Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPY001, SPY002, SPY003.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Czechia, Georgia, Greece, Poland +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study to Evaluate the Long-term Safety and Efficacy of Long-acting Antibodies as Single Agents and in Combinations in Participants With Inflammatory Bowel Disease
Overview
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Detailed description
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.
Interventions
- Drug SPY001
Experimental - Drug SPY002
Experimental - Drug SPY003
Experimental
Primary outcome measures
- Percentage of participants who experienced an adverse event [Time frame: Week 96]
Secondary outcome measures (1)
- Percentage of participants with endoscopic improvement [Time frame: Week 48]
Eligibility criteria
Inclusion criteria
Participants must meet 1 of the following criteria from Study SPY123-201:
- Completed Part A and deemed to be receiving clinical benefit by the judgement of the Investigator
- Completed Part B
- 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
- Met any treatment discontinuation criteria from Study SPY123-201.
- Is on any of the following prohibited medications:
- Immunosuppressants (eg, azathioprine, 6-mercaptopurine \[6-MP\], or methotrexate)
- 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
- Any marketed advanced therapy (ie, biologic or small molecule)
- Any investigational therapy other than SPY123-201 study drug
- Total parenteral nutrition
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Poland · 5 centers
- Site 736 — Rzeszów
- Site 752 — Tychy
- Site 754 — Warsaw
- Site 731 — Warsaw
- Site 738 — Wroclaw
Georgia · 3 centers
- Site 584 — Kutaisi
- Site 583 — Tbilisi
- Site 586 — Tbilisi
South Korea · 2 centers
- Site 353 — Wŏnju
- Site 356 — Seoul
United States · 1 center
- Study Site 002 — San Antonio
Czechia · 1 center
- Site 531 — Brno
Greece · 1 center
- Site 634 — Athens
Serbia · 1 center
- Site 802 — Belgrade
Taiwan · 1 center
- Site 396 — Taichung
Identifiers
NCT: NCT07652294 · SPY123-202 · 2025-524640-35-00