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

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Scalp Disorders

Rosacea

Rash

Treatment

Tirzepatide

Ixekizumab

Clinical Study ID

NCT06588283
27243
I1F-MC-RHDC
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 PsoriasisArea 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) oroverweight (BMI ≥27 to <30 kg/m²) in the presence of at least 1 of theseweight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleepapnea, cardiovascular disease, or T2DM).

Exclusion

Exclusion Criteria:

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 multipleendocrine neoplasia (MEN) syndrome type 2.

  • Have active, or a history of inflammatory bowel disease (Crohn's or ulcerativecolitis).

  • Have a diagnosis or history of malignant disease within the 5 years prior torandomization, with the following exceptions:

  • basal cell or squamous epithelial carcinomas of the skin that have beenresected, with no evidence of metastatic disease for 3 years.

  • cervical carcinoma in situ, with no evidence of recurrence within the 5 yearsprior 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) orglucagon-like peptide 1 (GLP-1) receptor agonists.

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Tirzepatide
Phase: 3
Study Start date:
September 30, 2024
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • SCB Research Center

    Bayamon, 00961
    Puerto Rico

    Active - Recruiting

  • Office of Dr. Alma M. Cruz

    Carolina, 00985
    Puerto Rico

    Active - Recruiting

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917
    Puerto Rico

    Active - Recruiting

  • Mindful Medical Research

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

  • Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology

    Birmingham, Alabama 35203
    United States

    Active - Recruiting

  • Medical Dermatology Specialists

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Scottsdale Clinical Trials

    Scottsdale, Arizona 85260
    United States

    Active - Recruiting

  • Yuma Clinical Trials

    Yuma, Arizona 85365
    United States

    Active - Recruiting

  • Johnson Dermatology

    Fort Smith, Arkansas 72916
    United States

    Active - Recruiting

  • California Dermatology & Clinical Research Institute

    Encinitas, California 92024
    United States

    Active - Recruiting

  • First OC Dermatology Research Inc

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Avance Clinical Trials

    Laguna Niguel, California 92677
    United States

    Active - Recruiting

  • Dermatology Research Associates

    Los Angeles, California 90045
    United States

    Active - Recruiting

  • Metropolis Dermatology

    Los Angeles, California 90017
    United States

    Active - Recruiting

  • Northridge Clinical Trials

    Northridge, California 91325
    United States

    Active - Recruiting

  • Cura Clinical Research - Oxnard

    Oxnard, California 93030
    United States

    Active - Recruiting

  • Integrative Skin Science and Research - Location 2

    Sacramento, California 95815
    United States

    Active - Recruiting

  • Therapeutics Clinical Research

    San Diego, California 92123
    United States

    Active - Recruiting

  • Life Clinical Trials

    Coral Springs, Florida 33071
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • NeoClinical Research

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Encore Medical Research

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Skin Care Research

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Solutions Through Advanced Research

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Deluxe Health Center

    Miami Lakes, Florida 33014
    United States

    Active - Recruiting

  • Renstar Medical Research

    Ocala, Florida 34470
    United States

    Active - Recruiting

  • Leading Edge Dermatology

    Plantation, Florida 33317
    United States

    Active - Recruiting

  • International Clinical Research - Sanford

    Sanford, Florida 32771
    United States

    Active - Recruiting

  • Nodal Medical Center

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • DeNova Research

    Chicago, Illinois 60602
    United States

    Active - Recruiting

  • Oak Dermatology

    Naperville, Illinois 60563
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • The Indiana Clinical Trials Center, PC

    Plainfield, Indiana 46168
    United States

    Active - Recruiting

  • Equity Medical - Bowling Green

    Bowling Green, Kentucky 42104
    United States

    Active - Recruiting

  • DelRicht Research

    Baton Rouge, Louisiana 70809
    United States

    Active - Recruiting

  • Care Access - Lake Charles (Bayou Pines)

    Lake Charles, Louisiana 70601
    United States

    Active - Recruiting

  • Care Access - Marriottsville

    Marriottsville, Maryland 21104
    United States

    Site Not Available

  • Dermatology and Skin Cancer Specialists, LLC

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Lawrence J. Green, MD, LLC

    Rockville, Maryland 20850
    United States

    Active - Recruiting

  • Great Lakes Research Group, Inc.

    Bay City, Michigan 48706
    United States

    Active - Recruiting

  • The Derm Institute of West Michigan

    Caledonia, Michigan 49316
    United States

    Active - Recruiting

  • MI Skin Innovations

    Northville, Michigan 48167
    United States

    Active - Recruiting

  • JDR Dermatology Research

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Las Vegas Dermatology

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

  • Skin Cancer and Dermatology Institute - Reno

    Reno, Nevada 89509
    United States

    Active - Recruiting

  • ALLCUTIS Research, LLC.

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire 03801
    United States

    Active - Recruiting

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Active - Recruiting

  • Care Access - Hoboken

    Hoboken, New Jersey 07030
    United States

    Active - Recruiting

  • Equity Medical

    New York, New York 10023
    United States

    Active - Recruiting

  • Mount Sinai Doctors - East 85th Street

    New York, New York 10028
    United States

    Active - Recruiting

  • Onsite Clinical Solutions - Huntersville

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Red River Research Partners

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Optima Research - Boardman

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Dermatologists of Southwest Ohio

    Mason, Ohio 45040
    United States

    Active - Recruiting

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Oregon Medical Research Center

    Portland, Oregon 97201
    United States

    Active - Recruiting

  • Dermatology Associates of Plymouth Meeting

    Plymouth Meeting, Pennsylvania 19462
    United States

    Active - Recruiting

  • Columbia Dermatology & Aesthetics

    Columbia, South Carolina 29212
    United States

    Active - Recruiting

  • International Clinical Research - Tennessee LLC

    Murfreesboro, Tennessee 37130
    United States

    Active - Recruiting

  • DelRicht Research - Thompson's Station

    Smyrna, Tennessee 37167
    United States

    Active - Recruiting

  • Tekton Research - Westlake Drive

    Austin, Texas 78746
    United States

    Active - Recruiting

  • Bellaire Dermatology Associates

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Modern Research Associates, PLLC

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Austin Institute for Clinical Research

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Completed

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Active - Recruiting

  • Tanner Clinic

    Layton, Utah 84041
    United States

    Active - Recruiting

  • Care Access - Arlington

    Arlington, Virginia 22206
    United States

    Active - Recruiting

  • Care Access - Danville

    Danville, Virginia 24541
    United States

    Active - Recruiting

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Bellevue Dermatology Clinic

    Bellevue, Washington 98004
    United States

    Active - Recruiting

  • Dermatology of Seattle

    Burien, Washington 98168
    United States

    Active - Recruiting

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