Study on Multiple Investigational Substances Administered Together and Separately to Patients with Ulcerative Colitis

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Lithuania, Mexico, Moldova, Republic of, Netherlands, Poland, Romania, Serbia, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United States (ICTRP)

Identifiant de l'essai ICTRP
CTIS2025-521242-26-00 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
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 (BASEC)

Titre académique
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 - SPY123-201 (ICTRP)

Titre public
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis (ICTRP)

Maladie en cours d'investigation
Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947Therapeutic area: Diseases [C] - Digestive System Diseases [C06] (ICTRP)

Intervention étudiée
Product Name: SPYPBO-102, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: SPYPBO-101, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: SPY002, Product Code:PRD12626919, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Product Name: SPY002, Product Code:PRD12626916, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: , Product Name: SPY001-001, Product Code:PRD12458650, Pharmaceutical Form: SOLUTION FOR INJECTION, Other descriptive name: , Strength: , Product Name: SPY001-001, Product Code:PRD12458649, Pharmaceutical Form: SOLUTION FOR INFUSION, Other descriptive name: , Strength: (ICTRP)

Type d'essai
Interventional clinical trial of medicinal product (ICTRP)

Plan de l'étude
Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Number of treatment arms in the trial: (ICTRP)

Critères d'inclusion/exclusion
Inclusion criteria: 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-a47, 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). (ICTRP)

Exclusion criteria: 1. Failed (inadequate, lack, or loss of response or intolerance to) 4 or more approved or investigational advanced therapy classes (anti-TNF, anti-a47, 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-a47 (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 Crohns 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.

Critères d'évaluation principaux et secondaires
Main Objective: 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.;Secondary Objective: Part A: 1. To assess the efficacy of intervention in inducing clinical remission following 12 weeks of treatment., Part A: 2. To assess the efficacy of intervention in inducing endoscopic improvement following 12 weeks of treatment., Part A: 3. To assess the efficacy of intervention in improving clinical disease activity following 12 weeks of treatment., Part A: 4. To evaluate pharmacokinetics of intervention during the Induction Treatment Period (ITP)., Part A: 5. To evaluate the presence of anti-drug antibodies (ADA) during the ITP., Part B: 1. To assess the efficacy of intervention in inducing endoscopic improvement following 12 weeks of treatment., Part B: 2. To assess the efficacy of intervention in inducing clinical response following 12 weeks of treatment., Part B: 3. To assess the efficacy of intervention in inducing histologic improvement following 12 weeks of treatment., Part B: 4. To assess the efficacy of intervention in inducing histologic endoscopic mucosal improvement (HEMI) following 12 weeks of treatment., Part B: 5. To assess the efficacy of intervention in achieving clinical remission at the end of the MTP., Part B: 6. To evaluate pharmacokinetics of study drug(s) during the Induction Treatment Period (ITP)., Part B: 7. To evaluate the presence of anti-drug antibodies (ADA) during the ITP.;Primary end point(s): Part A: Change in RHI from baseline at Week 12., Part B: Clinical remission at Week 12. (ICTRP)

Secondary end point(s):Part A: 1. Clinical remission at Week 12.;Secondary end point(s):Part A: 2. Endoscopic improvement at Week 12.;Secondary end point(s):Part A: 3. Change in modified Mayo score from baseline at Week 12.;Secondary end point(s):Part A: 4. Study drug concentration through Week 12.;Secondary end point(s):Part A: 5. Percentage of participants with ADAs to study drug(s) through Week 12.;Secondary end point(s):Part B: 1. Endoscopic improvement at Week 12.;Secondary end point(s):Part B: 2. Clinical response at Week 12.;Secondary end point(s):Part B: 3. Histologic improvement at Week 12.;Secondary end point(s):Part B: 4. HEMI at Week 12.;Secondary end point(s):Part B: 5. Clinical remission at Week 48.;Secondary end point(s):Part B: 6. Study drug concentration through Week 12.;Secondary end point(s):Part B: 7. Percentage of participants with ADA to study drug(s) through Week 12. (ICTRP)

Date d'enregistrement
21.07.2025 (ICTRP)

Inclusion du premier participant
04.12.2025 (ICTRP)

Sponsors secondaires
non disponible

Contacts supplémentaires
SKYLINE-UC Trial Center, info@skyline-uc.com, +16504024238, Spyre Therapeutics Inc. (ICTRP)

ID secondaires
NCT07012395, U1111-1319-5758 (ICTRP)

Résultats-Données individuelles des participants
No (ICTRP)

Informations complémentaires sur l'essai
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2025-521242-26-00 (ICTRP)