RECRUITING

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

Description

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

Ulcerative ColitisInflammatory Bowel DiseasesColitisColitis, Ulcerative
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Related Conditions:

Ulcerative ColitisInflammatory Bowel DiseasesColitisColitis, Ulcerative

Study Overview

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Study Details

Study overview

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.

Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis

A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Lancaster

Site 012, Lancaster, California, United States, 93534

Winston-Salem

Site 016, Winston-Salem, North Carolina, United States, 27103

Garland

Site 005, Garland, Texas, United States, 75246

San Antonio

Site 002, San Antonio, Texas, United States, 78229

Southlake

Site 008, Southlake, Texas, United States, 76092

Webster

Site 009, Webster, Texas, United States, 77598

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening
  • * Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)
  • * Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2
  • * Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined
  • * Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction
  • * Failed 4 or more approved or investigational advanced therapy classes

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Spyre Therapeutics, Inc.,

SKYLINE-UC Study Director, STUDY_DIRECTOR, Spyre Therapeutics

Study Record Dates

2027-06