A Clinical Trial on the Treatment of Idiopathic Pulmonary Fibrosis

NCT06102083 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: TDI01-IPF-II-01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Forced Vital Capacity (FVC) (mL) at Week 24

  The mean change in FVC (ml) from baseline at week 24, measured by spirometer

  At 24 week

Secondary Outcomes (7)

• Change From Baseline in FVC% Predicted

  From baseline up to week 52

• Proportion of Subjects with an Absolute Decrease of FVC% Predicted Greater than 10%

  From baseline up to week 52

• Change From Baseline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) %

  From baseline up to week 24

• Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation

  From baseline up to week 52

• Time to Disease Progression

  From baseline up to week 52

Study Arms (3)

Experimental group 1

EXPERIMENTAL

TDI01 dose A, once daily

Drug: TDI01 suspension

Experimental group 2

EXPERIMENTAL

TDI01 dose B, once daily

Drug: TDI01 suspension

Control group

PLACEBO COMPARATOR

Placebo, once daily

Drug: TDI01 suspension

Interventions

TDI01 suspension DRUG

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.

Control group; Experimental group 1; Experimental group 2

Eligibility Criteria

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

You may qualify if:

• Females or males aged 40 to 80 (inclusive) at the time of signing the ICF;
• Is willing to participate voluntarily in this clinical study and sign the ICF prior to study initiation;
• Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to the principles of the 2022 ATS/ERS/JRS/ALAT clinical practice guidelines;
• 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;
• Has stable anti-fibrosis treatment for at least 12 weeks prior to Visit 1.
• FEV1/FVC ≥0.70 at screening;
• Percent predicted forced vital capacity (% FVC) ≥45% and ≤90% at screening;
• DLco% (Hb corrected) ≥30% and ≤90% at screening;
• Is willing and able to comply with the protocol and attend visits as assessed by the investigator.

You may not qualify if:

• Patients with interstitial lung disease caused by other known aetiology;
• 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;
• Patients with IPF significantly worsened within one month prior to randomization;
• Patients with range of emphysema more than that of pulmonary fibrosis as indicated by chest HRCT at screening;
• 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;
• 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;
• 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);
• Patients with moderate to severe hepatic insufficiency (Child-Pugh class B or C) prior to screening;
• 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;
• Patients with uncontrolled hepatitis B virus infection or hepatitis C virus infection at screening;
• Patients with a history of unstable or worsening cardiac disease within 6 months prior to screening;
• Patients with a family or personal history of long QT syndrome or QTcF \>480 ms at screening;
• Patients with a creatinine clearance (CLcr) \<50 mL/min at screening, calculated using the Cockcroft-Gault formula;
• Patients who are unable to complete the 6MWD test or PFT;

Sponsors & Collaborators

• Beijing Tide Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dai HuaPing, MD

CONTACT

010-84206278; daihuaping@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: October 26, 2023
• Study Start: November 2, 2023
• Primary Completion: August 1, 2025
• Study Completion: March 1, 2026
• Last Updated: November 2, 2023

Record last verified: 2023-09