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

NCT07677514 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: KFP-2025-H021-203
• Study Type: interventional
• Target: 156
• Locations: 2 countries
• Sites: 24

Brief Summary

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.

Conditions

Crohn's Disease

Keywords

H021 Enteric-coated Tablets; Moderately to Severely Active Crohn's Disease (CD); Phase II

Outcome Measures

Primary Outcomes (1)

• Proportion of study participants achieving clinical response based on CDAI score at Week 12

  week 12

Secondary Outcomes (30)

• Proportion of study participants achieving clinical remission based on CDAI score at Week 12

  week 12

• Proportion of study participants achieving endoscopic response at Week 12

  week 12

• Proportion of study participants achieving endoscopic remission at Week 12

  week 12

• Proportion of study participants achieving clinical remission based on CDAI score at Week 52

  Week 52

• Proportion of study participants achieving endoscopic remission at Week 52

  Week 52

Study Arms (3)

H021 Enteric-coated Tablets Low-dose Group

EXPERIMENTAL

H021 Enteric-coated Tablets (Specification: 12.5 mg/tablet) 1 tablet

Drug: H021 Enteric-coated Tablets Low-dose Group

H021 Enteric-coated Tablets High-dose Group

EXPERIMENTAL

H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 2 tablet

Drug: H021 Enteric-coated Tablets High-dose Group

Placebo group

PLACEBO COMPARATOR

Drug: Placebo Group

Interventions

Placebo Group DRUG

Placebo(Specification: 0 mg/tablet)

Placebo group

H021 Enteric-coated Tablets Low-dose Group DRUG

H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 1 tablet

H021 Enteric-coated Tablets Low-dose Group

H021 Enteric-coated Tablets High-dose Group DRUG

H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 2 tablet

H021 Enteric-coated Tablets High-dose Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years to ≤75 years, regardless of gender;
• Diagnosis of Crohn's disease (CD) ≥12 weeks prior to screening, with endoscopic and histopathological evidence required for CD confirmation. If no histological results are available at screening, biopsy results from the screening period may be used;
• Have active moderately to severely active CD, defined as: CDAI score between 220 and 450 (inclusive), and evidence of active mucosal inflammation (involving at least the ileum and/or colon) confirmed by ileocolonoscopy (central reading) performed during the screening period, with a Simplified Endoscopic Score for Crohn's Disease (SES-CD) ≥6 for ileocolonic or colonic disease (SES-CD ≥4 for isolated ileal disease);
• If the patient is using the following medications for CD at screening, they must have been on stable treatment during the screening period and the requirements during the study are as follows:
• Oral 5-aminosalicylic acid (5-ASA) stable treatment for ≥2 weeks prior to screening endoscopy and must remain stable during the study;
• Oral corticosteroids equivalent to prednisone dose ≤20 mg/day or budesonide ≤9 mg/day, stable for ≥2 weeks prior to endoscopy during screening and must remain stable during the double-blind induction treatment period;
• Oral immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate) stable treatment for ≥4 weeks prior to screening endoscopy and must remain stable during the study. Patients taking methotrexate are advised to supplement with folic acid (specific dose determined by the investigator) unless contraindicated;
• Female participants must meet one of the following conditions:
• Postmenopausal status: Postmenopausal is defined as the absence of menstruation for at least 12 consecutive months without other medical explanation. For women not using hormonal contraception or hormone replacement therapy (HRT), menopausal status can be confirmed by detecting follicle-stimulating hormone (FSH) levels within the menopausal range.
• Note: For women receiving HRT whose menopausal status is uncertain, if they wish to continue HRT during the study, a highly effective non-estrogen-containing hormonal contraceptive method must be used (see Section 7.4.1.8).
• Permanent infertility: including but not limited to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
• Women of childbearing potential: May only be enrolled if they and their non-sterilized male sexual partner agree to consistently use highly effective contraception (as defined in Section 7.4.1.8) from the time of signing the informed consent form until at least 30 days after the last dose of study treatment.
• Note: A woman of childbearing potential is defined as a woman who has experienced menarche, is premenopausal, and has not undergone permanent sterilization. The use of contraceptive methods must comply with the relevant regulations regarding contraceptive requirements for clinical studies in the region where the participant is located.
• Female participants must not be pregnant or breastfeeding from the screening period until 30 days after the last dose of study treatment (or longer as required by local regulations), and must have no plans to become pregnant or donate eggs.
• Male participants:

You may not qualify if:

• History of allergy to any component of the investigational product (including the investigational drug and placebo);
• Study participants who have previously received treatment that upregulates microRNA-124 (miR-124) (e.g., ABX464);
• Study participants who have failed more than three advanced therapies for CD, or who have failed two advanced therapies for CD with different mechanisms of action;
• Treatment with cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or thalidomide within 4 weeks prior to screening endoscopy;
• Treatment with biologics (e.g., anti-TNF, anti-integrin, anti-IL-23 or anti-IL-12/23) within 8 weeks prior to screening endoscopy or within 5 half-lives of the drug (whichever is longer);
• Study participants who have previously received natalizumab (or any other α4β1 integrin antagonist) treatment;
• Treatment with small-molecule targeted drugs (e.g., upadacitinib) within 4 weeks prior to screening endoscopy or within 5 half-lives of the drug (whichever is longer);
• Treatment with intravenous medium- to high-dose corticosteroids (e.g., methylprednisolone 60 mg/day or hydrocortisone 300 mg/day) within 2 weeks prior to screening endoscopy;
• Discontinuation of oral immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate) within 4 weeks prior to screening endoscopy, or discontinuation of oral 5-ASA or oral corticosteroids within 2 weeks prior to screening endoscopy;
• Treatment with rectal aminosalicylate preparations or corticosteroids, other enemas/suppositories (except those required for endoscopy) within 2 weeks prior to screening endoscopy;
• Total enteral nutrition or total parenteral nutrition, or fecal microbiota transplantation within 4 weeks prior to screening endoscopy;
• Known symptomatic intestinal strictures and/or inability to pass the endoscope due to stricturing lesions;
• Evidence or clinical suspicion of other forms of inflammatory bowel disease (ulcerative colitis, indeterminate colitis) or concurrent other active gastrointestinal inflammatory diseases (including but not limited to infectious colitis, ischemic colitis, radiation colitis, microscopic colitis, and uncontrolled celiac disease);
• Conditions related to CD surgery at screening:
• Current ostomy or ileal pouch;

Sponsors & Collaborators

• Jiangsu Carephar Pharmaceutical Co., Ltd.: lead

Study Sites (24)

Medical Research Center of Connecticut

Hamden, Connecticut, 06514, United States

Location

Alliance Medical Research - Lighthouse Point

Lighthouse PT, Florida, 33064, United States

Location

AdventHealth Medical Group Inflammatory Bowel Disease Clinic at Orlando

Orlando, Florida, 32804, United States

Location

Peking University First Hospital

Beijing, China

Location

The First Affiliated Hospital of Bengbu Medical University

Bengbu, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Xiangya Hospital of Central South University

Changsha, China

Location

Chongqing General Hospital

Chongqing, China

Location

The First Affiliated Hospital of Fujian Medical University

Fujian, China

Location

The First Hospital of Quanzhou, Fujian Medical University

Fujian, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, China

Location

Anhui Provincial Hospital

Hefei, China

Location

Huizhou Central People's Hospital

Huizhou, China

Location

Huizhou First People's Hospital

Huizhou, China

Location

Jiujiang First People's Hospital

Jiujiang, China

Location

Yuebei People's Hospital

Shaoguan, China

Location

Shengjing Hospital of China Medical University

Shenyang, China

Location

Shenzhen Longhua District People's Hospital

Shenzhen, China

Location

Taihe Hospital

Shiyan, China

Location

The Central Hospital of Wuhan

Wuhan, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Zhuzhou Central Hospital

Zhuzhou, China

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

zhengyu song

CONTACT

+8617714378726; songzhengyu@carephar.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 30, 2026
• Study Start: July 12, 2026
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): November 12, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CN (21)