CLINICAL TRIAL / NCT05671835
Study of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
- Interventional
- Recruiting
- NCT05671835
REVERT-IPF: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants With Idiopathic Pulmonary Fibrosis
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).
Gender
All
Age Group
40 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. 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 7 years prior to the date of informed consent.
2. Chest high-resolution computed tomography scan (HRCT) performed within 12 months
prior to providing informed consent meeting requirements for IPF diagnosis based on
2018 or 2022 ATS/ERS/JRS/ALAT guidelines and confirmed by central review.
3. Greater than 40% 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.
4. A predicted diffusing capacity of the lungs for carbon monoxide (DLCO) (hemoglobin
[Hb] corrected) ≥25% during screening confirmed by central review.
5. Oxygen saturation (SpO2) ≥88% with up to 4L O2/min by pulse oximetry at rest.
6. 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.
7. Has a life expectancy of at least 12 months.
Exclusion Criteria:
1. Unresolved respiratory tract infection within 4 weeks (including coronavirus disease
2019 [COVID-19] infections) or an acute exacerbation of IPF within 3 months prior to
screening.
2. Planned surgery during the study.
3. 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.
4. 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.
5. 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.
6. 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.
7. History or difficulty of swallowing, malabsorption, or other chronic
gastrointestinal disease or conditions that may hamper compliance and/or absorption
of the study drug.
8. 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.
9. Received pirfenidone within 3 months prior to randomization.
10. Smoking or vaping of any kind within 3 months of screening.