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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031260002

Enrollment

Registered

2026-04-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Interventions

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 consistin

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Clinical remission at Week12	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Kazakhstan, Lithuania, Mexico, Moldova, Poland, Romania, Serbia, Slovakia, South Korea

Contacts

Public ContactSayaka Kaji

PSI CRO Japan K.K.

psij_clinical-trials@psi-cro.com+81-3-6821-2417

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026