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NCT03695185 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
A Phase 2 study of Ulcerative Colitis (UC), sponsored by AbbVie.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 20
- Study locations
NCT03695185: Completed Phase 2 study of Ulcerative Colitis (UC), sponsored by AbbVie.
NCT03695185 is a Phase 2 study of Ulcerative Colitis (UC) that has completed, run by AbbVie. The registered enrollment target is 42 participants, below the 762-participant average among 17 other Ulcerative Colitis (UC) trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03695185, a Phase 2 study of Ulcerative Colitis (UC), has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
Primary Outcome
Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, roundi
Conditions Studied
Interventions
- DRUG Ravagalimab 600 mg
- DRUG Ravagalimab 300 mg
Study Locations (20)
California
- Meridian Investigator Network /ID# 204646 - Huntington Beach
- Meridian Investigator Network /ID# 218568 - Lakewood
- TLC Clinical Research Inc /ID# 206626 - Los Angeles
- Orange County Institute of Gastroenterology and Endoscopy /ID# 207405 - Mission Viejo
- UC Davis Medical Center /ID# 209402 - Sacramento
Illinois
- The University of Chicago DCAM /ID# 207086 - Chicago
- Affinity Clinical Research /ID# 206211 - Oak Brook
Arizona
- Banner University Medical Cent /ID# 208392 - Tucson
New Mexico
- Univ New Mexico /ID# 208817 - Albuquerque
Pennsylvania
- Penn Presbyterian Medical Center /ID# 206826 - Philadelphia
Tennessee
- Vanderbilt University Medical Center /ID# 204670 - Nashville
Texas
- Clinical Associates in Research Therapeutics of America, LLC /ID# 204689 - San Antonio
Ontario
- Mount Sinai Hospital /ID# 206180 - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2022-01-10 |
| Phase | Phase 2 |
What the finished NCT03695185 record still lists
NCT03695185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 762-participant average among 17 other Ulcerative Colitis (UC) trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Ulcerative Colitis (UC) appearing as the primary indexed condition, and to 2 interventions - of which Ravagalimab 600 mg is the first listed.
NCT03695185 names 20 study sites across 15 states, led by California, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT03695185 about?
NCT03695185 is a clinical study titled "A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy". Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
What is the current status of trial NCT03695185?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2019-03-26. Estimated completion is 2022-01-10.
What conditions does trial NCT03695185 study?
This clinical trial studies the following conditions: Ulcerative Colitis (UC).
What interventions are being tested in trial NCT03695185?
The interventions under investigation include: Ravagalimab 600 mg (DRUG), Ravagalimab 300 mg (DRUG).
Who is sponsoring clinical trial NCT03695185?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03695185 being conducted?
This trial has 20 study locations across Arizona, California, Illinois, New Mexico, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03695185's enrollment target sits among peer trials
42 15th of 17 higher than 3 of 17 other Ulcerative Colitis (UC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis (UC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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