Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight
NCT ID: NCT06588283
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2024-09-30
2026-05-31
Brief Summary
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Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.
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NCT06864026
A Phase 3 Study in Participants With Moderate to Severe Psoriasis
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A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ixekizumab
Ixekizumab administered subcutaneous (SC).
Ixekizumab
Administered SC
Ixekizumab and Tirzepatide
Ixekizumab concomitantly administered with tirzepatide SC.
Ixekizumab
Administered SC
Tirzepatide
Administered SC.
Interventions
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Ixekizumab
Administered SC
Tirzepatide
Administered SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥12.
* Have ≥10% body surface area (BSA) involvement.
* Have obesity, body mass index of ≥30 kilograms per meter squared (BMI ≥30 kg/m²) or overweight (BMI ≥27 to \<30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2DM).
Exclusion Criteria
* Have Type 1 Diabetes Mellitus (T1DM).
* Have insulin-treated Type 2 Diabetes Mellitus (T2DM).
* Have a prior or planned surgical treatment for obesity.
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
* Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis).
* Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions:
* basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years.
* cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization.
* Have serious disorder or illness other than PsO.
* Have a history of chronic or acute pancreatitis.
* Have any prior use of ixekizumab or tirzepatide.
* Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham, Alabama, United States
Medical Dermatology Specialists
Phoenix, Arizona, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, United States
Yuma Clinical Trials
Yuma, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
California Dermatology & Clinical Research Institute
Encinitas, California, United States
First OC Dermatology Research Inc
Fountain Valley, California, United States
Avance Clinical Trials
Laguna Niguel, California, United States
Metropolis Dermatology
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Northridge Clinical Trials
Northridge, California, United States
Cura Clinical Research - Oxnard
Oxnard, California, United States
Integrative Skin Science and Research - Location 2
Sacramento, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Life Clinical Trials
Coral Springs, Florida, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, United States
NeoClinical Research
Hialeah, Florida, United States
Skin Care Research
Hollywood, Florida, United States
Encore Medical Research
Hollywood, Florida, United States
Solutions Through Advanced Research
Jacksonville, Florida, United States
Deluxe Health Center
Miami Lakes, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Leading Edge Dermatology
Plantation, Florida, United States
International Clinical Research - Sanford
Sanford, Florida, United States
Nodal Medical Center
Tampa, Florida, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
DeNova Research
Chicago, Illinois, United States
Oak Dermatology
Naperville, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, United States
DelRicht Research
Baton Rouge, Louisiana, United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, United States
Lawrence J. Green, MD, LLC
Rockville, Maryland, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
The Derm Institute of West Michigan
Caledonia, Michigan, United States
MI Skin Innovations
Northville, Michigan, United States
Las Vegas Dermatology
Las Vegas, Nevada, United States
Skin Cancer and Dermatology Institute - Reno
Reno, Nevada, United States
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
Care Access - Hoboken
Hoboken, New Jersey, United States
Equity Medical
New York, New York, United States
Mount Sinai Doctors - East 85th Street
New York, New York, United States
Onsite Clinical Solutions - Huntersville
Huntersville, North Carolina, United States
Red River Research Partners
Fargo, North Dakota, United States
Optima Research - Boardman
Boardman, Ohio, United States
Dermatologists of Southwest Ohio
Mason, Ohio, United States
Oregon Medical Research Center
Portland, Oregon, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Columbia Dermatology & Aesthetics
Columbia, South Carolina, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
DelRicht Research - Thompson's Station
Smyrna, Tennessee, United States
Tekton Research - Westlake Drive
Austin, Texas, United States
Bellaire Dermatology Associates
Bellaire, Texas, United States
Modern Research Associates, PLLC
Dallas, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Tanner Clinic
Layton, Utah, United States
Care Access - Arlington
Arlington, Virginia, United States
Care Access - Danville
Danville, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Bellevue Dermatology Clinic
Bellevue, Washington, United States
Dermatology of Seattle
Burien, Washington, United States
SCB Research Center
Bayamón, , Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, , Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, , Puerto Rico
Mindful Medical Research
San Juan, , Puerto Rico
Countries
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Other Identifiers
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I1F-MC-RHDC
Identifier Type: OTHER
Identifier Source: secondary_id
27243
Identifier Type: -
Identifier Source: org_study_id
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