Testing Long-acting Antibodies Alone and Combined for Ulcerative Colitis
Tests long-acting antibody drugs, alone and combined, in adults with moderate to severe ulcerative colitis.
Plain-language title generated from the registry record
Registry title: A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
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
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07012395, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- National Institute of Gastroenterology Saverio De Bellis Research HospitalCastellana Grotte, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Ovest MilaneseLegnano, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- IRCCS Ospedale Sacro Cuore Don CalabriaNegrar, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people
- Policlinico San Donato S.p.A.San Donato Milanese, ItalyTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
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
- NCT07012395EU 2025-521242-26-00
- Record updated
- 27 October 2026
- Original description
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.Read full original descriptionShow less
Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.
Inclusion: Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening; Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis); Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2.
Exclusion: Failed 4 or more approved or investigational advanced therapy classes; Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined; Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and/or other conditions that will likely require surgery during induction.