This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 (52)
Facility
City
Region
Status
Site 012
Lancaster
California
Site 035
Marrero
Louisiana
Study Site 002
San Antonio
Texas
Site 019
Tacoma
Washington
Site 103
Rosario
Santa Fe Province
Site 206
South Brisbane
Queensland
Site 471
Ghent
Oost-Vlaanderen
Site 531
Brno
Czechia
Site 584
Kutaisi
Georgia
Site 581
Tbilisi
Georgia
Site 588
Tbilisi
Georgia
Site 583
Tbilisi
Georgia
Site 586
Tbilisi
Georgia
Site 582
Tbilisi
Georgia
Site 634
Athens
Greece
Site 651
Budapest
Hungary
Site 672
Negrar
Verona
Site 424
Amman
Jordan
Site 422
Irbid
Jordan
Site 711
Chisinau
Moldova
Site 753
Bydgoszcz
Poland
Site 732
Bydgoszcz
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
Site 734
Wroclaw
Poland
Site 742
Wroclaw
Poland
Site 788
Timișoara
Romania
Site 802
Belgrade
Serbia
Site 801
Zrenjanin
Serbia
Site 823
Bratislava
Slovakia
Site 824
Prešov
Slovakia
Site 353
Wŏnju
Gangwon-do
Site 357
Busan
South Korea
Site 361
Daegu
South Korea
+ 12 more sites — see the full list on the official registry below.
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.
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