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RecruitingPhase 2

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

Spyre Therapeutics, Inc. · NCT07012395

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
645
US sites recruiting
26
Study start
May 27, 2025
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: SPY001; SPY002; SPY003; Placebo

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • SKYLINE-UC Trial Center · 1-650-402-4238 · info@skyline-uc.com
A Study of Long-acting Antibodies Alone and in Combinations for… (NCT07012395) | Bored Studies