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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 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.

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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.

Conditions Studied

Ulcerative Colitis Inflammatory Bowel Diseases Colitis, Ulcerative Colitis

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

FieldValue
Enrollment Target 645 participants
Start Date 2025-05-27
Est. Completion 2028-03
Phase Phase 2

Sponsor

Spyre Therapeutics

6 total trials

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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, categorized as Phase 2. The registered enrollment target is 645 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,052-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (69% lower). The listed sponsor is Spyre Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.