NIPH Clinical Trials Search

Phase 2 Platform Trial of Long-acting Antibodies for Moderately to Severely Active Ulcerative Colitis

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Ulcerative Colitis
Date of first enrollment	01/04/2026
Target sample size	30
Countries of recruitment	Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Bosnia and Herzegovina,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,Chile,Japan,China,Japan,Croatia,Japan,Czech Republic,Japan,France,Japan,Georgia,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,India,Japan,Israel,Japan,Italy,Japan,Jordan,Japan,Kazakhstan,Japan,Lithuania,Japan,Mexico,Japan,Moldova,Japan,Poland,Japan,Romania,Japan,Serbia,Japan,Slovakia,Japan,South Korea,Japan
Study type	Interventional
Intervention(s)	Subjects will be randomized in a blinded manner to one of the following groups: monotherapy groups with three investigational products (SPY001, SPY002, or SPY003), combination therapy groups consisting of two of these agents, SPY120 (SPY001 + SPY002), SPY130 (SPY001 + SPY003), or SPY230 (SPY002 + SPY003) or a placebo group. Each of he three monotherapy groups includes both a high-dose group and a low-dose group. After randomization, during the initial 12 week induction treatment period, the assigned investigational product will be administered intravenously at Weeks 0, 4, and 12. Thereafter, the same investigational product will be administered subcutaneously at Weeks 24 and 36 in 36 week maintenance treatment period.

Outcome(s)

Primary Outcome

Clinical remission at Week12

Secondary Outcome

Endoscopic improvement at Week 12 Clinical response at Week 12 Histologic improvement at Week 12 HEMI at Week 12 Clinical remission at Week 48 Study drug concentration through Week 12 Percentage of participants with ADA to study drugs through Week 12 Safety and tolerability of intervention through Week 12 Safety and tolerability of intervention from Week 12 dosing through Week 48 and last follow up visit (if applicable)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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
Exclude 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