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

NCT06125327 | Recruiting Phase 2

• 1 other identifier: JYP1011M201
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks

  Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate.

  Primary Outcome measures will be assessed at baseline and again at 52 weeks.

Secondary Outcomes (2)

• Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks

  Baseline and 52 weeks

• Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation.

  Secondary outcome measures will be assessed at baseline and again at 52 weeks.

Study Arms (2)

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.

Drug: Placebo comparator

SC1011 200mg

EXPERIMENTAL

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.

Drug: SC1011

Interventions

SC1011 DRUG

Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.

Also known as: Active Drug

SC1011 200mg

Placebo comparator DRUG

Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.

Also known as: comparator

Placebo Comparator

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou JOYO Pharma Co., Ltd: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100703, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Interventions

Bulk Drugs

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

zuojun xu

CONTACT

+86 010-69156114; Xuzj@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: June 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)