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A Clinical Trial on the Treatment of Idiopathic Pulmonary Fibrosis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
40 Years - 80 Years
Gender
All
More Inclusion & Exclusion Criteria
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
exclusion criteria:
1. Patients with interstitial lung disease caused by other known aetiology;
2. Patients who experienced active tuberculosis infection within 12 months prior to
screening, or present any bacterial, viral, parasitic, or fungal infection requiring
treatment at screening;
3. Patients with IPF significantly worsened within one month prior to randomization;
4. Patients with range of emphysema more than that of pulmonary fibrosis as indicated by
chest HRCT at screening;
5. Patients who are expected to undergo a lung transplant during the course of the study
or have an expected survival of less than 1 year;
6. Patients who received any of the following medications within 28 days prior to
randomization, such as unstable anti-fibrosis treatment, >15 mg/d prednisone or
equivalent dose of other glucocorticoids, immunomodulatory agents,strong inhibitors of
CYP3A4;
7. Patients with a history of malignancy within 5 years prior to screening (except for
patients with appropriately treated basal cell carcinoma of the skin or squamous cell
carcinoma in situ of the skin or carcinoma in situ of the cervix);
8. Patients with moderate to severe hepatic insufficiency (Child-Pugh class B or C) prior
to screening;
9. Patients with laboratory test results exceeding any of the following criteria at
screening: total bilirubin >1.5 x ULN or AST/ALT >2 x ULN, and serum CK >2.5 x ULN;
10. Patients with uncontrolled hepatitis B virus infection or hepatitis C virus infection
at screening;
11. Patients with a history of unstable or worsening cardiac disease within 6 months prior
to screening;
12. Patients with a family or personal history of long QT syndrome or QTcF >480 ms at
screening;
13. Patients with a creatinine clearance (CLcr) <50 mL/min at screening, calculated using
the Cockcroft-Gault formula;
14. Patients who are unable to complete the 6MWD test or PFT;
15. Pregnant or lactating women; Further exclusion criteria apply.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Beijing Tide Pharmaceutical Co., Ltd
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Not yet recruiting
Countries
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Idiopathic Pulmonary Fibrosis
Additional Details
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.
Arms & Interventions
Arms
Experimental: Experimental group 1
TDI01 dose A, once daily
Experimental: Experimental group 2
TDI01 dose B, once daily
Placebo Comparator: Control group
Placebo, once daily
Interventions
Drug: - TDI01 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.
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
