Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsO)

Status: Active_not_recruiting
Location: See all (72) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Alabama
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham
Arkansas
Johnson Dermatology
Fort Smith
Arizona
Medical Dermatology Specialists
Phoenix
Scottsdale Clinical Trials
Scottsdale
Yuma Clinical Trials
Yuma
California
California Dermatology & Clinical Research Institute
Encinitas
First OC Dermatology Research Inc
Fountain Valley
Avance Clinical Trials
Laguna Niguel
Dermatology Research Associates
Los Angeles
Metropolis Dermatology
Los Angeles
Northridge Clinical Trials
Northridge
Cura Clinical Research - Oxnard
Oxnard
Integrative Skin Science and Research - Location 2
Sacramento
Therapeutics Clinical Research
San Diego
Florida
Life Clinical Trials
Coral Springs
Alliance for Multispecialty Research, LLC
Fort Myers
NeoClinical Research
Hialeah
Encore Medical Research
Hollywood
Skin Care Research
Hollywood
Solutions Through Advanced Research
Jacksonville
Deluxe Health Center
Miami Lakes
Renstar Medical Research
Ocala
Leading Edge Dermatology
Plantation
International Clinical Research - Sanford
Sanford
Nodal Medical Center
Tampa
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa
Illinois
DeNova Research
Chicago
Oak Dermatology
Naperville
Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
The Indiana Clinical Trials Center, PC
Plainfield
Kentucky
Equity Medical - Bowling Green
Bowling Green
Louisiana
DelRicht Research
Baton Rouge
Care Access - Lake Charles (Bayou Pines)
Lake Charles
Maryland
Dermatology and Skin Cancer Specialists, LLC
Rockville
Lawrence J. Green, MD, LLC
Rockville
Michigan
Great Lakes Research Group, Inc.
Bay City
The Derm Institute of West Michigan
Caledonia
MI Skin Innovations
Northville
North Carolina
Onsite Clinical Solutions - Huntersville
Huntersville
North Dakota
Red River Research Partners
Fargo
New Hampshire
ActivMed Practices & Research, LLC.
Portsmouth
New Jersey
Psoriasis Treatment Center of Central New Jersey
East Windsor
Care Access - Hoboken
Hoboken
Nevada
Las Vegas Dermatology
Las Vegas
Skin Cancer and Dermatology Institute - Reno
Reno
New York
Equity Medical
New York
Mount Sinai Doctors - East 85th Street
New York
Ohio
Optima Research - Boardman
Boardman
Dermatologists of Southwest Ohio
Mason
Oregon
Oregon Dermatology and Research Center
Portland
Oregon Medical Research Center
Portland
Pennsylvania
Dermatology Associates of Plymouth Meeting
Plymouth Meeting
South Carolina
Columbia Dermatology & Aesthetics
Columbia
Tennessee
International Clinical Research - Tennessee LLC
Murfreesboro
DelRicht Research - Thompson's Station
Smyrna
Texas
Tekton Research - Westlake Drive
Austin
Bellaire Dermatology Associates
Bellaire
Modern Research Associates, PLLC
Dallas
Austin Institute for Clinical Research
Pflugerville
Dermatology Clinical Research Center of San Antonio
San Antonio
Progressive Clinical Research
San Antonio
Texas Dermatology and Laser Specialists
San Antonio
Utah
Tanner Clinic
Layton
Virginia
Care Access - Arlington
Arlington
Care Access - Danville
Danville
Virginia Clinical Research, Inc.
Norfolk
Washington
Bellevue Dermatology Clinic
Bellevue
Dermatology of Seattle
Burien
Other Locations
Puerto Rico
SCB Research Center
Bayamón
Office of Dr. Alma M. Cruz
Carolina
GCM Medical Group, PSC - Hato Rey Site
San Juan
Mindful Medical Research
San Juan
Time Frame
Start Date: 2024-09-30
Completion Date: 2026-05
Participants
Target number of participants: 250
Treatments
Experimental: Ixekizumab
Ixekizumab administered subcutaneous (SC).
Experimental: Ixekizumab and Tirzepatide
Ixekizumab concomitantly administered with tirzepatide SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov