Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Psoriatic Arthritis and Obesity or Overweight
- Conditions
- Psoriatic ArthritisObesity
- Interventions
- Registration Number
- NCT06588296
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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).
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ixekizumab and Tirzepatide Ixekizumab Ixekizumab concomitantly administered with tirzepatide SC. Ixekizumab Ixekizumab Ixekizumab administered subcutaneous (SC). Ixekizumab and Tirzepatide Tirzepatide Ixekizumab concomitantly administered with tirzepatide SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction Baseline up to Week 36 ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of Tender Joint Count (TJC) (0-68) and Swollen Joint Count (SJC) (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments:
1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)
- Secondary Outcome Measures
Name Time Method Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction Baseline up to Week 36 ACR20 is defined as at least 20% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 20% in the number of TJC (0-68) and SJC (0-66) and an improvement of at least 20% in at least 3 of these 5 assessments:
1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)Percentage of Participants Achieving ACR50 Baseline up to Week 36 ACR50 is defined as at least 50% improvement in the ACR core set values. The percentage improvement in the ACR scores is determined by an improvement of at least 50% in the number of TJC (0-68) and SJC (0-66) and an improvement of at least 50% in at least 3 of these 5 assessments:
1. Patient's Assessment of Arthritis Pain Visual Analog Scale (VAS)
2. Patient's Global Assessment of Disease Activity Numeric Rating Scale (PaGADA _NRS)
3. Physician's Global Assessment of Disease Activity Numeric Rating Scale (PhGADA NRS)
4. Patient's Assessment of Physical Function as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) or
5. Acute phase reactant as measured by High-Sensitivity C-Reactive Protein (hsCRP)Percentage of Participants Achieving at Least a 10% Weight Reduction Baseline up to Week 36 Percentage of Participants Who Achieved at Least a 10% Weight Reduction
Trial Locations
- Locations (87)
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale
🇺🇸Avondale, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler
🇺🇸Chandler, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff
🇺🇸Flagstaff, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert
🇺🇸Gilbert, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale
🇺🇸Glendale, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa
🇺🇸Mesa, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV
🇺🇸Phoenix, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City
🇺🇸Sun City, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson
🇺🇸Tucson, Arizona, United States
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast
🇺🇸Tucson, Arizona, United States
Medvin Clinical Research - Apple Valley
🇺🇸Apple Valley, California, United States
Medvin Clinical Research - Covina
🇺🇸Covina, California, United States
Newport Huntington Medical Group
🇺🇸Huntington Beach, California, United States
Purushotham & Akther Kotha MD, Inc
🇺🇸La Mesa, California, United States
Medvin Clinical Research - Riverside
🇺🇸Riverside, California, United States
Rheumatology Center of San Diego
🇺🇸San Diego, California, United States
Medvin Clinical Research - Temecula
🇺🇸Temecula, California, United States
Cohen Medical Centers
🇺🇸Thousand Oaks, California, United States
Medvin Clinical Research - Tujunga
🇺🇸Tujunga, California, United States
Medvin Clinical Research - Whittier
🇺🇸Whittier, California, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Clinical Research of West Florida, Inc. (Clearwater)
🇺🇸Clearwater, Florida, United States
NeoClinical Research
🇺🇸Hialeah, Florida, United States
South Florida Rheumatology
🇺🇸Hollywood, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Vida Clinical Research
🇺🇸Kissimmee, Florida, United States
Life Clinical Trials
🇺🇸Margate, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Vitalia Medical Research
🇺🇸Palm Beach Gardens, Florida, United States
Sarasota Arthritis Center
🇺🇸Sarasota, Florida, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
International Center for Research
🇺🇸Tampa, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia
🇺🇸Gainesville, Georgia, United States
Atlanta Research Center for Rheumatology
🇺🇸Marietta, Georgia, United States
Bingham Memorial Hospital
🇺🇸Blackfoot, Idaho, United States
St. Luke's Clinic
🇺🇸Boise, Idaho, United States
Great Lakes Clinical Trials - Ravenswood
🇺🇸Chicago, Illinois, United States
Greater Chicago Specialty Physicians
🇺🇸Schaumburg, Illinois, United States
Arnold Arthritis & Rheumatology
🇺🇸Skokie, Illinois, United States
Willow Rheumatology and Wellness PLLC
🇺🇸Willowbrook, Illinois, United States
Qualmedica Research, LLC
🇺🇸Evansville, Indiana, United States
Alliance for Multispecialty Research, LLC
🇺🇸Wichita, Kansas, United States
Accurate Clinical Research, Inc
🇺🇸Houston, Texas, United States
Klein & Associates, M.D., P.A.
🇺🇸Hagerstown, Maryland, United States
NECCR PrimaCare Research
🇺🇸Fall River, Massachusetts, United States
Advanced Rheumatology, PC
🇺🇸Okemos, Michigan, United States
Saint Paul Rheumatology
🇺🇸Eagan, Minnesota, United States
AARA Clinical Research - Kansas City Physician Partners - North
🇺🇸Kansas City, Missouri, United States
Arthritis Consultants, Inc.
🇺🇸Saint Louis, Missouri, United States
Clinvest Headlands Llc
🇺🇸Springfield, Missouri, United States
Logan Health Research
🇺🇸Kalispell, Montana, United States
Physician Research Collaboration, LLC
🇺🇸Lincoln, Nebraska, United States
Albuquerque Center for Rheumatology
🇺🇸Albuquerque, New Mexico, United States
Inspire Santa Fe Medical Group
🇺🇸Santa Fe, New Mexico, United States
St. Lawrence Health System
🇺🇸Canton, New York, United States
Buffalo Rheumatology and Medicine
🇺🇸Orchard Park, New York, United States
Onsite Clinical Solutions, LLC - Brenner Ave
🇺🇸Salisbury, North Carolina, United States
Paramount Medical Research & Consulting, LLC
🇺🇸Middleburg Heights, Ohio, United States
RAO Research LLC
🇺🇸Oklahoma City, Oklahoma, United States
Essential Medical Research
🇺🇸Tulsa, Oklahoma, United States
Summit Headlands
🇺🇸Portland, Oregon, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
AARA Clinical Research - Murfreesboro Medical Clinic
🇺🇸Murfreesboro, Tennessee, United States
Tekton Research, LLC.
🇺🇸Austin, Texas, United States
Accurate Clinical Management, LLC
🇺🇸Baytown, Texas, United States
Precision Comprehensive Clinical Research Solutions - Colleyville
🇺🇸Colleyville, Texas, United States
Arthritis Care of Texas
🇺🇸Corpus Christi, Texas, United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth
🇺🇸Fort Worth, Texas, United States
Research Physicians Network, LLC
🇺🇸Houston, Texas, United States
AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving
🇺🇸Irving, Texas, United States
Biopharma Informatic, LLC
🇺🇸Katy, Texas, United States
West Texas Clinical Research
🇺🇸Lubbock, Texas, United States
Valley Arthritis Center
🇺🇸McAllen, Texas, United States
SouthWest Rheumatology Research, LLC
🇺🇸Mesquite, Texas, United States
Trinity Universal Research Associates
🇺🇸Plano, Texas, United States
Advanced Rheumatology of Houston - Woodlands
🇺🇸The Woodlands, Texas, United States
DM Clinical Research - TRA
🇺🇸Tomball, Texas, United States
Overlake Arthritis and Osteoporosis Center
🇺🇸Bellevue, Washington, United States
Arthritis Northwest, PLLC
🇺🇸Spokane, Washington, United States
Rheumatology & Pulmonary Clinic
🇺🇸Beckley, West Virginia, United States
Centro Reumatologico Caguas
🇵🇷Caguas, Puerto Rico
Reuviva Research Center
🇵🇷Guaynabo, Puerto Rico
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
Caribbean Medical Research Center
🇵🇷San Juan, Puerto Rico
Mindful Medical Research
🇵🇷San Juan, Puerto Rico