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

A Randomized, Double-blind, Placebo-controlled Phase II/III Trial Evaluating the Efficacy and Safety of Sufenidone (SC1011) Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF).

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

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Placebo comparator; Drug: SC1011

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: zuojun xu; Phone Number: +86 010-69156114; Email: Xuzj@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100703
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Zuojun Xu, Medical Doctor; Phone Number: +86 010-69156114; Email: Xuzj@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Patients receive the dose of placebo orally twice daily (b.i.d) for 52 weeks.; Other Names: comparator
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.	Drug: SC1011; Patients receive the dose of SC1011 tablets orally twice daily (b.i.d) for 52 weeks.; Other Names: Active Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks	SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)	Baseline and 52 weeks
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation.	Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint.	Secondary outcome measures will be assessed at baseline and again at 52 weeks.

Collaborators and Investigators

• Sponsor: Guangzhou JOYO Pharma Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 4, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Lung Diseases; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
• Other Study ID Numbers: JYP1011M201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No