Trial intelligence / Profile preview

H021 Enteric-coated Tablets in Patients With Moderately to Severely Active Crohn's Disease

NCT07677514Phase 2

Key facts

Status: Not yet recruiting
Start: Jul 2026
Primary completion: Oct 2026
Countries: 2
Sponsor: Carephar

Drugs: H021
Conditions: Crohn's disease

Overview

Phase 2, randomised, double-blind trial of H021 in Crohn's disease (3 arms), sponsored by Carephar. Primary endpoint: Clinical Response based on CDAI score at 12 weeks. Planned start Jul 2026; status: not yet recruiting.

Design

3 arms

Study design: RandomizedDouble-blind

H021 Low-dose Group
H021 Enteric-coated Tablets 12.5 mg (1 tablet)
H021 High-dose Group
H021 Enteric-coated Tablets 25 mg (2 tablets)
Placebo Group
Placebo

Who it enrols

Adults with moderately to severely active Crohn's disease who have had an inadequate response, loss of response, or intolerance to conventional or advanced therapies.

Endpoints

Primary

Clinical Response based on CDAI score12 weeks

Secondary

Clinical Remission based on CDAI score52 weeks
Endoscopic Response52 weeks
Endoscopic Remission52 weeks
Clinical Remission and Endoscopic Response12 weeks
Clinical Remission and Endoscopic Remission52 weeks
Corticosteroid-free Clinical Remission52 weeks
Change from baseline in CDAI52 weeks
Change from baseline in Simplified Endoscopic Score for Crohn's Disease52 weeks

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