Enrolling by invitation
Phase 2
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
Condition(s) studied
Ulcerative ColitisInflammatory Bowel DiseasesColitisColitis, Ulcerative
Investigational drug(s) / intervention(s)
SPY001SPY002SPY003
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 (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.