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NCT07535489

Efficacy and Safety of IPG11406 in Moderately to Severely Active Ulcerative Colitis (Phase 2)

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Eligibility criteria expanded, about 15 words
    • Start date changed from estimate of Jul 7, 2026 to Aug 27, 2026
    • Site details revised
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Proportion of participants achieving clinical remission at Week 12, as assessed by the modified Mayo Score (mMS)
Timeframe: week 12

Secondary (5)

Proportion of participants achieving clinical response based on mMS at Week 12
Proportion of participants achieving clinical response based on full Mayo Score at Week 12
Proportion of participants achieving clinical remission based on full Mayo Score at Week 12
Proportion of participants achieving combined PRO2 remission and endoscopic remission at Week 12
Proportion of participants achieving endoscopic remission at Week 12

Arms and interventions

IPG11406 10 mg BIDExperimental

Participants in this arm receive IPG11406 10 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design.

IPG11406 20 mg BIDExperimental

Participants in this arm receive IPG11406 20 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design.

IPG11406 40 mg BIDExperimental

Participants in this arm receive IPG11406 40 mg oral tablets twice daily (BID) for 12 weeks, in a double-blind, placebo-controlled design.

PlaceboPlacebo comparator

Participants in this arm receive matching placebo oral tablets twice daily (BID) for 12 weeks, identical in appearance to IPG11406, to maintain the double-blind study design.

Drugs: IPG11406, Placebo

Sites

1 site in 1 country

  • Peking Union Medical College Hospital Chinese Academy of Medical SciencesBeijing, China