A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
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, Placebo.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative. Basic parameters: 18 years — 75 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, Argentina, Australia, Austria, Belgium +30
- 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
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
Overview
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.
Detailed description
This platform study will evaluate the efficacy and safety of investigational treatments, including 3 monotherapies and 3 combination therapies, for moderately to severely active UC in adults. The study will progress in two parts.
Part A is the open-label portion of the study assessing safety and preliminary efficacy of monotherapies. Part A enrollment completed April 2026.
Part B, which will be open for enrollment after Part A, is the randomized, placebo-controlled portion of the study assessing the safety and efficacy of the 6 interventions (3 monotherapies and 3 combinations) compared to placebo. Part B enrollment commenced April 2026.
Intervention arms will be added to the study over time and may complete at different times.
Interventions
- Drug SPY001
Experimental - Drug SPY002
Experimental - Drug SPY003
Experimental - Other Placebo
Placebo
Primary outcome measures
- Part A: Change in Robarts Histopathology Index (RHI) [Time frame: Week 12]
- Part B: Percentage of participants with clinical remission [Time frame: Week 12]
Secondary outcome measures (7)
- Part A: Percentage of participants with clinical remission [Time frame: Week 12]
- Part A: Percentage of participants with endoscopic improvement [Time frame: Week 12]
- Part B: Percentage of participants with endoscopic improvement [Time frame: Week 12]
- Part B: Percentage of participants with clinical response [Time frame: Week 12]
- Part B: Percentage of participants with histologic improvement [Time frame: Week 12]
- Part B: Percentage of participants achieving histologic endoscopic mucosal improvement (HEMI). [Time frame: Week 12]
- Part B: Percentage of participants with clinical remission [Time frame: Week 48]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
- Failed 4 or more approved or investigational advanced therapy classes
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 26 centers
- Site 024 — Canoga Park
- Site 023 — La Jolla
- Site 012 — Lancaster
- Site 033 — Colorado Springs
- Site 007 — Kissimmee
- 029 — Miami
- Site 038 — Chicago
- Site 006 — Kansas City
- … and 18 more centers
Poland · 23 centers
Center list to be confirmed — check the primary protocol.
Japan · 20 centers
Center list to be confirmed — check the primary protocol.
Brazil · 14 centers
- Site 123 — Brasília
- Site 133 — Goiânia
- Site 136 — Juiz de Fora
- Site 137 — Teresina
- Site 125 — Caxias do Sul
- Site 134 — Passo Fundo
- Site 126 — Passo Fundo
- Site 122 — Porto Alegre
- … and 6 more centers
Ukraine · 14 centers
Center list to be confirmed — check the primary protocol.
Italy · 12 centers
Center list to be confirmed — check the primary protocol.
South Korea · 12 centers
Center list to be confirmed — check the primary protocol.
Georgia · 10 centers
Center list to be confirmed — check the primary protocol.
Germany · 9 centers
Center list to be confirmed — check the primary protocol.
Serbia · 7 centers
Center list to be confirmed — check the primary protocol.
Spain · 7 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 7 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 7 centers
Center list to be confirmed — check the primary protocol.
Australia · 6 centers
- Site 208 — Concord
- Site 202 — Heidelberg
- Site 204 — Liverpool
- Site 203 — Melbourne
- Site 206 — South Brisbane
- Site 207 — Woolloongabba
Israel · 6 centers
Center list to be confirmed — check the primary protocol.
Jordan · 6 centers
Center list to be confirmed — check the primary protocol.
Romania · 6 centers
Center list to be confirmed — check the primary protocol.
Belgium · 5 centers
- Site 476 — Ghent
- Site 474 — Sint-Niklaas
- Site 475 — Bruges
- Site 471 — Ghent
- Site 472 — Roeselare
Bulgaria · 5 centers
- Site 494 — Gorna Oryahovitsa
- Site 498 — Rousse
- Site 492 — Sofia
- Site 499 — Sofia
- Site 495 — Sofia
Czechia · 5 centers
- Site 531 — Brno
- Site 536 — Klatovy
- Site 534 — Ostrava
- Site 537 — Pardubice
- Site 538 — Prague
France · 5 centers
- Site 555 — Marseille
- Site 551 — Nantes
- Site 557 — Nice
- … and 2 more centers
Hungary · 5 centers
Center list to be confirmed — check the primary protocol.
India · 5 centers
Center list to be confirmed — check the primary protocol.
Moldova · 5 centers
Center list to be confirmed — check the primary protocol.
Argentina · 4 centers
- Site 105 — La Plata
- Site 102 — Lujan de Cuyo
- Site 103 — Rosario
- Site 104 — San Miguel de Tucumán
Canada · 4 centers
- Site 083 — London
- Site 084 — Toronto
- Site 085 — Greater Sudbury
- Site 086 — London
Greece · 4 centers
Center list to be confirmed — check the primary protocol.
Slovakia · 4 centers
Center list to be confirmed — check the primary protocol.
Bosnia and Herzegovina · 3 centers
- Site 481 — Banja Luka
- Site 484 — Mostar
- Site 483 — Sarajevo
Mexico · 3 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 3 centers
Center list to be confirmed — check the primary protocol.
Chile · 2 centers
- Site 153 — Osorno
- Site 152 — Santiago
Croatia · 2 centers
- Site 521 — Osijek
- Site 524 — Zagreb
Lithuania · 2 centers
Center list to be confirmed — check the primary protocol.
Austria · 1 center
- Site 463 — Linz
Identifiers
NCT: NCT07012395 · SPY123-201