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A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
NCT07012395 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07012395
The ClinicalTrials.gov registry entry for NCT07012395 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 645 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spyre Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07012395 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07012395?
The interventions under investigation include: Placebo (OTHER), SPY001 (DRUG), SPY002 (DRUG), SPY003 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07012395?
This trial is sponsored by Spyre Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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