Skip to content
DataLookout
Start free
Menu

NCT07933133

A Multicenter, Randomized, Blinded, Placebo- and Active-Controlled Phase II Study to Evaluate the Efficacy and Safety of SYH9061 in Adult Patients With Idiopathic Pulmonary Fibrosis

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 1 version: 1 with changes below.

  1. Study First Submitted

Endpoints

Primary

Change in FVC from baseline (mL)
Timeframe: Week 12

Secondary (29)

Change in FVC from baseline (mL)
Change in FVCpp from baseline
Proportion of participants with an absolute decrease in FVCpp >10% from baseline
Adjusted change in DLCOpp from baseline
Changes in total L-PF score, symptom domain, and impact domain from baseline
Show 24 moreShow less
Changes in IPF symptoms (cough, dyspnea, fatigue) assessed by VAS from baseline
Percent Change from Baseline in the Degree of Quantitative Lung Fibrosis (QLF)
Incidence and severity of adverse events/serious adverse events and adverse reactions/serious adverse reactions during the trial
Proportion of patients with gastrointestinal symptoms (diarrhea, nausea, vomiting, and abdominal pain) during the treatment period
Proportion of participants with dose reduction of the study drug during the extension treatment period
Changes over time in vital signs during the trial
Changes over time in physical examination during the trial
Changes over time in laboratory tests during the trial
Changes over time in 12-lead ECG during the trial
Plasma drug concentrations in participants with sparse sampling
PK parameters after the first dose in participants with intensive sampling: Cmax
PK parameters after the first dose in participants with intensive sampling AUC0-12
PK parameters after the first dose in participants with intensive sampling Tmax
PK parameters at steady state in participants with intensive sampling Ctau,ss
PK parameters at steady state in participants with intensive sampling Cmax,ss
PK parameters at steady state in participants with intensive sampling Cmin,ss
PK parameters at steady state in participants with intensive sampling Cavg,ss
PK parameters at steady state in participants with intensive sampling AUC0-tau,ss
PK parameters at steady state in participants with intensive sampling Tmax,ss
PK parameters at steady state in participants with intensive sampling DF
PK parameters at steady state in participants with intensive sampling swing
PK parameters at steady state in participants with intensive sampling accumulation ratios RAUC
PK parameters at steady state in participants with intensive sampling RCmax (if data permit), etc
Change from baseline in blood biomarkers (e.g., KL-6, etc.)

Arms and interventions

Group A1Experimental

Group SYH9061 4 mg

Group A2Placebo comparator

Group Placebo

Group B1Experimental

Group SYH9061 6 mg

Group B2Placebo comparator

Group Placebo

Group C1Experimental

Group SYH9061 4 mg

Group C2Placebo comparator

Group Placebo

Group D1Active comparator

Group Ofev®

Drugs: SYH9061, Placebo, Ofev®

Sites

1 site in 1 country

  • The First Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, Guangdong, China