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The purpose of this study is to determine the effective dose(s) of RPC4046 in the treatment of Eosinophilic Esophagitis (EoE). This trial consists of two phases: 16 weeks of double-blind treatment and 52 weeks of open-label extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPC4046 Low Dose | Experimental | intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose |
|
| RPC4046 High Dose | Experimental | intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose |
|
| Placebo | Placebo Comparator | intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPC4046 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Eosinophil Count | Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic - Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Desert Sun Clinical Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41067281 | Derived | Caldwell JM, Ballaban AY, Li J, Maddux R, Harris S, Dellon ES, Rothenberg ME. Cendakimab (anti-IL-13) administration improves esophageal gene expression in eosinophilic esophagitis. J Allergy Clin Immunol. 2026 Jan;157(1):118-130.e7. doi: 10.1016/j.jaci.2025.08.032. Epub 2025 Oct 9. | |
| 32205221 | Derived | Dellon ES, Collins MH, Rothenberg ME, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer A, Straumann A, Safroneeva E, Rodriguez C, Minton N, Hua SY, Hirano I. Long-term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis. Clin Gastroenterol Hepatol. 2021 Mar;19(3):473-483.e17. doi: 10.1016/j.cgh.2020.03.036. Epub 2020 Mar 21. |
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|
| Tucson |
| Arizona |
| 85710 |
| United States |
| Alliance Clinical Research | Oceanside | California | 92056 | United States |
| Precision Research Institute, LLC | San Diego | California | 92114 | United States |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States |
| Connecticut Clinical Research Foundation | Bristol | Connecticut | 06010 | United States |
| University of Florida | Gainesville | Florida | 32608 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| Children's Center for Digestive Healthcare | Atlanta | Georgia | 30342 | United States |
| Grand Teton Research Group | Idaho Falls | Idaho | 83404 | United States |
| Northwestern University-Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Gastroenterology and Hepatology Service Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Metropolitan Gastroenterology Group Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | United States |
| Minnesota Gastroenterology | Plymouth | Minnesota | 55446 | United States |
| GI Associates and Endoscopy Center-GI Clinical Research Department | Flowood | Mississippi | 39232 | United States |
| Darthmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | 28801 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Great Lakes Gastroenterology Research | Mentor | Ohio | 44060 | United States |
| University of Pennsylvania Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University | Nashville | Tennessee | 37212 | United States |
| University of Utah Division of Gastroenterology | Salt Lake City | Utah | 84132 | United States |
| Gastrointestinal Research Group, University of Calgary Health | Calgary | Alberta | T2N 4Z6 | Canada |
| Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | 1011 | Switzerland |
| Swiss EoE Clinic | Olten | 4600 | Switzerland |
| 30395812 | Derived | Hirano I, Collins MH, Assouline-Dayan Y, Evans L, Gupta S, Schoepfer AM, Straumann A, Safroneeva E, Grimm M, Smith H, Tompkins CA, Woo A, Peach R, Frohna P, Gujrathi S, Penenberg DN, Li C, Opiteck GJ, Olson A, Aranda R, Rothenberg ME, Dellon ES; HEROES Study Group. RPC4046, a Monoclonal Antibody Against IL13, Reduces Histologic and Endoscopic Activity in Patients With Eosinophilic Esophagitis. Gastroenterology. 2019 Feb;156(3):592-603.e10. doi: 10.1053/j.gastro.2018.10.051. Epub 2018 Nov 2. |
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000625155 | cendakimab |
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