Long-term study of long-acting antibodies alone and combined for ulcerative colitis
Tests long-acting antibodies SPY001, SPY002 and SPY003 in adults with ulcerative colitis.
Plain-language title generated from the registry record
Registry title: Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
Key facts
- Where
- Bologna, Castellana Grotte, Legnano, Milan, Negrar, Padova, Pavia, Rome, Rozzano, San Donato Milanese, and Turin, ItalySee the 12 sites
- Phase
- Phase 2
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNot yet recruiting
- National Institute of Gastroenterology Saverio De Bellis Research HospitalCastellana Grotte, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Ovest MilaneseLegnano, ItalyNot yet recruiting
- Ospedale San Raffaele S.r.l.Milan, ItalyNot yet recruiting
- IRCCS Ospedale Sacro Cuore Don CalabriaNegrar, ItalyNot yet recruiting
- Azienda Ospedaliera di PadovaPadova, ItalyNot yet recruiting
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
- Policlinico San Donato S.p.A.San Donato Milanese, ItalyNot yet recruiting
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Spyre Therapeutics, Inc.
- Trial code
- NCT07652294EU 2025-524640-35-00
- Record updated
- 9 November 2026
- Original description
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).Read full original descriptionShow less
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
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
Inclusion: 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: 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; Met any treatment discontinuation criteria from Study SPY123-201.