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NCT06127043 · ClinicalTrials.gov registry record · Phase 2
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
A Phase 2 study of Ulcerative Colitis, sponsored by AnaptysBio.
- Active
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT06127043: Active Phase 2 study of Ulcerative Colitis, sponsored by AnaptysBio.
NCT06127043 is a Phase 2 study of Ulcerative Colitis that is active but no longer recruiting, run by AnaptysBio. The registered enrollment target is 132 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06127043, a Phase 2 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by AnaptysBio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study Summary
ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
Primary Outcome
The mMS is an endoscopic and clinical scale, which ranges in scores from 0-9, with higher numbers indicating increased disease severity. It is used to assess UC disease activity. It consists of three subscores: RBS, SFS and an endoscopy subscore.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rosnilimab
Study Locations (20)
Florida
- AnaptysBio Investigational Site 10-127 - Brooksville
- AnaptysBio Investigational Site 10-106 - Miami
- AnaptysBio Investigational Site 10-109 - Miami Gardens
- AnaptysBio Investigational Site 10-131 - Orlando
- AnaptysBio Investigational Site 10-123 - Orlando
- AnaptysBio Investigational Site 10-125 - Tampa
California
- AnaptysBio Investigational Site 10-117 - Garden Grove
- AnaptysBio Investigational Site 10-112 - Lancaster
- AnaptysBio Investigational Site 10-129 - Lancaster
- AnaptysBio Investigational Site 10-108 - San Jose
Texas
- AnaptysBio Investigational Site 10-104 - Dallas
- AnaptysBio Investigational Site 10-113 - Garland
Arizona
- AnaptysBio Investigational Site 10-115 - Phoenix
Georgia
- AnaptysBio Investigational Site 10-122 - Atlanta
Illinois
- AnaptysBio Investigational Site 10-124 - Oak Lawn
Nevada
- AnaptysBio Investigational Site 10-118 - Las Vegas
New York
- AnaptysBio Investigational Site 10-133 - Utica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What the registry record for NCT06127043 still lists
NCT06127043 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06127043 names 20 study sites across 11 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT06127043 about?
NCT06127043 is a clinical study titled "A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)". ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
What is the current status of trial NCT06127043?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2023-12-04. Estimated completion is 2026-05.
What conditions does trial NCT06127043 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT06127043?
The interventions under investigation include: Placebo (DRUG), Rosnilimab (DRUG).
Who is sponsoring clinical trial NCT06127043?
This trial is sponsored by AnaptysBio, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06127043 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
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 NCT06127043's enrollment target sits among peer trials
132 54th of 122 higher than 69 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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