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Study identifier: NCT07677514 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Not Yet Recruiting

A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn's Disease

Condition: Crohn's Disease  ·  Sponsor: Jiangsu Carephar Pharmaceutical Co., Ltd.

PhasePhase 2
Planned participants156
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

This study employs a multicenter, randomized, double-blind, placebo-controlled, parallel-group, continuous treatment design to evaluate the efficacy, safety, PPK characteristics, and PD effects of H021 Enteric-coated Tablets during both the induction and maintenance treatment periods in patients with moderately to severely active CD. This study consists of an up to 4-week screening period, a 12-week double-blind induction treatment period, a 40-week double-blind maintenance treatment period or open-label extension treatment period, and a 4-week safety follow-up period.

This description comes directly from the study's public registry record.

Talk to the study team

zhengyu song  ·  +8617714378726  ·  songzhengyu@carephar.com

Always discuss trial participation with your own doctor first.

Locations (24)

Medical Research Center of ConnecticutHamden, Connecticut, United States
Alliance Medical Research - Lighthouse PointLighthouse PT, Florida, United States
AdventHealth Medical Group Inflammatory Bowel Disease Clinic at OrlandoOrlando, Florida, United States
Peking University First HospitalBeijing, China
The First Affiliated Hospital of Bengbu Medical UniversityBengbu, China
The Second Xiangya Hospital of Central South UniversityChangsha, China
Xiangya Hospital of Central South UniversityChangsha, China
Chongqing General HospitalChongqing, China
The First Affiliated Hospital of Fujian Medical UniversityFujian, China
The First Hospital of Quanzhou, Fujian Medical UniversityFujian, China
The First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, China
Zhujiang Hospital of Southern Medical UniversityGuangzhou, China

+ 12 more locations — full list on the registry record.

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