Idiopathic Pulmonary FibrosisPhase 2NCT06102083
A Clinical Trial on the Treatment of Idiopathic Pulmonary Fibrosis
A Phase 2 study testing TDI01 suspension in people with Idiopathic Pulmonary Fibrosis, run by Beijing Tide Pharmaceutical Co., Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- TDI01 suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2023to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Subjects are not eligible for participation in the study if they meet any of the following exclusion criteria:
- 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;
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- 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;
- Pregnant or lactating women; Further exclusion criteria apply.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase II, Multi-center, Randomized, Double-blinded, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of TDI01 Suspension for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- TDI01 suspension
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDI01 suspensionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | TDI01 dose A, once daily Receives: Drug: TDI01 suspension |
| Experimental group 2 | Experimental | TDI01 dose B, once daily Receives: Drug: TDI01 suspension |
| Control group | Placebo comparator | Placebo, once daily Receives: Drug: TDI01 suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 24 week
Secondary outcomes (7)
Change From Baseline in FVC% Predicted
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.
Measured: From baseline up to week 52
Proportion of Subjects with an Absolute Decrease of FVC% Predicted Greater than 10%
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.
Measured: From baseline up to week 52
Change From Baseline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) %
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.
Measured: From baseline up to week 24
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Time to first acute idiopathic pulmonary fibrosis exacerbation during the trial.
Measured: From baseline up to week 52
Time to Disease Progression
Time to Disease Progression during the trial. Disease progression is defined as 10% absolute decrease in FVC, lung transplant or death, whichever occurs first.
Measured: From baseline up to week 52
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT)
The mean change in 6MWD. The time points which will be measured are from baseline to Week 12 and Week 24.
Measured: From baseline up to week 24
The change in St.George's respiratory questionnaire（SGRQ）
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.
Measured: From baseline up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start2 Nov 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102083
- Sponsor's protocol ID
- TDI01-IPF-II-01
- Status last verified
- Sep 2023
- First submitted
- 31 Jul 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-center, Randomized, Double-blinded, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of TDI01 Suspension for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
- ClinicalTrials.gov ID
- NCT06102083
- Acronym / sponsor ID
- TDI01-IPF-II-01
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Drug: TDI01 suspensionTDI01 dose A, once daily |
| Experimental group 2 | Experimental | Drug: TDI01 suspensionTDI01 dose B, once daily |
| Control group | Placebo comparator | Drug: TDI01 suspensionPlacebo, once daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- Subjects are not eligible for participation in the study if they meet any of the following exclusion criteria:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDI01 suspensionExperimental 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. | Drug | Control group, Experimental group 1, Experimental group 2 |
Primary outcome
Change From Baseline in Forced Vital Capacity (FVC) (mL) at Week 24
Time frame: At 24 week
The mean change in FVC (ml) from baseline at week 24, measured by spirometer
7 secondary outcomes
Change From Baseline in FVC% Predicted
Time frame: From baseline up to week 52
Proportion of Subjects with an Absolute Decrease of FVC% Predicted Greater than 10%
Time frame: From baseline up to week 52
Change From Baseline in Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) %
Time frame: From baseline up to week 24
Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Time frame: From baseline up to week 52
Time to Disease Progression
Time frame: From baseline up to week 52
Mean Change in Distance Walked in the 6-minute Walk Test (6MWT)
Time frame: From baseline up to week 24
The change in St.George's respiratory questionnaire（SGRQ）
Time frame: From baseline up to week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TDI01 suspension in people with Idiopathic Pulmonary Fibrosis, run by Beijing Tide Pharmaceutical Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dai HuaPing, MD (010-84206278, daihuaping@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Forced Vital Capacity (FVC) (mL) at Week 24 (time frame: At 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.