ACTIVE_NOT_RECRUITING

Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight

Talk to us

Conditions

PsoriasisObesity

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2024-09-30
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06588283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a diagnosis of moderate-to-severe plaque psoriasis (PsO) for at least 6 months.
  2. * Have both a Static Physician's Global Assessment (sPGA) score of ≥3 and a Psoriasis Area and Severity Index (PASI) ≥12.
  3. * Have ≥10% body surface area (BSA) involvement.
  4. * 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).
  1. * Have Type 1 Diabetes Mellitus (T1DM).
  2. * Have insulin-treated Type 2 Diabetes Mellitus (T2DM).
  3. * Have a prior or planned surgical treatment for obesity.
  4. * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
  5. * Have active, or a history of inflammatory bowel disease (Crohn's or ulcerative colitis).
  6. * Have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions:
  7. * basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years.
  8. * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization.
  9. * Have serious disorder or illness other than PsO.
  10. * Have a history of chronic or acute pancreatitis.
  11. * Have any prior use of ixekizumab or tirzepatide.
  12. * Have a previous failure or intolerance to an interleukin 17 inhibitor (IL-17i) or glucagon-like peptide 1 (GLP-1) receptor agonists.

Contacts and Locations

Principal Investigator

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)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • 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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-30
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-09-30
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

  • Psoriasis
  • Obesity