Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis
Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT02098473
Collaborator
(none)
100
30
3
29
3.3
0.1
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis
Actual Study Start Date
:
Aug 31, 2014
Actual Primary Completion Date
:
Feb 17, 2016
Actual Study Completion Date
:
Jan 30, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: RPC4046 Low Dose intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, low dose |
Drug: RPC4046
|
| Experimental: RPC4046 High Dose intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks, high dose |
Drug: RPC4046
|
| Placebo Comparator: Placebo intravenous (IV) infusion only once at first dose, 2 subcutaneous (SC) injections weekly for 16 weeks |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Mean Eosinophil Count [Week 16]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologic evidence of EoE
-
Clinical symptoms of EoE including dysphagia
Exclusion Criteria:
- Primary causes of esophageal eosinophilia other than EoE
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic - Arizona | Scottsdale | Arizona | United States | 85259 |
| 2 | Desert Sun Clinical Research, LLC | Tucson | Arizona | United States | 85710 |
| 3 | Alliance Clinical Research | Oceanside | California | United States | 92056 |
| 4 | Precision Research Institute, LLC | San Diego | California | United States | 92114 |
| 5 | University of Colorado School of Medicine | Aurora | Colorado | United States | 80045 |
| 6 | Connecticut Clinical Research Foundation | Bristol | Connecticut | United States | 06010 |
| 7 | University of Florida | Gainesville | Florida | United States | 32608 |
| 8 | Borland-Groover Clinic | Jacksonville | Florida | United States | 32256 |
| 9 | Children's Center for Digestive Healthcare | Atlanta | Georgia | United States | 30342 |
| 10 | Grand Teton Research Group | Idaho Falls | Idaho | United States | 83404 |
| 11 | Northwestern University-Feinberg School of Medicine | Chicago | Illinois | United States | 60611 |
| 12 | Southwest Gastroenterology | Oak Lawn | Illinois | United States | 60453 |
| 13 | Indiana University | Indianapolis | Indiana | United States | 46202 |
| 14 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 15 | Gastroenterology and Hepatology Service Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20889 |
| 16 | Metropolitan Gastroenterology Group Chevy Chase Clinical Research | Chevy Chase | Maryland | United States | 20815 |
| 17 | West Michigan Clinical Research Center Gastroenterology Associates of Western Michigan | Wyoming | Michigan | United States | 49519 |
| 18 | Minnesota Gastroenterology | Plymouth | Minnesota | United States | 55446 |
| 19 | GI Associates and Endoscopy Center-GI Clinical Research Department | Flowood | Mississippi | United States | 39232 |
| 20 | Darthmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 21 | Asheville Gastroenterology Associates, PA | Asheville | North Carolina | United States | 28801 |
| 22 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 23 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
| 24 | Great Lakes Gastroenterology Research | Mentor | Ohio | United States | 44060 |
| 25 | University of Pennsylvania Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | United States | 19104 |
| 26 | Vanderbilt University | Nashville | Tennessee | United States | 37212 |
| 27 | University of Utah Division of Gastroenterology | Salt Lake City | Utah | United States | 84132 |
| 28 | Gastrointestinal Research Group, University of Calgary Health | Calgary | Alberta | Canada | T2N 4Z6 |
| 29 | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Switzerland | 1011 | |
| 30 | Swiss EoE Clinic | Olten | Switzerland | 4600 |
Sponsors and Collaborators
- Celgene
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Celgene
ClinicalTrials.gov Identifier:
NCT02098473
Other Study ID Numbers:
- RPC02-201
First Posted:
Mar 28, 2014
Last Update Posted:
May 9, 2017
Last Verified:
May 1, 2017