A Phase 2 interventional study of SPY001 and SPY002 in Ulcerative Colitis, Inflammatory Bowel Diseases and Colitis, sponsored by Spyre Therapeutics, Inc.. Enrolling by invitation at 100 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Spyre Therapeutics, Inc. · Phase 2, Interventional, and Treatment
Germany, Austria, Brazil, Mexico, Chile, Turkey (Türkiye)
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study) who have completed Part A and are deemed to be receiving clinical benefit, completed Part B, or met escape criteria in Part B. The primary aim of this LTE study is to characterize the long-term safety of various investigational drugs, to offer participants the option to extend treatment if they are clinically benefiting, or if they have not achieved sufficient clinical benefit (particularly placebo insufficient responders), to offer the opportunity to receive investigational drug.
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.
Counted across the registry records on this site, refreshed daily.
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.
Participants must meet 1 of the following criteria from Study SPY123-201:
Exclusion Criteria:
Is on any of the following prohibited medications:
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive SPY001
Drug: SPY001
Participants will receive SPY002
Drug: SPY002
Participants will receive SPY003
Drug: SPY003
Participants will receive SPY001
Drug: SPY001
Participants will receive SPY002
Drug: SPY002
Participants will receive SPY003
Drug: SPY003
Participants will receive SPY001 and SPY002
Drug: SPY001 · Drug: SPY002
Participants will receive SPY001 and SPY003
Drug: SPY001 · Drug: SPY003
Participants will receive SPY002 and SPY003
Drug: SPY002 · Drug: SPY003
Participants will receive SPY002
Drug: SPY002
Experimental
Also known as: SPY001-001
Experimental
Also known as: SPY002-091
Experimental
Also known as: SPY003-207
Percentage of participants who experienced an adverse event
Incidence of treatment-emergent adverse events (TEAEs) as measured over time.
Time frame: Week 96
Percentage of participants with endoscopic improvement
Percentage of participants with endoscopic improvement at Week 48 will be assessed. Endoscopic improvement based on the Mayo endoscopic subscore (ranging from 0 to 3). Higher score indicates more severe disease.
Time frame: Week 48
Plan to share: No
No publications or documents are linked to this record.
Germany, Austria, Brazil, Mexico, Chile, Turkey (Türkiye)
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.