Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight
- Registration Number
- NCT06588283
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months.
- 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).
Medical Conditions
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ixekizumab and Tirzepatide Tirzepatide Ixekizumab concomitantly administered with tirzepatide SC. Ixekizumab Ixekizumab Ixekizumab administered subcutaneous (SC). Ixekizumab and Tirzepatide Ixekizumab Ixekizumab concomitantly administered with tirzepatide SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction Baseline to Week 36 PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor (head \[0.1\], upper limbs \[0.2\], trunk \[0.3\], lower limbs \[0.4\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease).Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI score compared to baseline.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Simultaneously Achieved PASI 75 and At Least 5% Weight Reduction Baseline to Week 36 PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately, and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor (head \[0.1\], upper limbs \[0.2\], trunk \[0.3\], lower limbs \[0.4\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.
Percentage of Participants Achieving PASI 100 Baseline to Week 36 PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (none) to 4 (very severe). Each area is scored separately, and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor (head \[0.1\], upper limbs \[0.2\], trunk \[0.3\], lower limbs \[0.4\]). Overall scores range from 0 (no psoriasis) to 72 (the most severe disease). Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.
Percentage of Participants Achieving At Least 10% Weight Reduction Baseline to Week 36 Percentage of Participants Who Achieved at Least a 10% Weight Reduction
Trial Locations
- Locations (72)
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
🇵🇷Bayamon, 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