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)
Status: Active_not_recruiting
Location: See all (86) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arizona
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
Avondale
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
Chandler
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
Flagstaff
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
Gilbert
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
Glendale
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
Mesa
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
Phoenix
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
Sun City
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
Tucson
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
Tucson
California
Medvin Clinical Research - Apple Valley
Apple Valley
Medvin Clinical Research - Covina
Covina
Newport Huntington Medical Group
Huntington Beach
Purushotham & Akther Kotha MD, Inc
La Mesa
Medvin Clinical Research - Riverside
Riverside
Rheumatology Center of San Diego
San Diego
Medvin Clinical Research - Temecula
Temecula
Cohen Medical Centers
Thousand Oaks
Medvin Clinical Research - Tujunga
Tujunga
Medvin Clinical Research - Whittier
Whittier
Colorado
Denver Arthritis Clinic
Denver
Florida
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater
NeoClinical Research
Hialeah
South Florida Rheumatology
Hollywood
Jacksonville Center for Clinical Research
Jacksonville
Vida Clinical Research
Kissimmee
Life Clinical Trials
Margate
Suncoast Clinical Research, Inc.
New Port Richey
Vitalia Medical Research
Palm Beach Gardens
Sarasota Arthritis Center
Sarasota
Clinical Research of West Florida
Tampa
International Center for Research
Tampa
Conquest Research
Winter Park
Georgia
Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia
Gainesville
Atlanta Research Center for Rheumatology
Marietta
Idaho
St. Luke's Clinic
Boise
Illinois
Great Lakes Clinical Trials - Ravenswood
Chicago
Greater Chicago Specialty Physicians
Schaumburg
Arnold Arthritis & Rheumatology
Skokie
Willow Rheumatology and Wellness PLLC
Willowbrook
Indiana
Qualmedica Research, LLC
Evansville
Kansas
Alliance for Multispecialty Research, LLC
Wichita
Louisiana
Accurate Clinical Research, Inc
Lake Charles
Massachusetts
NECCR PrimaCare Research
Fall River
Maryland
Klein & Associates, M.D., P.A.
Cumberland
Klein & Associates, M.D., P.A.
Hagerstown
Michigan
Advanced Rheumatology, PC
Okemos
Minnesota
Saint Paul Rheumatology
Eagan
Missouri
AARA Clinical Research - Kansas City Physician Partners - North
Kansas City
Clinvest Headlands Llc
Springfield
Arthritis Consultants, Inc.
St Louis
Montana
Logan Health Research
Kalispell
North Carolina
Onsite Clinical Solutions, LLC - Brenner Ave
Salisbury
Nebraska
Physician Research Collaboration, LLC
Lincoln
New Mexico
Albuquerque Center for Rheumatology
Albuquerque
Inspire Santa Fe Medical Group
Santa Fe
New York
St. Lawrence Health System
Canton
Ohio
Paramount Medical Research & Consulting, LLC
Middleburg Heights
Oklahoma
RAO Research LLC
Oklahoma City
Essential Medical Research
Tulsa
Oregon
Summit Headlands
Portland
Pennsylvania
Altoona Center For Clinical Research
Duncansville
Tennessee
West Tennessee Research Institute
Jackson
AARA Clinical Research - Murfreesboro Medical Clinic
Murfreesboro
Texas
Tekton Research, LLC.
Austin
Accurate Clinical Management, LLC
Baytown
Precision Comprehensive Clinical Research Solutions - Colleyville
Colleyville
Arthritis Care of Texas
Corpus Christi
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
Fort Worth
Accurate Clinical Research, Inc
Houston
Research Physicians Network, LLC
Houston
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
Irving
Biopharma Informatic, LLC
Katy
West Texas Clinical Research
Lubbock
Valley Arthritis Center
Mcallen
SouthWest Rheumatology Research, LLC
Mesquite
Advanced Rheumatology of Houston - Woodlands
The Woodlands
DM Clinical Research - TRA
Tomball
Washington
Overlake Arthritis and Osteoporosis Center
Bellevue
Arthritis Northwest, PLLC
Spokane
West Virginia
Rheumatology & Pulmonary Clinic
Beckley
Other Locations
Puerto Rico
Centro Reumatologico Caguas
Caguas
Reuviva Research Center
Guaynabo
Caribbean Medical Research Center
San Juan
GCM Medical Group, PSC - Hato Rey Site
San Juan
Mindful Medical Research
San Juan
Time Frame
Start Date: 2024-09-24
Completion Date: 2026-04
Participants
Target number of participants: 250
Treatments
Experimental: Ixekizumab
Ixekizumab administered subcutaneous (SC).
Experimental: Ixekizumab and Tirzepatide
Ixekizumab concomitantly administered with tirzepatide SC.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company