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

Last updated: November 15, 2024
Sponsor: Guangzhou JOYO Pharma Co., Ltd
Overall Status: Active - Recruiting

Phase

2/3

Condition

Idiopathic Pulmonary Fibrosis

Lung Disease

Cystic Fibrosis

Treatment

Placebo comparator

SC1011

Clinical Study ID

NCT06125327
JYP1011M201
  • Ages 40-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to understand and sign written informed consent.

  • The diagnosis time of IPF before enrollment was less than 5 years.

  • Combination of High Resolution Computerized Tomography (HRCT) pattern, and ifavailable surgical lung biopsy pattern, as assessed by central reviewers, areconsistent with diagnosis of IPF.

  • Dlco (corrected for Hb): 30%-90% predicted of normal.

  • FVC>= 50% predicted of normal.

Exclusion

Exclusion Criteria:

  • Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 after administration ofbronchodilator at Screening

  • Expected to receive a lung transplant within 1 year from randomization or, forpatients at sites in the United States, on a lung transplant waiting list atrandomization.

  • Known explanation for interstitial lung disease

  • History of asthma or chronic obstructive pulmonary disease

  • Active infection

  • Ongoing IPF treatments including investigational therapy, immunosuppressants, andcytokine modulating agents

  • History of unstable or deteriorating cardiac or pulmonary disease (other than IPF)within the previous 6 months

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Placebo comparator
Phase: 2/3
Study Start date:
June 06, 2023
Estimated Completion Date:
December 31, 2027

Study Description

Randomized, double-blind study comparing Sufenidone (SC1011) and placebo in IPF patients, with interim analysis at 26 weeks to select the optimal dose for a 52-week treatment period followed by 4-week safety monitoring

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100703
    China

    Active - Recruiting

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