๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-24

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)

๐ŸŸก Not Yet Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Jiangsu Carephar Pharmaceutical Co., Ltd.

๐Ÿฉบ 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

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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,

๐Ÿ“ž 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.

๐Ÿ’ฐ 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.

Explore by condition: All Crohn's Disease clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—