Clinical trial NCT06588296: Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
Official title: Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Active Psoriatic Arthritis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 psoriatic arthritis 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 psoriatic arthritis 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 signs and/or symptoms or documented diagnosis of Psoriatic Arthritis (PsA) for at least 6 months and currently fulfilling the classification of Psoriatic Arthritis (CASPAR) criteria.
* Have active PsA, defined as the presence of at least 3 of 68 tender joints and at least 3 of 66 swollen joints.
* 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 a serious disorder or illness other than PsA.
* Have a history of chronic or acute pancreatitis.
* Have any prior use of ixekizumab or tirzepatide.
* Diagnosis of other inflammatory arthritis, such as Rheumatoid Arthritis (RA), ankylosing spondylitis, reactive arthritis, gout, or enteropathic arthritis.
* 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 American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction
timeFrame: Baseline up to Week 36
Secondary outcomes:
measure: Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction
timeFrame: Baseline up to Week 36
measure: Percentage of Participants Achieving ACR50
timeFrame: Baseline up to Week 36
measure: Percentage of Participants Achieving at Least a 10% Weight Reduction
timeFrame: Baseline up to Week 36
Other outcomes:
Locations:
city: Avondale
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
state: Arizona
city: Chandler
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
state: Arizona
city: Flagstaff
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
state: Arizona
city: Gilbert
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
state: Arizona
city: Glendale
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
state: Arizona
city: Mesa
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
state: Arizona
city: Phoenix
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
state: Arizona
city: Sun City
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
state: Arizona
city: Tucson
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
state: Arizona
city: Tucson
country: United States
facility: AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
state: Arizona
city: Apple Valley
country: United States
facility: Medvin Clinical Research - Apple Valley
state: California
city: Covina
country: United States
facility: Medvin Clinical Research - Covina
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: La Mesa
country: United States
facility: Purushotham & Akther Kotha MD, Inc
state: California
city: Riverside
country: United States
facility: Medvin Clinical Research - Riverside
state: California
city: San Diego
country: United States
facility: Rheumatology Center of San Diego
state: California
city: Temecula
country: United States
facility: Medvin Clinical Research - Temecula
state: California
city: Thousand Oaks
country: United States
facility: Cohen Medical Centers
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research - Tujunga
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research - Whittier
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: Hialeah
country: United States
facility: NeoClinical Research
state: Florida
city: Hollywood
country: United States
facility: South Florida Rheumatology
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Kissimmee
country: United States
facility: Vida Clinical Research
state: Florida
city: Margate
country: United States
facility: Life Clinical Trials
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Palm Beach Gardens
country: United States
facility: Vitalia Medical Research
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Tampa
country: United States
facility: International Center for Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Gainesville
country: United States
facility: Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia
state: Georgia
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology
state: Georgia
city: Boise
country: United States
facility: St. Luke's Clinic
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Schaumburg
country: United States
facility: Greater Chicago Specialty Physicians
state: Illinois
city: Skokie
country: United States
facility: Arnold Arthritis & Rheumatology
state: Illinois
city: Willowbrook
country: United States
facility: Willow Rheumatology and Wellness PLLC
state: Illinois
city: Evansville
country: United States
facility: Qualmedica Research, LLC
state: Indiana
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Lake Charles
country: United States
facility: Accurate Clinical Research, Inc
state: Louisiana
city: Cumberland
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Okemos
country: United States
facility: Advanced Rheumatology, PC
state: Michigan
city: Eagan
country: United States
facility: Saint Paul Rheumatology
state: Minnesota
city: Kansas City
country: United States
facility: AARA Clinical Research - Kansas City Physician Partners - North
state: Missouri
city: Saint Louis
country: United States
facility: Arthritis Consultants, Inc.
state: Missouri
city: Springfield
country: United States
facility: Clinvest Headlands Llc
state: Missouri
city: Kalispell
country: United States
facility: Logan Health Research
state: Montana
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Center for Rheumatology
state: New Mexico
city: Santa Fe
country: United States
facility: Inspire Santa Fe Medical Group
state: New Mexico
city: Canton
country: United States
facility: St. Lawrence Health System
state: New York
city: Orchard Park
country: United States
facility: Buffalo Rheumatology and Medicine
state: New York
city: Salisbury
country: United States
facility: Onsite Clinical Solutions, LLC - Brenner Ave
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: RAO Research LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Essential Medical Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Headlands
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Murfreesboro
country: United States
facility: AARA Clinical Research - Murfreesboro Medical Clinic
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, LLC.
state: Texas
city: Baytown
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions - Colleyville
state: Texas
city: Corpus Christi
country: United States
facility: Arthritis Care of Texas
state: Texas
city: Fort Worth
country: United States
facility: AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc
state: Texas
city: Houston
country: United States
facility: Research Physicians Network, LLC
state: Texas
city: Irving
country: United States
facility: AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
state: Texas
city: Katy
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Lubbock
country: United States
facility: West Texas Clinical Research
state: Texas
city: McAllen
country: United States
facility: Valley Arthritis Center
state: Texas
city: Mesquite
country: United States
facility: SouthWest Rheumatology Research, LLC
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston - Woodlands
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - TRA
state: Texas
city: Bellevue
country: United States
facility: Overlake Arthritis and Osteoporosis Center
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Beckley
country: United States
facility: Rheumatology & Pulmonary Clinic
state: West Virginia
city: Caguas
country: Puerto Rico
facility: Centro Reumatologico Caguas
city: Guaynabo
country: Puerto Rico
facility: Reuviva Research Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC - Hato Rey Site
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
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: