Idiopathic Pulmonary Fibrosis
Conditions
Brief summary
This trial was performed in patients with idiopathic pulmonary fibrosis (IPF) to evaluate the clinical efficacy and safety of different doses of TDI01 Suspension, compared with control, for the treatment of patients with IPF.
Detailed description
This is a Phase II, multi-center, randomized, double-blinded, placebo-controlled clinical study to evaluate the efficacy and safety of TDI01 Suspension for the treatment of IPF. The study consists of a 4-week screening period, a 24-week treatment period, a 28-week extension period, and a 2-week safety follow-up period. It is planned to include 120 IPF patients. All subjects will be randomized in a 1:1:1 ratio to receive a 24-week treatment with TDI01 Suspension dosage A, TDI01 Suspension dosage B, or the placebo. At Week 24, the subjects will be evaluated for the primary efficacy endpoints and subsequently enter the extension period. Subjects may continue receiving the investigational product until Week 52 at their voluntary consent.
Interventions
DRUGTDI01 suspension
Experimental group 1: Drug: TDI01 suspension Administration: TDI01 suspension once daily. Experimental group 2: Drug: TDI01 suspension Administration: TDI01 suspension once daily. Control group: Drug: Placebo Administration: Placebo once daily.
Sponsors
Beijing Tide Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Females or males aged 40 to 80 (inclusive) at the time of signing the ICF; 2. Is willing to participate voluntarily in this clinical study and sign the ICF prior to study initiation; 3. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to the principles of the 2022 ATS/ERS/JRS/ALAT clinical practice guidelines; 4. Females or males of reproductive potential must agree and commit to using effective contraception from the time of signing the ICF until 90 days after the last dose of the investigational product; 5. Has stable anti-fibrosis treatment for at least 12 weeks prior to Visit 1. 6. FEV1/FVC ≥0.70 at screening; 7. Percent predicted forced vital capacity (% FVC) ≥45% and ≤90% at screening; 8. DLco% (Hb corrected) ≥30% and ≤90% at screening; 9. Is willing and able to comply with the protocol and attend visits as assessed by the investigator.
Exclusion criteria
Subjects are not eligible for participation in the study if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Forced Vital Capacity (FVC) (mL) at Week 24 | At 24 week | The mean change in FVC (ml) from baseline at week 24, measured by spirometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects with an Absolute Decrease of FVC% Predicted Greater than 10% | From baseline up to week 52 | The proportion of subjects with an absolute decrease of FVC% greater than 10% measured by spirometer from baseline. The time point which will be measured are from baseline to Week 24, and Extension Week 52. |
| Change From Baseline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) % | From baseline up to week 24 | The Change of DLCO% with Hb correction measured by spirometer from baseline. The time point which will be measured are from baseline to Week 12 and Week 24. |
| Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation | From baseline up to week 52 | Time to first acute idiopathic pulmonary fibrosis exacerbation during the trial. |
| Change From Baseline in FVC% Predicted | From baseline up to week 52 | The change in FVC as a percentage of expected value (FVC%) ffrom baseline measured by spirometer. The time points which will be measured are from baseline to Week 12, Week 24, Extension Week 32, Extension Week 40, and Extension Week 52. |
| Mean Change in Distance Walked in the 6-minute Walk Test (6MWT) | From baseline up to week 24 | The mean change in 6MWD. The time points which will be measured are from baseline to Week 12 and Week 24. |
| The change in St.George's respiratory questionnaire（SGRQ） | From baseline up to week 24 | The mean change in total score of SGRQ from basline to Week 12 and Week 24. The SGRQ is a standardized self-completed questionnaire for measuring impaired health and perceived well-being in airways disease. It consists of multiple parts on different scales related to each question to assess the impact of respiration on the subject's life. A total score is ranged from 0 (no health impairment) to 100 (maximum health impairment). The lower the better. |
| Time to Disease Progression | From baseline up to week 52 | Time to Disease Progression during the trial. Disease progression is defined as 10% absolute decrease in FVC, lung transplant or death, whichever occurs first. |
Contacts
Primary ContactDai HuaPing, MD
Outcome results
None listed