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

NCT07229950 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-02-06

No results posted yet for this study

Summary

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.

Conditions

  • Adult Patients With Moderately to Severely Active Ulcerative Colitis

Interventions

DRUG

HRS-7085

HRS-7085 Low dose po

DRUG

HRS-7085

HRS-7085 High dose po

DRUG

Placebo

Placebo po

Sponsors & Collaborators

  • Shandong Suncadia Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07229950 on ClinicalTrials.gov