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NCT07012395 · ClinicalTrials.gov registry record · Phase 2
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
A Phase 2 study of Ulcerative Colitis and Inflammatory Bowel Diseases, sponsored by Spyre Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 645
- Enrollment target
- 20
- Study locations
NCT07012395: Recruiting Phase 2 study of Ulcerative Colitis and Inflammatory Bowel Diseases, sponsored by Spyre Therapeutics.
NCT07012395 is a Phase 2 study of Ulcerative Colitis and Inflammatory Bowel Diseases that is actively recruiting participants, run by Spyre Therapeutics. The registered enrollment target is 645 participants, below the 2,052-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07012395, a Phase 2 study of Ulcerative Colitis and Inflammatory Bowel Diseases, is actively recruiting participants, sponsored by Spyre Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 645 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
Primary Outcome
Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG SPY001
- DRUG SPY002
- DRUG SPY003
Study Locations (20)
Texas
- Site 013 - Cedar Park
- Site 005 - Garland
- Site 002 - San Antonio
- Site 008 - Southlake
- Site 009 - Webster
California
- Site 024 - Canoga Park
- Site 023 - La Jolla
- Site 012 - Lancaster
Florida
- Site 007 - Kissimmee
- 029 - Miami
North Carolina
- 040 - Chapel Hill
- Site 016 - Winston-Salem
Colorado
- Site 033 - Colorado Springs
Kansas
- Site 006 - Kansas City
Louisiana
- Site 035 - Marrero
Maryland
- Site 011 - Glen Burnie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 645 participants |
| Start Date | 2025-05-27 |
| Est. Completion | 2028-03 |
| Phase | Phase 2 |
What NCT07012395 shows while recruiting
NCT07012395 is an interventional study that assigns participants to a tested intervention. The registered 645 participants enrollment target is mid-sized for trials with a published cap, below the 2,052-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (69% lower).
The record links to 4 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT07012395 names 20 study sites across 12 states, led by Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT07012395 about?
NCT07012395 is a clinical study titled "A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis". This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) ma...
What is the current status of trial NCT07012395?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 645 participants. The study started on 2025-05-27. Estimated completion is 2028-03.
What conditions does trial NCT07012395 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Ulcerative, Colitis.
What interventions are being tested in trial NCT07012395?
The interventions under investigation include: Placebo (OTHER), SPY001 (DRUG), SPY002 (DRUG), SPY003 (DRUG).
Who is sponsoring clinical trial NCT07012395?
This trial is sponsored by Spyre Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07012395 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07012395's enrollment target sits among peer trials
645 18th of 122 higher than 105 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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