A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment reduced: 66 → 48 participantsv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 6 more changesShow less
    • Enrollment target: 30 to 66
    • Primary and study completion dates: Mar 2026 to Dec 2026
    • Start date changed from estimate of Dec 2025 to Oct 17, 2025
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 5 of 7 entries
    • Site details revised
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.
Trial Details
NCT Number NCT07229950
Lead Sponsor Shandong Suncadia Medicine Co., Ltd.
Conditions
(from sponsor)		 Adult Patients With Moderately to Severely Active Ulcerative Colitis
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov