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A Study of SPY001, SPY002, and SPY003 for Moderate to Severe Ulcerative Colitis

This study is testing new treatments for adults with moderately to severely active ulcerative colitis (UC), a type of inflammatory bowel disease. Researchers are looking at three experimental drugs, SPY001, SPY002, and SPY003, both alone and in combinations. The goal is to see how safe and effective these treatments are. You might be able to join if you are 18 to 75 years old and have had UC for at least three months, confirmed by endoscopy (a procedure using a camera to look inside your body) and histology (studying tissue samples). The study will measure success by looking at changes in your colon tissue and whether your symptoms improve (clinical remission) after 12 weeks. Part A of the study, which is open-label (everyone knows what treatment they are getting), has finished enrolling. Part B, which compares the treatments to a placebo (an inactive substance), started enrolling in April 2026.

Study design
This is a Phase 2, multicenter study with a planned enrollment of 645 participants. It has two parts: an open-label part (Part A) and a randomized, placebo-controlled part (Part B).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07012395

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Spyre Therapeutics, Inc.
~645 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:SPY001SPY002SPY003Placebo

At a glance

Recruiting sites
267 of 267 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Change in Robarts Histopathology Index (RHI)
Measured over Week 12
+1 more outcome measured

Conditions

Ulcerative Colitis
Inflammatory Bowel Diseases
Colitis
Colitis, Ulcerative

Explore related trials

Ulcerative Colitis

Where it's being run

267 sites across 83 states
Poland23
Ukraine14
South Korea12
Georgia10
Germany10
São Paulo7
Japan7
Serbia7

Study leadership

  • SKYLINE-UC Study Director · STUDY_DIRECTOR · Spyre Therapeutics

Who to contact

SKYLINE-UC Trial Center
[email protected]
1-650-402-4238
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part A: Change in Robarts Histopathology Index (RHI)Week 12

    Change in Robarts Histopathology Index (RHI) from baseline at Week 12 will be assessed. The RHI is used to quantify and assess histological activity of UC, comprising of scores for inflammatory infiltrates, neutrophils, erosions or ulceration. Scores are assigned to each of these features, with a total ranging from 0 (no disease activity) to 33 (most severe disease activity). Higher score indicates more severe disease.

  • Part B: Percentage of participants with clinical remissionWeek 12

    Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is based on the modified Mayo subscores, which consist of a rectal bleeding subscore (ranging from 0 to 3), stool frequency subscore (ranging from 0 to 3), and endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher scores indicate more severe disease.