SC1011 Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

Sponsor
Guangzhou JOYO Pharma Co., Ltd
Study ID
NCT06125327
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • SC1011 — DRUG
    Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.
  • Placebo comparator — DRUG
    Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.

Study Details

Evaluating Sufenidone (SC1011) in IPF patients for efficacy and safety. Includes screening, treatment, and follow-up, with FVC decline and health checks.

Key Dates

First listed
Nov 9, 2023
Start date
Jun 6, 2023
Status verified
Nov 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Placebo Comparator: Placebo Comparator
    Idiopathic pulmonary fibrosis (IPF) patients were administered placebo matching SC1011 taken orally as tablets (matching the respective SC1011 tablets) twice daily, in the morning and in the evening for 52 weeks.
  • Experimental: SC1011 200mg
    Idiopathic pulmonary fibrosis (IPF) patients were administered SC1011 taken orally as tablets twice daily(200mg daily), in the morning and in the evening for 52 weeks.

Primary Outcome Measure

Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks [ Time Frame: Primary Outcome measures will be assessed at baseline and again at 52 weeks. ]

Central Contacts

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