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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-MC-RHDB | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixekizumab | Experimental | Ixekizumab administered subcutaneous (SC). |
|
| Ixekizumab and Tirzepatide | Experimental | Ixekizumab concomitantly administered with tirzepatide SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Simultaneously Achieved American College of Rheumatology (ACR) ACR50 and at Least a 10% Weight Reduction | 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:
| Baseline up to Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Simultaneously Achieving American College of Rheumatology (ACR) ACR20 and at Least a 5% Weight Reduction | 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:
|
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Avondale | Avondale | Arizona | 85392 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41903163 | Derived | Merola JF, Mease P, Kivitz A, Sattar N, Coates LC, Aletaha D, Kartman CE, Fischer P, Sun L, Martinez-Osuna P, Kronbergs A, Prajapati P, Cardoso A, Genovese MC, Ogdie A. Ixekizumab With Tirzepatide Achieved Greater Disease Control Than Ixekizumab Alone in Adults With Psoriatic Arthritis and Overweight or Obesity: Results From a Randomized Clinical Trial. Arthritis Rheumatol. 2026 Mar 28. doi: 10.1002/art.70134. Online ahead of print. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Tirzepatide | Drug | Administered SC |
|
|
| Baseline up to Week 36 |
| Percentage of Participants Achieving ACR50 | 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:
| Baseline up to Week 36 |
| Percentage of Participants Achieving at Least a 10% Weight Reduction | Percentage of Participants Who Achieved at Least a 10% Weight Reduction | Baseline up to Week 36 |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler |
| Chandler |
| Arizona |
| 85225 |
| United States |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff | Flagstaff | Arizona | 86001 | United States |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Gilbert | Gilbert | Arizona | 85297 | United States |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Glendale | Glendale | Arizona | 85306 | United States |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa | Mesa | Arizona | 85210 | United States |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix PV | Phoenix | Arizona | 85032 | United States |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Sun City | Sun City | Arizona | 85351 | United States |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson | Tucson | Arizona | 85704 | United States |
| AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast | Tucson | Arizona | 85748 | United States |
| Medvin Clinical Research - Apple Valley | Apple Valley | California | 92307 | United States |
| Medvin Clinical Research - Covina | Covina | California | 91722 | United States |
| Newport Huntington Medical Group | Huntington Beach | California | 92648 | United States |
| Purushotham & Akther Kotha MD, Inc | La Mesa | California | 91942 | United States |
| Medvin Clinical Research - Riverside | Riverside | California | 92508 | United States |
| Rheumatology Center of San Diego | San Diego | California | 92128 | United States |
| Medvin Clinical Research - Temecula | Temecula | California | 92592 | United States |
| Cohen Medical Centers | Thousand Oaks | California | 91360 | United States |
| Medvin Clinical Research - Tujunga | Tujunga | California | 91042 | United States |
| Medvin Clinical Research - Whittier | Whittier | California | 90602 | United States |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | United States |
| Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | Florida | 33765 | United States |
| NeoClinical Research | Hialeah | Florida | 33016 | United States |
| South Florida Rheumatology | Hollywood | Florida | 33021 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Vida Clinical Research | Kissimmee | Florida | 34741 | United States |
| Life Clinical Trials | Margate | Florida | 33063 | United States |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | United States |
| Vitalia Medical Research | Palm Beach Gardens | Florida | 33410 | United States |
| Sarasota Arthritis Center | Sarasota | Florida | 34239 | United States |
| Clinical Research of West Florida | Tampa | Florida | 33606 | United States |
| International Center for Research | Tampa | Florida | 33614 | United States |
| Conquest Research | Winter Park | Florida | 32789 | United States |
| Southeastern Rheumatology Alliance dba Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | United States |
| Atlanta Research Center for Rheumatology | Marietta | Georgia | 30060 | United States |
| St. Luke's Clinic | Boise | Idaho | 83702 | United States |
| Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois | 60640 | United States |
| Greater Chicago Specialty Physicians | Schaumburg | Illinois | 60195 | United States |
| Arnold Arthritis & Rheumatology | Skokie | Illinois | 60076 | United States |
| Willow Rheumatology and Wellness PLLC | Willowbrook | Illinois | 60527 | United States |
| Qualmedica Research, LLC | Evansville | Indiana | 47715 | United States |
| Alliance for Multispecialty Research, LLC | Wichita | Kansas | 67207 | United States |
| Accurate Clinical Research, Inc | Lake Charles | Louisiana | 70605 | United States |
| Klein & Associates, M.D., P.A. | Cumberland | Maryland | 21502 | United States |
| Klein & Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | United States |
| NECCR PrimaCare Research | Fall River | Massachusetts | 02721 | United States |
| Advanced Rheumatology, PC | Okemos | Michigan | 48864 | United States |
| Saint Paul Rheumatology | Eagan | Minnesota | 55121 | United States |
| AARA Clinical Research - Kansas City Physician Partners - North | Kansas City | Missouri | 64151 | United States |
| Clinvest Headlands Llc | Springfield | Missouri | 65807 | United States |
| Arthritis Consultants, Inc. | St Louis | Missouri | 63141 | United States |
| Logan Health Research | Kalispell | Montana | 59901 | United States |
| Physician Research Collaboration, LLC | Lincoln | Nebraska | 68516 | United States |
| Albuquerque Center for Rheumatology | Albuquerque | New Mexico | 87102 | United States |
| Inspire Santa Fe Medical Group | Santa Fe | New Mexico | 87505 | United States |
| St. Lawrence Health System | Canton | New York | 13617 | United States |
| Onsite Clinical Solutions, LLC - Brenner Ave | Salisbury | North Carolina | 28144 | United States |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | 44130 | United States |
| RAO Research LLC | Oklahoma City | Oklahoma | 73116 | United States |
| Essential Medical Research | Tulsa | Oklahoma | 74137 | United States |
| Summit Headlands | Portland | Oregon | 97210 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| AARA Clinical Research - Murfreesboro Medical Clinic | Murfreesboro | Tennessee | 37128 | United States |
| Tekton Research, LLC. | Austin | Texas | 78745 | United States |
| Accurate Clinical Management, LLC | Baytown | Texas | 77521 | United States |
| Precision Comprehensive Clinical Research Solutions - Colleyville | Colleyville | Texas | 76034 | United States |
| Arthritis Care of Texas | Corpus Christi | Texas | 78415 | United States |
| AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Fort Worth | Fort Worth | Texas | 76109 | United States |
| Accurate Clinical Research, Inc | Houston | Texas | 77089 | United States |
| Research Physicians Network, LLC | Houston | Texas | 77089 | United States |
| AARA Clinical Research - Lone Star Arthritis and Rheumatology Associates - Irving | Irving | Texas | 75039 | United States |
| Biopharma Informatic, LLC | Katy | Texas | 77494 | United States |
| West Texas Clinical Research | Lubbock | Texas | 79424 | United States |
| Valley Arthritis Center | McAllen | Texas | 78501 | United States |
| SouthWest Rheumatology Research, LLC | Mesquite | Texas | 75150 | United States |
| Advanced Rheumatology of Houston - Woodlands | The Woodlands | Texas | 77382 | United States |
| DM Clinical Research - TRA | Tomball | Texas | 77375 | United States |
| Overlake Arthritis and Osteoporosis Center | Bellevue | Washington | 98004 | United States |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | United States |
| Rheumatology & Pulmonary Clinic | Beckley | West Virginia | 25801 | United States |
| Centro Reumatologico Caguas | Caguas | 00725 | Puerto Rico |
| Reuviva Research Center | Guaynabo | 00968 | Puerto Rico |
| GCM Medical Group, PSC - Hato Rey Site | San Juan | 00917 | Puerto Rico |
| Caribbean Medical Research Center | San Juan | 00918 | Puerto Rico |
| Mindful Medical Research | San Juan | 00918 | Puerto Rico |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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