Under construction – not a live service
Sign in
Taking people in BulgariaPhase 2

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.

Key facts

Who runs it
Spyre Therapeutics, Inc.
Where
Gorna Oryahovitsa, Ruse, Sofia, and Sofiya, BulgariaSee the 8 sitesAlso in 35 other countries, 288 sites
Trial code
Registry title
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
Status
Recruiting
Phase
Phase 2
People taking part
645 people, planned
Started
27 May 2025
Expected to end
Mar 2028
Type of study
Interventional, 13 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • SPY001
  • SPY002
  • SPY003
  • Placebo
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with moderately to severely active ulcerative colitis, confirmed by endoscopy.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Ulcerative colitis diagnosed at least 3 months before Day 1, confirmed by endoscopy and histology. Disease must be moderately to severely active: modified Mayo score of 5-9, rectal bleeding subscore of 1 or more, and Mayo endoscopic subscore of 2 or more. Disease must reach 15 cm (5.9 in) or more from the anal verge, though up to about 15% may have only proctitis.
Earlier treatment
People who failed 4 or more approved or investigational advanced therapy classes cannot join.

Main reasons for not taking part

  • Current diagnosis of Crohn's disease or IBD-Undefined
  • Confirmed or suspected fulminant colitis, toxic megacolon or bowel perforation
  • Other conditions likely to need surgery during induction
  • Failed 4 or more advanced therapy classes

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Bulgaria

Also in 35 other countries, 288 sites

  • Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOODGorna Oryahovitsa, BulgariaTaking people
  • The medical centre Kanev Ltd.Ruse, BulgariaTaking people
  • Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOODSofia, BulgariaTaking people
  • Medical center Orange Ltd.Sofia, BulgariaTaking people
  • National Multidisciplinary Transport Hospital Tsar Boris IIISofia, BulgariaTaking people
  • Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EADSofia, BulgariaTaking people
  • Dkc Fokus-5 Lzip OODSofiya, BulgariaTaking people
  • Multiprofile Hospital For Active Treatment Vita Ltd.Sofiya, BulgariaTaking people

About the trial

What the trial wants to find out

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.

The 13 groups in the trial

  • Intervention Specific Appendix - SPY001: Part ATreatment being tested

    Participants will receive open-label dose of SPY001

    Treatment: SPY001

  • Intervention Specific Appendix - SPY002: Part ATreatment being tested

    Participants will receive open-label dose of SPY002

    Treatment: SPY002

  • Intervention Specific Appendix - SPY003: Part ATreatment being tested

    Participants will receive open-label dose of SPY003

    Treatment: SPY003

  • Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part BTreatment being tested

    Participants will receive double-blind dosing regimen 1 of SPY001

    Treatment: SPY001

  • Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part BTreatment being tested

    Participants will receive double-blind dosing regimen 2 of SPY001

    Treatment: SPY001

  • Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part BTreatment being tested

    Participants will receive double-blind dosing regimen 1 of SPY002

    Treatment: SPY002

  • Intervention Specific Appendix - SPY002 Dosing Regimen 2: Part BTreatment being tested

    Participants will receive double-blind dosing regimen 2 of SPY002

    Treatment: SPY002

  • Intervention Specific Appendix - SPY003 Dosing Regimen 1: Part BTreatment being tested

    Participants will receive double-blind dosing regimen 1 of SPY003

    Treatment: SPY003

  • Intervention Specific Appendix - SPY003 Dosing Regimen 2: Part BTreatment being tested

    Participants will receive double-blind dosing regimen 2 of SPY003

    Treatment: SPY003

  • Intervention Specific Appendix - SPY120: Part BTreatment being tested

    Participants will receive double-blind dose of SPY001 and SPY002

    Treatment: SPY001 and SPY002

  • Intervention Specific Appendix - SPY130: Part BTreatment being tested

    Participants will receive double-blind dose of SPY001 and SPY003

    Treatment: SPY001 and SPY003

  • Intervention Specific Appendix - SPY230: Part BTreatment being tested

    Participants will receive double-blind dose of SPY002 and SPY003

    Treatment: SPY002 and SPY003

  • Placebo: Part BPlacebo, for comparison

    Participants will receive matching placebo

    Treatment: Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Testing Long-acting Antibodies Alone and Combined for Ulcerative ColitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07012395, who can take part
Record updated
27 October 2026