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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-MC-RHDD | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.
The study will last up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide | Experimental | Participants will continue to receive ixekizumab and take tirzepatide subcutaneously (SC) as per label. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1) | The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life. | 12 months |
| Percentage of Participants Achieving at least 10% Weight Reduction | Percentage of participants achieving at least 10% weight reduction. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Body Surface Area (BSA) ≤1 % [National Psoriasis Foundation (NPF) treat to target] | The BSA is the arithmetic mean of the affected skin surface based on the assumption that the head represents 10%, upper extremities represent 20%, trunk represents 30%, and lower extremities represent 40% of the total body surface. The BSA is calculated through multiplying the affected BSA in the head, upper extremities, trunk, and lower extremities by the respective total BSA previously indicated and summing together the scores of each body area. |
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Inclusion Criteria:
Exclusion Criteria:
Other exclusions
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists | Recruiting | Phoenix | Arizona | 85006 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| Month 6 and Month 12 |
| Percentage of Participants Achieving BSA ≤3% (NPF acceptable goal) | The BSA is the arithmetic mean of the affected skin surface based on the assumption that the head represents 10%, upper extremities represent 20%, trunk represents 30%, and lower extremities represent 40% of the total body surface. The BSA is calculated through multiplying the affected BSA in the head, upper extremities, trunk, and lower extremities by the respective total BSA previously indicated and summing together the scores of each body area. | Month 6 and Month 12 |
| Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) (0,1) | The sPGA is an investigator-administered multi-item scale. It determines the participant's psoriasis (PsO) lesions, overall, at a given time point. Overall lesions are graded for plaque elevation, scaling, and erythema, on a range of clear (0), almost clear (1), mild (2), moderate (3), and severe (4). | Month 6 and Month 12 |
| Percentage of Participants Achieving DLQI ≤5 | The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life. | Month 6 and Month 12 |
| Percentage of Participants Achieving Patient Global Assessment (PatGA) Score ≤2 | The PatGA of Psoriasis is a patient-reported single-item scale. Patient Global Assessments allow for an overall evaluation of disease severity or global impact of the disease from the patient's perspective. Participants are asked to rank the severity of their PsO "today" by selecting a number on a 0-to-5 numeric rating scale, with 0 indicating clear/no PsO and 5 indicating severe PsO. | Month 6 and Month 12 |
| Mean Percent Change of Weight from Baseline | Mean percent change of weight from baseline. | Baseline, Month 6 and Baseline, Month 12 |
| Percentage of Participants Achieving DLQI Score (0,1) and Least 10% Weight Reduction | The DLQI is a simple, patient-reported, 10-item, validated, quality of life questionnaire. Scores range from 0 to 30, with higher scores indicating greater impairment of quality of life. | Month 6 and Month 12 |
| First OC Dermatology Research Inc | Recruiting | Fountain Valley | California | 92708 | United States |
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| Center For Dermatology Clinical Research, Inc. | Recruiting | Fremont | California | 94538 | United States |
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| Metropolis Dermatology | Recruiting | Los Angeles | California | 90017 | United States |
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| Northridge Clinical Trials | Recruiting | Northridge | California | 91325 | United States |
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| NeoClinical Research | Recruiting | Hialeah | Florida | 33016 | United States |
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| Skin Care Research | Recruiting | Hollywood | Florida | 33021 | United States |
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| Encore Medical Research | Recruiting | Hollywood | Florida | 33024 | United States |
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| MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research | Recruiting | Tampa | Florida | 33607 | United States |
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| TruDerm & TruSpa | Recruiting | Wellington | Florida | 33449 | United States |
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| Southeast Research Specialists | Recruiting | Douglasville | Georgia | 30135 | United States |
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| Dawes Fretzin Clinical Research Group, LLC | Recruiting | Indianapolis | Indiana | 46250 | United States |
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| The Indiana Clinical Trials Center, PC | Recruiting | Plainfield | Indiana | 46168 | United States |
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| Equity Medical - Bowling Green | Recruiting | Bowling Green | Kentucky | 42104 | United States |
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| Dermatology and Skin Cancer Specialists, LLC | Recruiting | Rockville | Maryland | 20850 | United States |
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| Metro Boston Clinical Partners | Recruiting | Brighton | Massachusetts | 02135 | United States |
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| David Fivenson, MD, PLC | Recruiting | Ann Arbor | Michigan | 48103 | United States |
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| Great Lakes Research Group, Inc. | Recruiting | Bay City | Michigan | 48706 | United States |
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| The Derm Institute of West Michigan | Recruiting | Caledonia | Michigan | 49316 | United States |
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| Skin Cancer and Dermatology Institute - Reno | Recruiting | Reno | Nevada | 89509 | United States |
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| Stracskin | Recruiting | Portsmouth | New Hampshire | 03801 | United States |
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| Psoriasis Treatment Center of Central New Jersey | Recruiting | East Windsor | New Jersey | 08520 | United States |
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| Care Access - Hoboken | Recruiting | Hoboken | New Jersey | 07030 | United States |
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| Equity Medical | Recruiting | New York | New York | 10023 | United States |
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| Revival Research Institute, LLC | Recruiting | Cary | North Carolina | 27511 | United States |
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| Onsite Clinical Solutions - Huntersville | Recruiting | Huntersville | North Carolina | 28078 | United States |
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| Optima Research - Boardman | Recruiting | Boardman | Ohio | 44512 | United States |
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| Oregon Dermatology and Research Center | Recruiting | Portland | Oregon | 97210 | United States |
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| Dermatology Associates of Plymouth Meeting | Recruiting | Plymouth Meeting | Pennsylvania | 19462 | United States |
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| Columbia Dermatology & Aesthetics | Recruiting | Columbia | South Carolina | 29212 | United States |
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| DelRicht Research - Thompson's Station | Recruiting | Smyrna | Tennessee | 37167 | United States |
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| Bellaire Dermatology Associates | Recruiting | Bellaire | Texas | 77401 | United States |
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| Modern Research Associates, PLLC | Recruiting | Dallas | Texas | 75231 | United States |
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| Center for Clinical Studies | Recruiting | Houston | Texas | 77004 | United States |
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| Austin Institute for Clinical Research | Recruiting | Pflugerville | Texas | 78660 | United States |
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| Texas Dermatology and Laser Specialists | Recruiting | San Antonio | Texas | 78218 | United States |
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| Center for Clinical Studies | Recruiting | Webster | Texas | 77598 | United States |
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| Tanner Clinic | Recruiting | Layton | Utah | 84041 | United States |
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| Bellevue Dermatology Clinic | Recruiting | Bellevue | Washington | 98104 | United States |
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| Dermatology of Seattle | Recruiting | Burien | Washington | 98168 | United States |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| 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 |
|---|---|
| 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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