
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.
Secondary Outcomes
- Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement(Week 12)
- Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies(Week 12)
- Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)(Week 12)
- Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)(Week 12)
- Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)(Week 12)
- Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)](Week 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score(Baseline, Week 12)
- Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score(Baseline, Week 12)
- Percent of Body Surface Area (BSA) Involvement of Psoriasis(Week 12)
- Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score(Baseline, Week 12)
- Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)](Baseline, Week 12)
- Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)(Baseline, Week 12)
- Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores(Baseline, Week 12)
- Change From Baseline in Patient's Global Assessment of Disease Severity(Baseline, Week 12)
- Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement(Week 12)
- Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement(Week 12)