Overview

This trial is active, not recruiting.

Condition psoriasis
Treatments ixekizumab, placebo
Phase phase 2
Sponsor Eli Lilly and Company
Start date April 2010
End date January 2011
Trial size 125 participants
Trial identifier NCT01107457, 12060, I1F-MC-RHAJ

Summary

The primary purpose for this study is to help answer the following research questions

- The safety of ixekizumab (LY2439821) and any side effects that might be associated with it.

- Whether ixekizumab can help participants with Psoriasis.

- How much ixekizumab should be given to participants.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Part A: Administered 10 mg ixekizumab SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.
ixekizumab LY2439821
Administered subcutaneously
(Experimental)
Part A: Administered 25 mg ixekizumab SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.
ixekizumab LY2439821
Administered subcutaneously
(Experimental)
Part A: Administered 75 mg ixekizumab SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.
ixekizumab LY2439821
Administered subcutaneously
(Experimental)
Part A: Administered 150 mg ixekizumab SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.
ixekizumab LY2439821
Administered subcutaneously
(Placebo Comparator)
Part A: Administered on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. Part B: (optional) Administered 120 mg ixekizumab SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.
ixekizumab LY2439821
Administered subcutaneously
placebo
Administered subcutaneously
(Experimental)
Part B: (optional) Administered 120 mg ixekizumab SC every 4 weeks. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236.
ixekizumab LY2439821
Administered subcutaneously
(Experimental)
Part B: (optional) Subsequent to an amendment on May 2012, administration changed to 80 mg ixekizumab every 4 weeks through Week 236.
ixekizumab LY2439821
Administered subcutaneously

Primary Outcomes

Measure
Proportion of Participants who achieve a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) from Baseline to 12 Week Endpoint
time frame: Baseline, 12 Weeks
Percentage of PASI Improvement from Baseline to 12 Week endpoint
time frame: Baseline, 12 Weeks

Secondary Outcomes

Measure
Static Physician's Global Assessment (sPGA) score up to 240 Weeks
time frame: Baseline, up to 240 Weeks
Incidence of Treatment Emergent Adverse Events up to 264 Weeks
time frame: Baseline, up to 264 Weeks
Change from Baseline in Hospital Anxiety and Depression Scale (HADS)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Change from Baseline in 16-item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Change from Baseline in Patient Global Assessment (PatGA)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Change from Baseline in Pain Visual Analog scale (VAS)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Change from Baseline in Medical Outcomes Study Sleep Scale (MOS-S)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Change from Baseline in Psoriasis Medical Care Resource Utilization (PMRU)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAIQ)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Change from Baseline in Medical Outcomes Study Short-Form 36 (SF-36)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Change from Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis
time frame: Baseline, up to 240 Weeks
Change from Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (SPSI) in Participants with Scalp Psoriasis
time frame: Baseline, up to 240 Weeks
Change from Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPSI) in Participants with Palmoplantar Psoriasis
time frame: Baseline, up to 240 Weeks
Plasma Concentrations of ixekizumab from Baseline through 32 Weeks
time frame: Baseline through 32 Weeks
Change in PASI Score from Baseline up to Week 240
time frame: Baseline, up to 240 Weeks
Change from Baseline in Dermatology Life Quality Index (DLQI)
time frame: Baseline, 12 Weeks, 20 Weeks, 32 Weeks, and up to 240 Weeks
Proportion of Participants who achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75) from Baseline through 32 Weeks
time frame: Baseline through 32 Weeks
Percentage of PASI Improvement from Baseline through 32 Weeks
time frame: Baseline through 32 Weeks
Proportion of Participants with a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) with at least a 2 point Improvement from Baseline through 32 Weeks
time frame: Baseline through 32 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria Common to Both Part A and B: - You must have active plaque psoriasis covering at least 10% body surface area and a PASI score of 12 - You are a candidate for systemic therapy - You have a sPGA score of at least 3 at screening and at randomization Inclusion Criterion Specific to Part B - You have completed the treatment period for part A (week 20) Exclusion Criteria Common to Both Part A and B: - You have pustular, erythrodermic and/or guttate forms of psoriasis - You have had a clinically significant flare of psoriasis during the 12 weeks prior to study entry - You are or recently used any biologic agent/monoclonal antibody within the following washout periods: etanercept >28 days, infliximab or adalimumab >56 days, alefacept >60 days, ustekinumab >8 months, or any other biologic agent/monoclonal antibody >5 half-lives prior to baseline - You have received systemic psoriasis therapy (such as psoralen and ultraviolet A [PUVA] light therapy, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, azathioprine) or phototherapy (including ultraviolet B or self-treatment with tanning beds) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization (exception: class 6 [mild, such as desonide] or 7 [least potent, such as hydrocortisone] topical steroids will be permitted for use limited to the face, axilla, and/or genitalia) - You have donated more than 500 mL of blood within the last month - You have another serious disorder or illness - You have suffered a serious bacterial infection (for example, pneumonia, and cellulitis) within the last 3 months - You have a history of uncontrolled high blood pressure - You have clinical laboratory test results at entry that are outside the normal reference range - You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug - You are a woman who is lactating or breast feeding - If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study - If you are a post menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months - If you are a woman between 40-45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate - If you are a male, you must agree to reduce the risk of your female partner becoming pregnant during the study Exclusion Criteria Specific to B: - If you experienced a Serious Adverse Event during Part A considered possibly related to ixekizumab - If you experienced an Adverse Event during Part A that the study doctor believes ixekizumab treatment could cause you harm

Additional Information

Official title A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis
Description The study is a Phase 2 study with 2 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design and Part B is an optional, open label extension design. Approximately 125 participants will be randomized to 1 of 4 ixekizumab groups or to placebo (approximately 25 participants per group) in Part A. Participants will be evaluated for treatment efficacy and the primary endpoint will be evaluated at week 12. Between week 20 and week 32, participants with a less than 75% improvement in their Psoriasis Area and Severity Index (PASI) score compared to baseline will be eligible to begin Part B. Participants in Part B will receive subcutaneous (SC) injections of ixekizumab 120 milligrams (mg) every 4 weeks through week 236. Subsequent to an amendment on May 2012, administration changed to 80 mg every 4 weeks through Week 236. Participants who complete both Part A and B have a total study participation of up to approximately 240 to 264 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.