RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-27
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07012395

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening
  2. * 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)
  3. * 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
  1. * Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined
  2. * Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction
  3. * Failed 4 or more approved or investigational advanced therapy classes

Contacts and Locations

Study Contact

SKYLINE-UC Trial Center
CONTACT
1-650-402-4238
info@skyline-uc.com

Principal Investigator

SKYLINE-UC Study Director
STUDY_DIRECTOR
Spyre Therapeutics

Study Locations (Sites)

Site 012
Lancaster, California, 93534
United States
Site 016
Winston-Salem, North Carolina, 27103
United States
Site 005
Garland, Texas, 75246
United States
Site 002
San Antonio, Texas, 78229
United States
Site 008
Southlake, Texas, 76092
United States
Site 009
Webster, Texas, 77598
United States

Collaborators and Investigators

Sponsor: Spyre Therapeutics, Inc.

  • SKYLINE-UC Study Director, STUDY_DIRECTOR, Spyre Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-27
Study Completion Date2027-06

Study Record Updates

Study Start Date2025-05-27
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis
  • Inflammatory Bowel Diseases
  • Colitis
  • Colitis, Ulcerative