A Phase 2 interventional study of SPY001 and SPY002 in Ulcerative Colitis, Inflammatory Bowel Diseases and Colitis, sponsored by Spyre Therapeutics, Inc.. Recruiting at 276 sites in 35 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Spyre Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
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 A enrollment completed April 2026.
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. Part B enrollment commenced April 2026.
Intervention arms will be added to the study over time and may complete at different times.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 645 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Spyre Therapeutics, Inc. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive open-label dose of SPY001
Drug: SPY001
Participants will receive open-label dose of SPY002
Drug: SPY002
Participants will receive open-label dose of SPY003
Drug: SPY003
Participants will receive double-blind dosing regimen 1 of SPY001
Drug: SPY001
Participants will receive double-blind dosing regimen 2 of SPY001
Drug: SPY001
Participants will receive double-blind dosing regimen 1 of SPY002
Drug: SPY002
Participants will receive double-blind dosing regimen 2 of SPY002
Drug: SPY002
Participants will receive double-blind dosing regimen 1 of SPY003
Drug: SPY003
Participants will receive double-blind dosing regimen 2 of SPY003
Drug: SPY003
Participants will receive double-blind dose of SPY001 and SPY002
Drug: SPY001 · Drug: SPY002
Participants will receive double-blind dose of SPY001 and SPY003
Drug: SPY001 · Drug: SPY003
Participants will receive double-blind dose of SPY002 and SPY003
Drug: SPY002 · Drug: SPY003
Participants will receive matching placebo
Other: Placebo
Experimental
Also known as: SPY001-001
Experimental
Also known as: SPY002-091
Experimental
Also known as: SPY003-207
Placebo
Part A: Change in Robarts Histopathology Index (RHI)
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.
Time frame: Week 12
Part B: Percentage of participants with clinical remission
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.
Time frame: Week 12
Part A: Percentage of participants with clinical remission
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.
Time frame: Week 12
Part A: Percentage of participants with endoscopic improvement
Percentage of participants with endoscopic improvement at Week 12 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher score indicates more severe disease.
Time frame: Week 12
Part B: Percentage of participants with endoscopic improvement
Percentage of participants with endoscopic improvement at Week 12 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3), as assessed by central reading. Higher score indicates more severe disease.
Time frame: Week 12
Part B: Percentage of participants with clinical response
Percentage of participants with clinical response at Week 12 will be assessed. Clinical response is based on the modified Mayo Score, 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.
Time frame: Week 12
Part B: Percentage of participants with histologic improvement
Percentage of participants with histologic improvement at Week 12 will be assessed. Histologic improvement is based on the Geboes score. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. Higher score indicates more severe disease.
Time frame: Week 12
Part B: Percentage of participants achieving histologic endoscopic mucosal improvement (HEMI).
Percentage of participants with HEMI at Week 12 will be assessed. Mucosal improvement is based on the Mayo endoscopic subscore and the Geboes score. The Mayo endoscopic subscore ranges from 0 to 3, as assessed by central reading. Higher score indicates more severe disease. The Geboes histologic index includes 7 histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades from 0 to 5, with each grade of the score divided into 4 or 5 subcategories; the score ranges from 0.0 to 5.4. Higher score indicates more severe disease
Time frame: Week 12
Part B: Percentage of participants with clinical remission
Percentage of participants with clinical remission at Week 48 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.
Time frame: Week 48
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Spyre Therapeutics, Inc.