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
NCT07933133, Phase 2, Not yet recruiting, CSPC-NBP Pharmaceutical Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | 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 | ClinicalTrials.gov |
| NCT number | NCT07933133 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | CSPC-NBP Pharmaceutical Co., Ltd. | ClinicalTrials.gov |
| Conditions | Idiopathic Pulmonary Fibrosis | ClinicalTrials.gov |
| Interventions | SYH9061, Placebo, Ofev® | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in FVC from baseline (mL) | Week 12 | FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease. | ClinicalTrials.gov |
| Secondary | Change in FVC from baseline (mL) | Week 2,4,8,18,24 | FVC is one of the pulmonary function indicators; FVC values in patients with IPF tend to decrease. | ClinicalTrials.gov |
| Secondary | Change in FVCpp from baseline | Week 12,24 | ClinicalTrials.gov | |
| Secondary | Proportion of participants with an absolute decrease in FVCpp >10% from baseline | Week 12,24 | ClinicalTrials.gov | |
| Secondary | Adjusted change in DLCOpp from baseline | Week 12,24 | ClinicalTrials.gov | |
| Secondary | Changes in total L-PF score, symptom domain, and impact domain from baseline | Week 12,24 | ClinicalTrials.gov | |
| Secondary | Changes in IPF symptoms (cough, dyspnea, fatigue) assessed by VAS from baseline | Week 12,24 | ClinicalTrials.gov | |
| Secondary | Percent Change from Baseline in the Degree of Quantitative Lung Fibrosis (QLF) | Week 24 | ClinicalTrials.gov | |
| Secondary | Incidence and severity of adverse events/serious adverse events and adverse reactions/serious adverse reactions during the trial | During the trial | ClinicalTrials.gov | |
| Secondary | Proportion of patients with gastrointestinal symptoms (diarrhea, nausea, vomiting, and abdominal pain) during the treatment period | During the trial | ClinicalTrials.gov | |
| Secondary | Proportion of participants with dose reduction of the study drug during the extension treatment period | During the trial | ClinicalTrials.gov | |
| Secondary | Changes over time in vital signs during the trial | During the trial | ClinicalTrials.gov | |
| Secondary | Changes over time in physical examination during the trial | During the trial | ClinicalTrials.gov | |
| Secondary | Changes over time in laboratory tests during the trial | During the trial | ClinicalTrials.gov | |
| Secondary | Changes over time in 12-lead ECG during the trial | During the trial | ClinicalTrials.gov | |
| Secondary | Plasma drug concentrations in participants with sparse sampling | Day 1,Week 2 | ClinicalTrials.gov | |
| Secondary | PK parameters after the first dose in participants with intensive sampling: Cmax | Day 1,Week 2 | ClinicalTrials.gov | |
| Secondary | PK parameters after the first dose in participants with intensive sampling AUC0-12 | Day 1,Week 2 | ClinicalTrials.gov | |
| Secondary | PK parameters after the first dose in participants with intensive sampling Tmax | Day 1,Week 2 | ClinicalTrials.gov | |
| Secondary | PK parameters at steady state in participants with intensive sampling Ctau,ss | Day 1,Week 2 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)