Last updated 3 days ago

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

645 patients around the world
Available in Spain, Argentina, United States
This platform study will evaluate the efficacy and safety of investigational treatments, including 3 monotherapies and 3 combination therapies, for moderately to severely active UC in adults. The study will progress in two parts. Part A is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies. Part B, which will be open for enrollment after Part A, is the randomized, placebo-controlled portion of the study assessing the safety and efficacy of the 6 interventions (3 monotherapies and 3 combinations) compared to placebo. Intervention arms will be added to the study over time and may complete at different times.
Spyre Therapeutics, Inc.
645Patients around the world

This study is for people with

Ulcerative colitis

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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.
Trialtech
About usOur missionOur teamPartnersFAQs
Medical newsLatest newsStudiesInterviewsTestimonials
ProductsUEPM OncoUEPM Physicians
LinksDownloadsCareers
LinkedinInstagramFacebook
Terms and ConditionsPrivacy Policy