AzTrials
AzTrials

Crohn's DiseasePhase 2NCT07677514

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

A Phase 2 study testing H021 Enteric-coated Tablets Low-dose Group and H021 Enteric-coated Tablets High-dose Group in people with Crohn's Disease, run by Jiangsu Carephar Pharmaceutical Co., Ltd. at 24 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
H021 Enteric-coated Tablets Low-dose Group and H021 Enteric-coated Tablets High-dose Group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
24 sitesin 2 countries
Study dates
12 Jul 2026to 12 Nov 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
  • Inadequate response, loss of response, or intolerance to one or more of the following treatments (including corticosteroids, immunosuppressants [azathioprine, 6-mercaptopurine, methotrexate], and advanced therapies such as anti-TNF, anti-integrin, anti-IL-23 or anti-IL-12/23, JAK inhibitors) (failure to 5-aminosalicylic acid [5-ASA] alone does not meet the study inclusion requirements) (it will be determined by the investigator based on the assessment criteria; see Appendix 13.1 for details);
  • 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;
Show all 21Show fewer
  • 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).
  • Or
  • Permanent infertility: including but not limited to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
  • Or
  • 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:
  • Male participants who have not undergone vasectomy and whose sexual partner is a woman of childbearing potential must agree to use acceptable contraception (see Section 7.4.1.8) from the first dose until at least 90 days after the last dose.
  • Male participants must have no plans to father a child or donate sperm during the study and for 90 days after the last dose of study treatment.
  • Voluntarily sign the ICF, willing and able to comply with all planned visits, treatment plan, study assessments (including endoscopy and daily diary entry), laboratory tests, lifestyle considerations, and other study procedures.

Who cannot join

  • 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;
Show all 49Show fewer
  • 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);
  • Presence of untreated active external fistula or perianal fistula or abscess at screening. Patients with stable fistulas without abscess and with minimal or no drainage may be enrolled. For recent skin abscesses and perianal abscesses, if drainage and treatment have been completed at least 3 weeks prior to screening colonoscopy (at least 8 weeks for intra-abdominal abscesses) and no further surgery is anticipated, inclusion is allowed;
  • Conditions related to CD surgery at screening:
  • Current ostomy or ileal pouch;
  • Absence of more than 2 of the following 5 complete intestinal segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid colon and rectum;
  • Previous small bowel resection with total length >100 cm or short bowel syndrome;
  • Intestinal resection surgery within 3 months prior to baseline;
  • Any other manifestation that may require surgery during the study period;
  • Study participants with evidence of colonic dysplasia (excluding completely resected low-grade dysplasia lesions), adenoma (excluding completely resected colonic adenomatous polyps), or neoplasia;
  • History of lymphoproliferative disorders, including lymphoma, or symptoms or signs suggestive of possible lymphoproliferative disorders, such as lymphadenopathy and/or splenomegaly;
  • History of malignancy in the past 5 years (participants with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix may enter this study if they have been cured for at least 12 months prior to signing the ICF);
  • Presence of unstable or poorly controlled diseases, including but not limited to cardiovascular, cerebrovascular, respiratory, gastrointestinal (except CD), hepatic, renal, endocrine, hematologic, or neurological diseases, which may affect patient safety in the study or confound efficacy assessments;
  • History of acute myocardial infarction or unstable angina, severe arrhythmia (multifocal frequent ventricular premature beats, ventricular tachycardia, ventricular fibrillation) within the past 6 months; New York Heart Association (NYHA) functional class III-IV. Study participants with a family or personal history of congenital or acquired long QT syndrome, or with significantly prolonged QTc interval at baseline (QTcF >450 msec for male study participants, QTcF >470 msec for female study participants);
  • Abnormal serological virology tests, including any of the following:
  • Positive for hepatitis B surface antigen (HBsAg);
  • Positive for hepatitis B core antibody (HBc Ab) with detectable HBV-DNA;
  • Positive for hepatitis C antibody (HCV-Ab) (study participants who have been successfully treated and are ≥1 year post-treatment without recurrence and with undetectable HCV RNA are eligible for this study);
  • Positive for human immunodeficiency virus antibody (HIV-Ab) or Treponema pallidum antibody (TP-Ab);
  • Active tuberculosis or latent tuberculosis without prophylactic treatment (for those with latent tuberculosis infection, those receiving prophylactic treatment may be enrolled); or study participants with a history of tuberculosis not fully cured;
  • Positive Clostridioides difficile test at the screening visit; if Clostridioides difficile is positive, the study participant may be treated and retested ≥2 weeks after completing treatment;
  • Study participants with chronic or recurrent Grade 3 or 4 infection within 2 months prior to screening or with a history of opportunistic infection during periods without immunosuppressive therapy; herpes zoster reactivation within 2 months prior to screening; active infection at screening, or any severe infection episode requiring hospitalization or intravenous antibiotics within 1 month prior to screening or during screening (fungal infection of the nail bed is acceptable);
  • Any other history of infection that, in the investigator's opinion, may worsen if the study participant participates in the study;
  • Abnormal laboratory tests during screening, including any of the following:
  • Neutrophil count <0.75x109/L;
  • Hemoglobin ≤80 g/L;
  • Platelet count <100x109/L;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the upper limit of normal (ULN);
  • Total bilirubin >1.5 times ULN (if the direct bilirubin fraction is <35%, isolated bilirubin >1.5×ULN is acceptable); Participants with isolated indirect hyperbilirubinemia consistent with Gilbert's syndrome may be enrolled if other hepatic function parameters are within acceptable limits;
  • Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula without race adjustment (the calculation method is presented in 13.2);
  • History of organ transplantation requiring ongoing immunosuppressive therapy;
  • Receipt of any live vaccine within 3 months prior to randomization; or planned receipt of any live vaccine during the study;
  • Contraindications to colonoscopy;
  • History of drug abuse or alcohol abuse/dependence;
  • Suspected or confirmed pregnancy, or lactating female;
  • Participation in another drug/device clinical study and use of the investigational drug/device within 3 months prior to randomization;
  • Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in this study;
  • Treatment with a narrow therapeutic index CYP1A2 substrate drug (e.g., clozapine, theophylline, ropinirole, warfarin, methadone) within 5 half-lives prior to the start of study treatment

Trial locations and contacts

24 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

zhengyu song contact

+8617714378726

songzhengyu@carephar.com

24 sites in 2 countries

China21 sites

  • Peking University First Hospital

    Beijing

    huahong Wang

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

  • The Second Xiangya Hospital of Central South University

    Changsha

  • Xiangya Hospital of Central South University

    Changsha

  • Chongqing General Hospital

    Chongqing

  • The First Affiliated Hospital of Fujian Medical University

    Fujian

  • The First Hospital of Quanzhou, Fujian Medical University

    Fujian

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou

    Baili Chen

  • Zhujiang Hospital of Southern Medical University

    Guangzhou

  • Anhui Provincial Hospital

    Hefei

  • Huizhou Central People's Hospital

    Huizhou

  • Huizhou First People's Hospital

    Huizhou

  • Jiujiang First People's Hospital

    Jiujiang

  • Yuebei People's Hospital

    Shaoguan

  • Shengjing Hospital of China Medical University

    Shenyang

    feng Tian

  • Shenzhen Longhua District People's Hospital

    Shenzhen

  • Taihe Hospital

    Shiyan

  • The Central Hospital of Wuhan

    Wuhan

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

    Wuhan

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Zhuzhou Central Hospital

    Zhuzhou

Other trials in China

United States3 sites

  • Medical Research Center of Connecticut

    Hamden, Connecticut, 06514

    Paul Feuerstadt

  • Alliance Medical Research - Lighthouse Point

    Lighthouse PT, Florida, 33064

    Vipin Gupta

  • AdventHealth Medical Group Inflammatory Bowel Disease Clinic at Orlando

    Orlando, Florida, 32804

    Jennifer Seminerio-Diehl

Other trials in United States

About this study

Official title: 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)

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
Being tested
H021 Enteric-coated Tablets Low-dose Group, H021 Enteric-coated Tablets High-dose Group, Placebo Group
Keywords
H021 Enteric-coated Tablets, Moderately to Severely Active Crohn's Disease (CD), Phase II
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H021 Enteric-coated Tablets Low-dose GroupDrug

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

  • H021 Enteric-coated Tablets High-dose GroupDrug

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

  • Placebo GroupDrug

    Placebo(Specification: 0 mg/tablet)

Study groups in NCT07677514
Study groupRoleWhat they receive
H021 Enteric-coated Tablets Low-dose GroupExperimentalH021 Enteric-coated Tablets (Specification: 12.5 mg/tablet) 1 tablet
Receives: Drug: H021 Enteric-coated Tablets Low-dose Group
H021 Enteric-coated Tablets High-dose GroupExperimentalH021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 2 tablet
Receives: Drug: H021 Enteric-coated Tablets High-dose Group
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo Group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: week 12

Secondary outcomes (30)

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

    Measured: week 12

  2. Proportion of study participants achieving endoscopic response at Week 12

    Measured: week 12

  3. Proportion of study participants achieving endoscopic remission at Week 12

    Measured: week 12

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

    Measured: Week 52

  5. Proportion of study participants achieving endoscopic remission at Week 52

    Measured: Week 52

  6. Proportion of study participants achieving clinical response based on CDAI score at Weeks 4, 8, 16, 24, 36, and 52

    Measured: Weeks 4, 8, 16, 24, 36, and 52

  7. Proportion of study participants achieving clinical remission based on CDAI score at Weeks 4, 8, 16, 24, and 36

    Measured: Weeks 4, 8, 16, 24, and 36

  8. Proportion of study participants achieving endoscopic response at Week 24 (limited to those who underwent endoscopy at this visit)

    Measured: Week 24

  9. Proportion of study participants achieving endoscopic remission at Week 24 (limited to those who underwent endoscopy at this visit)

    Measured: Week 24

  10. Proportion of study participants achieving endoscopic response at Week 52

    Measured: Week 52

  11. Proportion of study participants achieving both clinical remission and endoscopic response at Week 12

    Measured: Week 12

  12. Proportion of study participants achieving both clinical remission and endoscopic remission at Week 52

    Measured: Week 52

  13. For study participants using corticosteroids at baseline, proportion achieving clinical remission and corticosteroid-free for ≥12 weeks (i.e., from Week 40 to Week 52) at Week 52

    Measured: Week 52

  14. Proportion of study participants achieving clinical remission at both Week 12 and Week 52

    Measured: Week 12 and Week 52

  15. Proportion of study participants achieving endoscopic remission at both Week 12 and Week 52

    Measured: Week 12 and Week 52

  16. Change from baseline in CDAI at Weeks 4, 8, 12, 16, 24, 36, and 52

    Measured: Weeks 4, 8, 12, 16, 24, 36, and 52

  17. Change from baseline in Simplified Endoscopic Score for Crohn's Disease (SES-CD) score at Weeks 12 and 52

    Measured: Weeks 12 and 52

  18. For study participants with draining fistulas at baseline, proportion with ≥50% reduction in the number of draining fistulas at Weeks 12, 24, and 52

    Measured: Weeks 12, 24, and 52

  19. Proportion of study participants with fistula closure among those with fistulas at baseline at Weeks 12, 24, and 52

    Measured: Weeks 12, 24, and 52

  20. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: through study completion, approximately 60 weeks

  21. Change from baseline in miR-124, IL-17A, and IL-23 in tissue biopsies at Weeks 12, 24, and 52 (Week 24 limited to those who underwent endoscopy at this visit)

    Measured: Weeks 12, 24, and 52

  22. Change from baseline in fecal calprotectin at Weeks 4, 8, 12, 24, and 52

    Measured: Weeks 4, 8, 12, 24, and 52

  23. Proportion of study participants with abnormal fecal calprotectin at baseline who return to normal at Weeks 4, 8, 12, 24, and 52

    Measured: Weeks 4, 8, 12, 24, and 52

  24. Change from baseline in serum C-reactive protein (CRP) at Weeks 4, 8, 12, 24, and 52

    Measured: Weeks 4, 8, 12, 24, and 52

  25. Proportion of study participants with abnormal CRP at baseline who return to normal at Weeks 4, 8, 12, 24, and 52

    Measured: Weeks 4, 8, 12, 24, and 52

  26. Change from baseline in blood miR-124 and IL-17A at Weeks 4, 8, 12, 24, and 52

    Measured: Weeks 4, 8, 12, 24, and 52

  27. Evaluate the area under the serum drug concentration-time curve from time zero to the last quantifiable time point (AUC0-t)

    Measured: week 4, week 8 ,week 12

  28. Evaluate the area under the serum drug concentration-time curve from time zero to infinity (AUC0-∞)

    Measured: week 4, week 8 ,week 12

  29. Evaluate the maximum concentration

    Measured: week 4, week 8 ,week 12

  30. 12-lead Electrocardiogram (ECG)

    include:Heart rate (bpm), PR interval (msec), QT interval (msec), QTcF (msec)

    Measured: through study completion, approximately 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study start12 Jul 2026 (estimated)
  3. Primary completion12 Oct 2026 (estimated)
  4. Study completion12 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07677514
Sponsor's protocol ID
KFP-2025-H021-203
Status last verified
Jun 2026
First submitted
11 Jun 2026
Last updated
30 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing H021 Enteric-coated Tablets Low-dose Group and H021 Enteric-coated Tablets High-dose Group in people with Crohn's Disease, run by Jiangsu Carephar Pharmaceutical Co., Ltd. at 24 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact zhengyu song (+8617714378726, songzhengyu@carephar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of study participants achieving clinical response based on CDAI score at Week 12 (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07677514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in