A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn's Disease
Public ClinicalTrials.gov record NCT07677514. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07677514
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 156 participants
Conditions and interventions
Conditions
Interventions
- H021 Enteric-coated Tablets Low-dose Group Drug
- H021 Enteric-coated Tablets High-dose Group Drug
- Placebo Group Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 12, 2026 (Estimated)
- Primary completion
- Oct 12, 2026 (Estimated)
- Completion
- Nov 12, 2027 (Estimated)
- Last update posted
- Jun 30, 2026
2026 – 2027
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Research Center of Connecticut | Hamden | Connecticut | 06514 | — |
| Alliance Medical Research - Lighthouse Point | Lighthouse PT | Florida | 33064 | — |
| AdventHealth Medical Group Inflammatory Bowel Disease Clinic at Orlando | Orlando | Florida | 32804 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07677514, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 30, 2026 · Synced Oct 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07677514 live on ClinicalTrials.gov.