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

Guangzhou JOYO Pharma

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Placebo comparator; Drug: SC1011

Study type: Interventional

Funder types: Industry

Identifiers

NCT06125327

JYP1011M201

Details and patient eligibility

About

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

Full 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

Enrollment: 210 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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 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.
• FVC>= 50% predicted of normal.

Exclusion criteria

• 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
• Active infection
• Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
• History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 2 patient groups, including a placebo group

Placebo Comparator

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo comparator

SC1011 200mg

Experimental group

Description:

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.

Treatment:

Drug: SC1011