Clinical trial NCT06588283: Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Psoriasis
Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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).

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 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.

Primary outcomes:
measure: Percentage of Participants Who Simultaneously Achieved Psoriasis Area and Severity Index (PASI) 100 and At Least 10% Weight Reduction
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Percentage of Participants Who Simultaneously Achieved PASI 75 and At Least 5% Weight Reduction
timeFrame: Baseline to Week 36
measure: Percentage of Participants Achieving PASI 100
timeFrame: Baseline to Week 36
measure: Percentage of Participants Achieving At Least 10% Weight Reduction
timeFrame: Baseline to Week 36
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Yuma
country: United States
facility: Yuma Clinical Trials
state: Arizona
city: Fort Smith
country: United States
facility: Johnson Dermatology
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology Research Inc
state: California
city: Laguna Niguel
country: United States
facility: Avance Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Metropolis Dermatology
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials
state: California
city: Oxnard
country: United States
facility: Cura Clinical Research - Oxnard
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research - Location 2
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Coral Springs
country: United States
facility: Life Clinical Trials
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Hialeah
country: United States
facility: NeoClinical Research
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research
state: Florida
city: Miami Lakes
country: United States
facility: Deluxe Health Center
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Plantation
country: United States
facility: Leading Edge Dermatology
state: Florida
city: Sanford
country: United States
facility: International Clinical Research - Sanford
state: Florida
city: Tampa
country: United States
facility: Nodal Medical Center
state: Florida
city: Tampa
country: United States
facility: Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
state: Florida
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Naperville
country: United States
facility: Oak Dermatology
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center, PC
state: Indiana
city: Bowling Green
country: United States
facility: Equity Medical - Bowling Green
state: Kentucky
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Lake Charles
country: United States
facility: Care Access - Lake Charles (Bayou Pines)
state: Louisiana
city: Rockville
country: United States
facility: Dermatology and Skin Cancer Specialists, LLC
state: Maryland
city: Rockville
country: United States
facility: Lawrence J. Green, MD, LLC
state: Maryland
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Caledonia
country: United States
facility: The Derm Institute of West Michigan
state: Michigan
city: Northville
country: United States
facility: MI Skin Innovations
state: Michigan
city: Las Vegas
country: United States
facility: Las Vegas Dermatology
state: Nevada
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute - Reno
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, LLC.
state: New Hampshire
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Hoboken
country: United States
facility: Care Access - Hoboken
state: New Jersey
city: New York
country: United States
facility: Equity Medical
state: New York
city: New York
country: United States
facility: Mount Sinai Doctors - East 85th Street
state: New York
city: Huntersville
country: United States
facility: Onsite Clinical Solutions - Huntersville
state: North Carolina
city: Fargo
country: United States
facility: Red River Research Partners
state: North Dakota
city: Boardman
country: United States
facility: Optima Research - Boardman
state: Ohio
city: Mason
country: United States
facility: Dermatologists of Southwest Ohio
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Dermatology & Aesthetics
state: South Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research - Tennessee LLC
state: Tennessee
city: Smyrna
country: United States
facility: DelRicht Research - Thompson's Station
state: Tennessee
city: Austin
country: United States
facility: Tekton Research - Westlake Drive
state: Texas
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Arlington
country: United States
facility: Care Access - Arlington
state: Virginia
city: Danville
country: United States
facility: Care Access - Danville
state: Virginia
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Bellevue Dermatology Clinic
state: Washington
city: Burien
country: United States
facility: Dermatology of Seattle
state: Washington
city: Bayamon
country: Puerto Rico
facility: SCB Research Center
city: Carolina
country: Puerto Rico
facility: Office of Dr. Alma M. Cruz
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: