Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight
TOGETHER-PsO
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)
2 other identifiers
interventional
250
2 countries
72
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2024
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
September 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 8, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJanuary 20, 2026
January 1, 2026
1.3 years
September 4, 2024
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction
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.
Baseline to Week 36
Secondary Outcomes (3)
Percentage of Participants Who Simultaneously Achieved PASI 75 and At Least 5% Weight Reduction
Baseline to Week 36
Percentage of Participants Achieving PASI 100
Baseline to Week 36
Percentage of Participants Achieving At Least 10% Weight Reduction
Baseline to Week 36
Study Arms (2)
Ixekizumab
EXPERIMENTALIxekizumab administered subcutaneous (SC).
Ixekizumab and Tirzepatide
EXPERIMENTALIxekizumab concomitantly administered with tirzepatide SC.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
Birmingham, Alabama, 35203, United States
Medical Dermatology Specialists
Phoenix, Arizona, 85006, United States
Scottsdale Clinical Trials
Scottsdale, Arizona, 85260, United States
Yuma Clinical Trials
Yuma, Arizona, 85365, United States
Johnson Dermatology
Fort Smith, Arkansas, 72916, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
First OC Dermatology Research Inc
Fountain Valley, California, 92708, United States
Avance Clinical Trials
Laguna Niguel, California, 92677, United States
Metropolis Dermatology
Los Angeles, California, 90017, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Northridge Clinical Trials
Northridge, California, 91325, United States
Cura Clinical Research - Oxnard
Oxnard, California, 93030, United States
Integrative Skin Science and Research - Location 2
Sacramento, California, 95815, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Life Clinical Trials
Coral Springs, Florida, 33071, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, 33912, United States
NeoClinical Research
Hialeah, Florida, 33016, United States
Skin Care Research
Hollywood, Florida, 33021, United States
Encore Medical Research
Hollywood, Florida, 33024, United States
Solutions Through Advanced Research
Jacksonville, Florida, 32256, United States
Deluxe Health Center
Miami Lakes, Florida, 33014, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Leading Edge Dermatology
Plantation, Florida, 33317, United States
International Clinical Research - Sanford
Sanford, Florida, 32771, United States
Nodal Medical Center
Tampa, Florida, 33607, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida, 33609, United States
DeNova Research
Chicago, Illinois, 60602, United States
Oak Dermatology
Naperville, Illinois, 60563, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Equity Medical - Bowling Green
Bowling Green, Kentucky, 42104, United States
DelRicht Research
Baton Rouge, Louisiana, 70809, United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, 70601, United States
Dermatology and Skin Cancer Specialists, LLC
Rockville, Maryland, 20850, United States
Lawrence J. Green, MD, LLC
Rockville, Maryland, 20850, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
The Derm Institute of West Michigan
Caledonia, Michigan, 49316, United States
MI Skin Innovations
Northville, Michigan, 48167, United States
Las Vegas Dermatology
Las Vegas, Nevada, 89144, United States
Skin Cancer and Dermatology Institute - Reno
Reno, Nevada, 89509, United States
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, 03801, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520, United States
Care Access - Hoboken
Hoboken, New Jersey, 07030, United States
Equity Medical
New York, New York, 10023, United States
Mount Sinai Doctors - East 85th Street
New York, New York, 10028, United States
Onsite Clinical Solutions - Huntersville
Huntersville, North Carolina, 28078, United States
Red River Research Partners
Fargo, North Dakota, 58103, United States
Optima Research - Boardman
Boardman, Ohio, 44512, United States
Dermatologists of Southwest Ohio
Mason, Ohio, 45040, United States
Oregon Medical Research Center
Portland, Oregon, 97201, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462, United States
Columbia Dermatology & Aesthetics
Columbia, South Carolina, 29212, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, 37130, United States
DelRicht Research - Thompson's Station
Smyrna, Tennessee, 37167, United States
Tekton Research - Westlake Drive
Austin, Texas, 78746, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
Austin Institute for Clinical Research
Pflugerville, Texas, 78660, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Tanner Clinic
Layton, Utah, 84041, United States
Care Access - Arlington
Arlington, Virginia, 22206, United States
Care Access - Danville
Danville, Virginia, 24541, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502, United States
Bellevue Dermatology Clinic
Bellevue, Washington, 98004, United States
Dermatology of Seattle
Burien, Washington, 98168, United States
SCB Research Center
Bayamón, 00961, Puerto Rico
Office of Dr. Alma M. Cruz
Carolina, 00985, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
San Juan, 00917, Puerto Rico
Mindful Medical Research
San Juan, 00918, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2024
First Posted
September 19, 2024
Study Start
September 30, 2024
Primary Completion
January 8, 2026
Study Completion
May 1, 2026
Last Updated
January 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.