NCT07012395Phase 2Recruiting

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

Study sponsor: Spyre Therapeutics, Inc. · SYRE

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-06Estimated

Enrollment · participants645Estimated

Source updated2026-08-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-16 · 1 field changed

Primary completion date

Recorded edit

− Previous value

2026-06

+ Updated value

2027-06

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Study details

Conditions studied

Ulcerative Colitis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative

Treatments or interventions studied

SPY001DrugAlso known as SPY001-001
SPY002DrugAlso known as SPY002-091
SPY003DrugAlso known as SPY003-207

Primary outcomes · main study measures

Read the study measures

measure: Part A: Change in Robarts Histopathology Index (RHI); description: 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.; timeFrame: Week 12; measure: Part B: Percentage of participants with clinical remission; description: 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.; timeFrame: Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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