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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524640-35-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPY001 Dosing Regimen 1 | Experimental | Participants will receive SPY001 |
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| SPY002 Dosing Regimen 1 | Experimental | Participants will receive SPY002 |
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| SPY003 Dosing Regimen 1 | Experimental | Participants will receive SPY003 |
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| SPY001 Dosing Regimen 2 | Experimental | Participants will receive SPY001 |
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| SPY002 Dosing Regimen 2 | Experimental | Participants will receive SPY002 |
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| SPY003 Dosing Regimen 2 | Experimental | Participants will receive SPY003 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPY001 | Drug | Experimental |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who experienced an adverse event | Incidence of treatment-emergent adverse events (TEAEs) as measured over time. | Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 48 |
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Inclusion Criteria:
Participants must meet 1 of the following criteria from Study SPY123-201:
Exclusion Criteria:
Met any treatment discontinuation criteria from Study SPY123-201.
Is on any of the following prohibited medications:
Development of any new, unstable, or uncontrolled metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological (including current and past neurological symptoms suggestive of demyelinating disease), respiratory, endocrine, or psychiatric disorder, acute or chronic infectious diseases, suspected or confirmed immunodeficiency, and suspected or confirmed malignancies, as determined by the Investigator that is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.
Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.
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| Name | Affiliation | Role |
|---|---|---|
| SKYLINE Study Director | Spyre Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 002 | San Antonio | Texas | 78229 | United States | ||
| Site 584 |
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| SPY001 & SPY002 |
| Experimental |
Participants will receive SPY001 and SPY002 |
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| SPY001 & SPY003 | Experimental | Participants will receive SPY001 and SPY003 |
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| SPY002 & SPY003 | Experimental | Participants will receive SPY002 and SPY003 |
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| SPY002 Dosing Regimen 3 | Experimental | Participants will receive SPY002 |
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| SPY002 | Drug | Experimental |
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| SPY003 | Drug | Experimental |
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| Kutaisi |
| 4600 |
| Georgia |
| Site 586 | Tbilisi | 0144 | Georgia |
| Site 353 | Wŏnju | Gangwon-do | 26426 | South Korea |
| Site 356 | Seoul | 03312 | South Korea |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D003092 | Colitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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