A Adaptive Design Clinical Trial to Evaluate the Efficacy and Safety of TDI01 Suspension in the Treatment of Idiopathic Pulmonary Fibrosis (IPF)

NCT07464912 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: TDI01-IPF-III-01
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicentre, randomised, double-blind, placebo-controlled, adaptive design clinical trial to evaluate the efficacy and safety of TDI01 suspension in the treatment of idiopathic pulmonary fibrosis (IPF). The study will be conducted in China and divided into two stages, both of which are multicentre, randomised, double-blind, placebo-controlled studies. Stage 1 aims to evaluate the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients, and Stage 2 aims to further confirm the efficacy and safety of TDI01 suspension compared to the placebo group in the treatment of IPF patients.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Absolute change in forced vital capacity (FVC) (mL) from baseline at Week 24 and week 52.

  Week 24, Week 52.

Secondary Outcomes (8)

• Secondary efficacy endpoints:

  Week 6 ,Week 12

• Secondary Outcome Measure

  Week 24, Week 52

• Secondary Outcome Measure

  Week 24, Week 52

• Secondary Outcome Measure

  Week 24, Week 52

• Secondary Outcome Measure

  Week 24, Week 52

Other Outcomes (1)

• Exploratory endpoints:

  Week 52

Study Arms (2)

TDI01 400 mg

EXPERIMENTAL

400 mg, once daily, shake well before administration, orally on an empty stomach

Drug: TDI01

Placebo

PLACEBO COMPARATOR

Once daily, shake well before administration, orally on an empty stomach

Drug: TDI01

Interventions

TDI01 DRUG

TDI01 suspension

Placebo; TDI01 400 mg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with IPF
• Confirmed diagnosis before screening: Diagnosis was made according to the 2022 clinical practice guideline principles of the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) (see Appendix 1), confirmed by the investigators based on chest high-resolution CT (HRCT) performed within 12 months before Visit 1, and surgical lung biopsy or transbronchial lung cryobiopsy (if available);
• Reconfirmation of IPF diagnosis at screening: And before Visit 2, the independent imaging review panel of experts reviewed and confirmed that the HRCT (HRCT within 3 months before randomisation in the same site was accepted) is consistent with a clinical diagnosis of usual interstitial pneumonia (UIP) or probable UIP for IPF. For subjects with an HRCT finding of "indeterminate for UIP", if a local (previous) surgical lung biopsy or transbronchial lung cryobiopsy has been performed, the pathological slides must be submitted for central review and assessment. If the histopathological features show "UIP" or "probable UIP", the clinical diagnosis of IPF can be confirmed;
• Voluntarily participates in this clinical study and signs the informed consent form before the start of the study;
• Age is 40-80 years (inclusive of 40 and 80 years) at the time of signing the informed consent form, regardless of sex;
• Female or male subjects of childbearing potential agree and commit to using highly effective contraceptive measures (see Appendix 8 in 19.8) from the time of signing the informed consent form until 90 days after the last dose of the investigational medicinal product;
• Stable disease for at least 8 weeks prior to Visit 1. Patients must meet one of the following two criteria:
• Did not receive treatment with nintedanib and/or pirfenidone for at least 8 weeks prior to Visit 1 (including patients not treated with nintedanib/pirfenidone and those who had failed treatment with nintedanib/pirfenidone);
• Or have been receiving a stable\* regimen of nintedanib or pirfenidone for at least 12 weeks prior to Visit 1, and plan to continue receiving this background therapy stably after randomisation \[\*stable treatment is defined as the patient being able to generally tolerate continuous treatment with an unchanged dose of pirfenidone (400 mg TID and above) or nintedanib (100 mg BID and above)\];
• At screening and baseline, forced expiratory volume in one second (FEV1)/FVC ratio ≥ 0.70;
• At screening and baseline, FVC% of predicted is greater than 50% (inclusive);
• DLco (Hb-corrected) percent of predicted normal value is greater than 30% (inclusive) at screening and at baseline;
• Active bacterial, viral, parasitic, or fungal infection requiring systemic treatment within 4 weeks prior to screening, but the infection is judged by the investigator to be cured during the screening period;
• In the investigator's assessment, the subject is willing and able to comply with protocol requirements and attend visits.

You may not qualify if:

• Subjects who meet each of the following criteria will be allowed to participate in this study:
• Diagnosed with IPF
• Confirmed diagnosis before screening: Diagnosis was made according to the 2022 clinical practice guideline principles of the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) (see Appendix 1), confirmed by the investigators based on chest high-resolution CT (HRCT) performed within 12 months before Visit 1, and surgical lung biopsy or transbronchial lung cryobiopsy (if available);
• Reconfirmation of IPF diagnosis at screening: And before Visit 2, the independent imaging review panel of experts reviewed and confirmed that the HRCT (HRCT within 3 months before randomisation in the same site was accepted) is consistent with a clinical diagnosis of usual interstitial pneumonia (UIP) or probable UIP for IPF. For subjects with an HRCT finding of "indeterminate for UIP", if a local (previous) surgical lung biopsy or transbronchial lung cryobiopsy has been performed, the pathological slides must be submitted for central review and assessment. If the histopathological features show "UIP" or "probable UIP", the clinical diagnosis of IPF can be confirmed;
• Voluntarily participates in this clinical study and signs the informed consent form before the start of the study;
• Age is 40-80 years (inclusive of 40 and 80 years) at the time of signing the informed consent form, regardless of sex;
• Female or male subjects of childbearing potential agree and commit to using highly effective contraceptive measures (see Appendix 8 in 19.8) from the time of signing the informed consent form until 90 days after the last dose of the investigational medicinal product;
• Stable disease for at least 8 weeks prior to Visit 1. Patients must meet one of the following two criteria:
• Did not receive treatment with nintedanib and/or pirfenidone for at least 8 weeks prior to Visit 1 (including patients not treated with nintedanib/pirfenidone and those who had failed treatment with nintedanib/pirfenidone);
• Or have been receiving a stable\* regimen of nintedanib or pirfenidone for at least 12 weeks prior to Visit 1, and plan to continue receiving this background therapy stably after randomisation \[\*stable treatment is defined as the patient being able to generally tolerate continuous treatment with an unchanged dose of pirfenidone (400 mg TID and above) or nintedanib (100 mg BID and above)\];
• At screening and baseline, forced expiratory volume in one second (FEV1)/FVC ratio ≥ 0.70;
• At screening and baseline, FVC% of predicted is greater than 50% (inclusive);
• DLco (Hb-corrected) percent of predicted normal value is greater than 30% (inclusive) at screening and at baseline;
• Active bacterial, viral, parasitic, or fungal infection requiring systemic treatment within 4 weeks prior to screening, but the infection is judged by the investigator to be cured during the screening period;
• In the investigator's assessment, the subject is willing and able to comply with protocol requirements and attend visits.

Sponsors & Collaborators

• Beijing Tide Pharmaceutical Co., Ltd: lead
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100023, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

HuaPing Dai, Dr.

CONTACT

8610-84206278; daihuaping@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: TDI01 400 mg group and the placebo group at a 1:1 ratio

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: March 11, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)