A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn's Disease (NCT07677514) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn's Disease
United States, China156 participantsStarted 2026-07-12
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of study participants achieving clinical response based on CDAI score at Week 12
. 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:
. 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.
. Permanent infertility: including but not limited to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
Exclusion criteria
. 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;