Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of oral daily administration of TTI-101 over a 12-week treatment duration in participants with idiopathic pulmonary fibrosis (IPF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TTI-101 400 mg/day Participants will receive 400 mg/day of TTI-101 twice daily (BID) for 12 weeks. |
Drug: TTI-101
Orally via a tablet.
|
| Experimental: TTI-101 800 mg/day Participants will receive 800 mg/day of TTI-101 BID for 12 weeks. |
Drug: TTI-101
Orally via a tablet.
|
| Experimental: TTI-101 1200 mg/day Participants will receive 1200 mg/day of TTI-101 BID for 12 weeks. |
Drug: TTI-101
Orally via a tablet.
|
| Placebo Comparator: Placebo Participants will receive a matching placebo BID for 12 weeks. |
Drug: Placebo
Orally via a tablet.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with an Adverse Event (AE) [16 weeks]
Incidence of AEs, including serious AEs assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V.5.0. Clinically significant changes between baseline and postbaseline laboratory assessments, electrocardiograms, vital signs, and physical examinations will be recorded as AEs.
Secondary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of TTI-101 [Day 1 to Week 12]
- Time of Maximum Observed Plasma Concentration (tmax) of TTI-101 [Day 1 to Week 12]
- Area Under the Plasma Concentration-time Curve Over a Dosing Interval (AUC[0-τ]) of TTI-101 [Day 1 to Week 12]
- Trough Plasma Concentration (Cτ) of TTI-101 [Day 1 to Week 12]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with IPF based on either the 2018 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) International Diagnostic Guidelines or on the 2022 updated guidelines within 5 years prior to the date of informed consent.
-
Chest high-resolution computed tomography scan (HRCT) performed within 12 months prior to providing informed consent meeting requirements for IPF diagnosis based on 2018 ATS/ERS/JRS/ALAT guidelines and confirmed by central review.
-
Greater than 45% of predicted forced vital capacity (FVC) and a ratio of forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 measured pre-bronchodilator during screening confirmed by central review.
-
A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin [Hb] corrected) ≥30% during screening confirmed by central review.
-
Oxygen saturation (SpO2) ≥88% with up to 2L O2/min by pulse oximetry.
-
If currently receiving nintedanib, dose must have been stable for ≥3 months prior to randomization. If participant has previously discontinued nintedanib, there is a 6 week washout period required before screening can begin.
-
Has a life expectancy of at least 12 months.
Exclusion Criteria:
-
Unresolved respiratory tract infection within 2 weeks (including coronavirus disease 2019 [COVID-19] infections) or an acute exacerbation of IPF within 3 months prior to screening.
-
Planned surgery during the study.
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The investigator judges that there has been sustained improvement in the severity of IPF during the 12 months prior to screening, based on changes in FVC, DLCO, and/or HRCT scans of the chest.
-
History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall that, in the opinion of the investigator, would impact the primary protocol endpoint or ability to do pulmonary function tests (PFTs), or otherwise preclude participation in the study.
-
Likely to have lung transplantation during the study. Note: Participant may be on a lung transplant list if the investigator anticipates the participant will be able to complete the study prior to transplant.
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Clinically relevant and uncontrolled cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with the participant's ability to complete this study according to the investigator's judgment, or logistical challenges that, in the opinion of the investigator, preclude adequate participation in the study.
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History or difficulty of swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study drug.
-
Receiving steroids (excluding topical steroids) in excess of a mean of 10 mg/day of prednisolone or its equivalent within 2 weeks prior to randomization.
-
Received pirfenidone within 3 months prior to randomization.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tvardi Therapeutics, Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TVD-101-003P