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

Launched by SPYRE THERAPEUTICS, INC. · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying new treatments for adults with moderate to severe ulcerative colitis (UC), a condition that causes ongoing inflammation in the digestive tract. The main goal is to evaluate how effective and safe these treatments are when given through an intravenous (IV) method initially and then through injections under the skin (subcutaneous) for ongoing care. The trial is currently looking for participants who have been diagnosed with UC for at least three months and who have specific signs of moderate to severe disease activity.

To be eligible for this study, participants should have active UC that affects a certain length of the colon and meet other health criteria. Those who have other types of inflammatory bowel diseases or severe complications that may require surgery are not eligible. If someone joins the study, they can expect thorough monitoring and care during the treatment process, which will help researchers understand how well these new therapies work for managing their condition.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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