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A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
EU CTIS ID: 2025-521242-26-00
What this study is testing
Part A: To assess the effects of intervention on histologic disease activity following 12 weeks of treatment; Part B: To assess the efficacy of intervention in inducing clinical remission following 12 weeks of treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female ≥18 years of age.
- 2. Adult participants must have had a diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening.
- 3. Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy, with the exception of up to approximately 15% of the total population permitted to have only proctitis (<15 cm from the anal verge).
- 4. Moderately to severely active disease as defined by a modified Mayo score of 5 to 9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2.
- 5. History of corticosteroid dependence, OR inadequate response, OR loss of response OR intolerance to 1 of the following: a) conventional therapy only (oral locally acting or systemic corticosteroids, or immunosuppressants) (target of approximately 40%-60% of the planned sample size); OR b) approved advanced therapies, i.e.: anti-TNF, anti-α4β7, anti-IL-12/IL-23, anti-IL-23, JAK inhibitors, or S1P receptor antagonists) (target of approximately 40%-60% of the planned sample size).
- 6. Participants taking oral corticosteroids (up to 20 mg/day prednisone or equivalent, 9 mg/day budesonide, or 5 mg/day beclomethasone) must be on a stable dose for ≥2 weeks prior to Day 1 and be willing to stay on the same dose during the ITP (for Part A participants), or through Week 6 and initiate taper at Week 6 (for Part B participants).
You likely can't join if
- 1. Failed (inadequate, lack, or loss of response or intolerance to) 4 or more approved or investigational advanced therapy classes (anti-TNF, anti-α4β7, anti-IL-12/IL-23, anti-IL-23, JAK inhibitors, and S1P receptor antagonists) at the approved labeled dose or higher, if applicable.
- 2. Failed (inadequate response, loss of response, or intolerance to) 2 or more of the following classes (whether drug is approved or investigational) at an approved labeled dose or higher, if applicable: – anti-α4β7 (e.g., vedolizumab), – anti-TL1A, or – anti-IL-23 (eg, mirikizumab, guselkumab, risankizumab). Note that ustekinumab failure is not applicable to this exclusion criterion.
- 3. Current diagnosis of Crohn’s disease or IBD-Undefined.
- 4. History of colectomy (total, subtotal, partial) or ileostomy.
- 5. If female, pregnant (including those with positive pregnancy test prior to randomization), breastfeeding, or lactating.
- 6. History and/or current symptoms of infections, including TB, Chronic Hepatitis B or C, COVID-19, HIV, Clostridioides difficile toxin, herpes zoster and Cytomegalovirus.
See the full eligibility criteria
Who can join
- 1. Male or female ≥18 years of age.
- 2. Adult participants must have had a diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening.
- 3. Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy, with the exception of up to approximately 15% of the total population permitted to have only proctitis (<15 cm from the anal verge).
- 4. Moderately to severely active disease as defined by a modified Mayo score of 5 to 9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2.
- 5. History of corticosteroid dependence, OR inadequate response, OR loss of response OR intolerance to 1 of the following: a) conventional therapy only (oral locally acting or systemic corticosteroids, or immunosuppressants) (target of approximately 40%-60% of the planned sample size); OR b) approved advanced therapies, i.e.: anti-TNF, anti-α4β7, anti-IL-12/IL-23, anti-IL-23, JAK inhibitors, or S1P receptor antagonists) (target of approximately 40%-60% of the planned sample size).
- 6. Participants taking oral corticosteroids (up to 20 mg/day prednisone or equivalent, 9 mg/day budesonide, or 5 mg/day beclomethasone) must be on a stable dose for ≥2 weeks prior to Day 1 and be willing to stay on the same dose during the ITP (for Part A participants), or through Week 6 and initiate taper at Week 6 (for Part B participants).
What rules you out
- 1. Failed (inadequate, lack, or loss of response or intolerance to) 4 or more approved or investigational advanced therapy classes (anti-TNF, anti-α4β7, anti-IL-12/IL-23, anti-IL-23, JAK inhibitors, and S1P receptor antagonists) at the approved labeled dose or higher, if applicable.
- 2. Failed (inadequate response, loss of response, or intolerance to) 2 or more of the following classes (whether drug is approved or investigational) at an approved labeled dose or higher, if applicable: – anti-α4β7 (e.g., vedolizumab), – anti-TL1A, or – anti-IL-23 (eg, mirikizumab, guselkumab, risankizumab). Note that ustekinumab failure is not applicable to this exclusion criterion.
- 3. Current diagnosis of Crohn’s disease or IBD-Undefined.
- 4. History of colectomy (total, subtotal, partial) or ileostomy.
- 5. If female, pregnant (including those with positive pregnancy test prior to randomization), breastfeeding, or lactating.
- 6. History and/or current symptoms of infections, including TB, Chronic Hepatitis B or C, COVID-19, HIV, Clostridioides difficile toxin, herpes zoster and Cytomegalovirus.
- 7. Intervention Specific Appendix-SPY001, Part A Only: Failure (inadequate response, loss of response, or intolerance) of vedolizumab as defined in Master Protocol Appendix 2.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- Jordan
- Turkey
- Korea, Republic of
- Moldova, Republic of
- Brazil
- Switzerland
- Georgia
- Australia
- Japan
- Argentina
- United States
- Ukraine
- Serbia
- Israel
- Chile
- Taiwan
- Kazakhstan
- Canada
- China
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; Jordan; Turkey; Korea, Republic of; Moldova, Republic of; Brazil and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.