Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT04987307. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in the opinion of the investigator, they may benefit from continued treatment. During the long-term period, participants randomized to efavaleukin alfa will remain on the same efavaleukin alfa blinded dose; participants randomized to placebo who achieved clinical response at week 12 will remain on placebo; and placebo non-responders (ie, participants randomized to placebo who did not achieve clinical response at week 12) will receive efavaleukin alfa in a blinded manner during continued treatment. All participants will complete a safety follow-up visit 6 weeks after their last dose of investigational product.
Study identification
- NCT ID
- NCT04987307
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 221 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2022 (Actual)
- Primary completion
- Oct 22, 2024 (Actual)
- Completion
- Oct 22, 2024 (Actual)
- Last update posted
- Jan 13, 2026
2022 – 2024
United States locations
- U.S. sites
- 63
- U.S. states
- 27
- U.S. cities
- 60
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Birmingham Digestive Health Research, LLC | Homewood | Alabama | 35209 | — |
| Arizona Health Research | Mesa | Arizona | 85206 | — |
| Arizona Arthritis and Rheumatology Research, PLLC | Phoenix | Arizona | 85037 | — |
| Southern California Research Center | Coronado | California | 92118 | — |
| United Medical Doctors | Los Alamitos | California | 90720 | — |
| Biopharma Informatic Incorporated | Los Angeles | California | 90035 | — |
| Gastrointestinal Biosciences Clinical Trials Limited Liability Company | Los Angeles | California | 90067 | — |
| University of California Irvine | Orange | California | 92868 | — |
| Santa Maria Gastroenterology Medical Group | Santa Maria | California | 93458 | — |
| Clinical Trials Management Services LLC | Thousand Oaks | California | 91360 | — |
| Gastroenterology Center of Connecticut, PC | Hamden | Connecticut | 06518 | — |
| West Central Gastroenterology | Clearwater | Florida | 33756 | — |
| Homestead Associates In Research Inc | Homestead | Florida | 33032 | — |
| Indian Health Service Health Research | Kissimmee | Florida | 34741 | — |
| Lake Center for Clinical Research | Lady Lake | Florida | 32159 | — |
| Auzmer Research | Lakeland | Florida | 33813 | — |
| University of Miami Hospital and Clinic | Miami | Florida | 33136 | — |
| Ocala Gastrointestinal Research, LLC | Ocala | Florida | 34471 | — |
| AdventHealth Medical Group Gastroenterology and Hepatology | Orlando | Florida | 32804 | — |
| Infigo Clinical Research | Sanford | Florida | 32771 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Columbus Regional Research Institute, LLC | Columbus | Georgia | 31901 | — |
| Grand Teton Research Group | Idaho Falls | Idaho | 83404 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Digestive Research Alliance of Michiana | South Bend | Indiana | 46635 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Mid-Atlantic GI Research, LLC | Greenbelt | Maryland | 20770 | — |
| Harvard Medical School - Brigham and Womens Hospital | Boston | Massachusetts | 02115 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan | Troy | Michigan | 48098 | — |
| West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | — |
| Southern Therapy and Advanced Research LLC - Jackson | Jackson | Mississippi | 39216 | — |
| Gastrointestinal Associates Research, LLC | Columbia | Missouri | 65201 | — |
| Bvl Clinical Research | Liberty | Missouri | 64068 | — |
| Interspond - Las Vegas Medical Research | Las Vegas | Nevada | 89113 | — |
| Sanmora Bespoke Clinical Research Solutions | East Orange | New Jersey | 07018 | — |
| Aga Clinical Research Associates LLC | Egg Harbor | New Jersey | 08234 | — |
| Affiliates in Gastroenterology Digestive Disease Research | Florham Park | New Jersey | 07932 | — |
| Atlantic Digestive Health Institute | Morristown | New Jersey | 07960 | — |
| Premier Health Research LLC | Sparta | New Jersey | 07871 | — |
| University of New Mexico | Albuquerque | New Mexico | 87106 | — |
| New York University Grossman School of Medicine and New York University Langone Hospitals | Lake Success | New York | 11042 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | — |
| Digestive Specialists Inc Research, LLC | Springboro | Ohio | 45066 | — |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | — |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | — |
| Guthrie Robert Packer Hospital | Sayre | Pennsylvania | 18840 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Columbia Digestive Health Research LLC | Columbia | South Carolina | 29204 | — |
| Wake Research-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Digestive Health Research, LLC | Hermitage | Tennessee | 37076 | — |
| Great Lakes Research Insititute El Paso Research | El Paso | Texas | 79912 | — |
| Digestive Health Associates | Houston | Texas | 77024 | — |
| Digestive Research of Central Texas, LLC | Waco | Texas | 76712 | — |
| Digestive Health Research of North Texas LLC | Wichita Falls | Texas | 76301 | — |
| Emeritas Research Group | Lansdowne Town Center | Virginia | 20176 | — |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | — |
| North Richmond Health Research | Richmond | Virginia | 23229 | — |
| GI Select Health Research LLC | Richmond | Virginia | 23236 | — |
| Hunter Holmes McGuire Veterans Affairs Medical Center | Richmond | Virginia | 23249 | — |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 137 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04987307, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 13, 2026 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04987307 live on ClinicalTrials.gov.