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

NCT07677514 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-06-30

No results posted yet for this study

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

Interventions

DRUG

H021 Enteric-coated Tablets Low-dose Group

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

DRUG

H021 Enteric-coated Tablets High-dose Group

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

DRUG

Placebo Group

Placebo(Specification: 0 mg/tablet)

Sponsors & Collaborators

  • Jiangsu Carephar Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-12
Primary Completion
2026-10-12
Completion
2027-11-12
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07677514 on ClinicalTrials.gov