Clinical trial NCT07012395: A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Colitis
Colitis, Ulcerative
Lead sponsor: Spyre Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Part A: Change in Robarts Histopathology Index (RHI)
timeFrame: Week 12
Secondary outcomes:
measure: Part A: Percentage of participants with clinical remission
timeFrame: Week 12
measure: Part A: Percentage of participants with endoscopic improvement
timeFrame: Week 12
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Site 012
state: California
city: Winston-Salem
country: United States
facility: Site 016
state: North Carolina
city: Garland
country: United States
facility: Site 005
state: Texas
city: San Antonio
country: United States
facility: Site 002
state: Texas
city: Southlake
country: United States
facility: Site 008
state: Texas
city: Webster
country: United States
facility: Site 009
state: Texas
Study officials:
affiliation: Spyre Therapeutics
name: SKYLINE-UC Study Director
role: STUDY_DIRECTOR
References: