Clinical Trials in South Korea / NCT07652294
Enrolling by invitation
Phase 2
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
NCT07652294 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Ulcerative ColitisInflammatory Bowel DiseasesColitisColitis, Ulcerative
Investigational drug(s) / intervention(s)
SPY001: Experimental
SPY002: Experimental
SPY003: Experimental
Study summary
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Eligibility
Inclusion Criteria:
Participants must meet 1 of the following criteria from Study SPY123-201:
1. Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
2. Completed Part B
3. Participated in Part B and met escape criteria per the SPY123-201 protocol (ie, did not achieve sufficient improvement after the induction treatment period \[ITP\] or experienced disease worsening during the maintenance treatment period \[MTP\]).
Exclusion Criteria:
1. Met any treatment discontinuation criteria from Study SPY123-201.
2. Is on any of the following prohibited medications:
1. Immunosuppressants (eg, azathioprine, 6-mercaptopurine \[6-MP\], or methotrexate)
2. Systemic tacrolimus, systemic cyclosporine, oral mycophenolate mofetil (MMF), immunoadsorption columns (such as Prosorba columns), penicillamine, leflunomide, thalidomide, or any other medications that may have immunosuppressive effects
3. Any marketed advanced therapy (ie, biologic or small molecule)
4. Any investigational therapy other than SPY123-201 study drug
5. Total parenteral nutrition
3. 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.
4. Ongoing infection requiring oral or intravenous antimicrobial therapy on Day 1.
Primary outcome measure(s)
- Percentage of participants who experienced an adverse event — Week 96
Incidence of treatment-emergent adverse events (TEAEs) as measured over time.
Trial sites (70)
| Facility | City | Region | Status |
|---|---|---|---|
| Site 012 | Lancaster | California | |
| Site 007 | Kissimmee | Florida | |
| Site 035 | Marrero | Louisiana | |
| Site 025 | Providence | Rhode Island | |
| Study Site 002 | San Antonio | Texas | |
| Site 019 | Tacoma | Washington | |
| Site 103 | Rosario | Santa Fe Province | |
| Site 208 | Concord | New South Wales | |
| Site 206 | South Brisbane | Queensland | |
| Site 471 | Ghent | Oost-Vlaanderen | |
| Site 531 | Brno | Czechia | |
| Site 584 | Kutaisi | Georgia | |
| Site 589 | Marneuli | Georgia | |
| Site 581 | Tbilisi | Georgia | |
| Site 588 | Tbilisi | Georgia | |
| Site 583 | Tbilisi | Georgia | |
| Site 586 | Tbilisi | Georgia | |
| Site 582 | Tbilisi | Georgia | |
| Site 587 | Tbilisi | Georgia | |
| Site 603 | Ulm | Germany | |
| Site 634 | Athens | Greece | |
| Site 651 | Budapest | Hungary | |
| Site 652 | Székesfehérvár | Hungary | |
| Site 672 | Negrar | Verona | |
| Site 424 | Amman | Jordan | |
| Site 422 | Irbid | Jordan | |
| Site 423 | Irbid | Jordan | |
| Site 711 | Chisinau | Moldova | |
| Site 753 | Bydgoszcz | Poland | |
| Site 732 | Bydgoszcz | Poland | |
| Site 750 | Kłodzko | Poland | |
| Site 743 | Opole | Poland | |
| Site 740 | Poznan | Poland | |
| Site 736 | Rzeszów | Poland | |
| Site 744 | Sopot | Poland | |
| Site 737 | Szczecin | Poland | |
| Site 752 | Tychy | Poland | |
| Site 754 | Warsaw | Poland | |
| Site 731 | Warsaw | Poland | |
| Site 738 | Wroclaw | Poland |
+ 30 more sites — see the full list on the official registry below.
More Spyre Therapeutics, Inc. trials in South Korea
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07652294 on ClinicalTrials.gov ↗ ← All trials in South Korea