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

Part of paid clinical trials in Hamden, Connecticut.

Sponsor
Jiangsu Carephar Pharmaceutical Co., Ltd.
Study ID
NCT07677514
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • H021 Enteric-coated Tablets Low-dose Group — DRUG
    H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 1 tablet
  • H021 Enteric-coated Tablets High-dose Group — DRUG
    H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 2 tablet
  • Placebo Group — DRUG
    Placebo(Specification: 0 mg/tablet)

Study Details

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.

Key Dates

Start date
Jul 12, 2026
Status verified
Jun 2026
Primary completion
Oct 12, 2026
Completion
Nov 12, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: H021 Enteric-coated Tablets Low-dose Group
    H021 Enteric-coated Tablets (Specification: 12.5 mg/tablet) 1 tablet
  • Experimental: H021 Enteric-coated Tablets High-dose Group
    H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 2 tablet
  • Placebo Comparator: Placebo group

Primary Outcome Measure

Proportion of study participants achieving clinical response based on CDAI score at Week 12 [ Time Frame: week 12 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Medical Research Center of ConnecticutHamdenConnecticut06514
Paul Feuerstadt
Alliance Medical Research - Lighthouse PointLighthouse PTFlorida33064
Vipin Gupta
AdventHealth Medical Group Inflammatory Bowel Disease Clinic at OrlandoOrlandoFlorida32804
Jennifer Seminerio-Diehl

Find similar trials in Hamden, CT

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Medical Research Center of Connecticut· Hamden, CTAlliance Medical Research - Lighthouse Point· Lighthouse PT, FLAdventHealth Medical Group Inflammatory Bowel Disease Clinic at Orlando· Orlando, FL

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