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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorGuangzhou JOYO Pharma Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

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 if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF.

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

Disqualifiers

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

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

Known explanation for interstitial lung disease

History of asthma or chronic obstructive pulmonary disease

Trial design

Treatments tested in this trial

  • SC1011
  • Placebo comparator

Treatment groups

210 Participants
are divided into 2 treatment groups

Sponsors and collaborators