A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis

In plain English

What this trial is testing

This study is testing SPY001 (a drug), SPY002 (a drug) and SPY003 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis, Inflammatory Bowel Diseases and Colitis.

Participants are assigned to groups by chance (randomized).

Some participants receive a placebo or sham for comparison.

It is blinded: participants and the study team do not know who receives what.

Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.

Who can join

• Ages 18 to 75
• Any sex

Some of the main requirements, copied from the record:

• 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

There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 645 participants are expected to take part.
• The study has 13 groups.
• Start date: 2025-05-27.
• Main results expected around 2027-06 (estimate from the record).
• 273 study sites listed (273 marked recruiting) in Argentina, Australia, Austria, Belgium and Bosnia and Herzegovina and 30 more countries.

Groups in this study

• Intervention Specific Appendix - SPY001: Part A (listed as: experimental group)
• Intervention Specific Appendix - SPY002: Part A (listed as: experimental group)
• Intervention Specific Appendix - SPY003: Part A (listed as: experimental group)
• Intervention Specific Appendix - SPY001 Dosing Regimen 1: Part B (listed as: experimental group)
• Intervention Specific Appendix - SPY001 Dosing Regimen 2: Part B (listed as: experimental group)
• Intervention Specific Appendix - SPY002 Dosing Regimen 1: Part B (listed as: experimental group)

Main thing being measured

• Part A: Change in Robarts Histopathology Index (RHI) (Week 12)
• Part B: Percentage of participants with clinical remission (Week 12)

In the researchers’ words

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.

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.