A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn's Disease (NCT07677514)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of H021 Enteric-coated Tablets in Patients With Moderately to Severely Active Crohn's Disease (CD)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Medical Research Center of Connecticut โ Hamden, Connecticut
Age range: 18 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (24 Sites)
- Medical Research Center of Connecticut โ Hamden, Connecticut
- Alliance Medical Research - Lighthouse Point โ Lighthouse PT, Florida
- AdventHealth Medical Group Inflammatory Bowel Disease Clinic at Orlando โ Orlando, Florida
- Peking University First Hospital โ Beijing,
- The First Affiliated Hospital of Bengbu Medical University โ Bengbu,
- The Second Xiangya Hospital of Central South University โ Changsha,
- Xiangya Hospital of Central South University โ Changsha,
- Chongqing General Hospital โ Chongqing,
- The First Affiliated Hospital of Fujian Medical University โ Fujian,
- The First Hospital of Quanzhou, Fujian Medical University โ Fujian,
- The First Affiliated Hospital of Sun Yat-sen University โ Guangzhou,
- Zhujiang Hospital of Southern Medical University โ Guangzhou,
- Anhui Provincial Hospital โ Hefei,
- Huizhou Central People's Hospital โ Huizhou,
- Huizhou First People's Hospital โ Huizhou,
- Jiujiang First People's Hospital โ Jiujiang,
- Yuebei People's Hospital โ Shaoguan,
- Shengjing Hospital of China Medical University โ Shenyang,
- Shenzhen Longhua District People's Hospital โ Shenzhen,
- Taihe Hospital โ Shiyan,
- The Central Hospital of Wuhan โ Wuhan,
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology โ Wuhan,
- The Second Affiliated Hospital of Zhengzhou University โ Zhengzhou,
- Zhuzhou Central Hospital โ Zhuzhou,
๐ Contact the Study Coordinator
Phone: +8617714378726
Email: songzhengyu@carephar.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn's Disease
- A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD) โ Birmingham, Alabama
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease โ Birmingham, Alabama
- A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. โ Sun City, Arizona
- Study to Assess Speed of Onset and Durability of Effectiveness of Upadacitinib in Adult Participants With Moderate to Severe Crohn's Disease (CD) in Real World Clinical Practice. โ Blacktown, New South Wales
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients โ San Francisco, California
- Dietary Therapy and Gut Microbiome in Crohn's Disease and Ulcerative Colitis โ Boston, Massachusetts
Explore by condition: All Crohn's Disease clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.