Long-acting antibody treatments alone and in combinations for moderate to severe ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, multicenter platform study enrolls adults with moderately to severely active ulcerative colitis and uses an IV induction followed by subcutaneous maintenance dosing. Part A is an open-label portion to evaluate safety and early signals of efficacy for three monotherapies. Part B is randomized and placebo-controlled and will compare three monotherapies and three combination regimens to placebo, with intervention arms added over time. Primary outcomes focus on efficacy and safety in participants meeting modified Mayo score entry criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Site 024
  Canoga Park, California, United States Recruiting
• Site 023
  La Jolla, California, United States Recruiting
• Site 012
  Lancaster, California, United States Recruiting
• Site 033
  Colorado Springs, Colorado, United States Recruiting
• Site 007
  Kissimmee, Florida, United States Recruiting
• 029
  Miami, Florida, United States Recruiting

+226 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: SKYLINE-UC Trial Center
• Email: info@skyline-uc.com
• Phone: 1-650-402-4238

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.