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LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Study Purpose

This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

- Treatment naïve patients or those with <6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines.

- Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers.

- DLCO corrected for Hemoglobin (Hb) [visit 1] ≥ 30% and ≤90% of predicted of normal.

- FVC ≥ 45% of predicted normal.

Key

Exclusion Criteria:

- Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at Visit 1) - Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer.

- Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis.

- Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion) - Cardiovascular diseases, any of the following: - Uncontrolled hypertension, within 3 months of Visit 1.

- Myocardial infarction within 6 months of Visit 1.

- Unstable cardiac angina within 6 months of Visit 1.

- Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05321420
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	PureTech
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Carol Satler, MD
Principal Investigator Affiliation	PureTech
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Chile, Colombia, Georgia, Greece, India, Korea, Republic of, Malaysia, Mexico, Philippines, Romania, South Africa, Thailand, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis
Study Website:	View Trial Website

Additional Details

This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated. After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.

Arms & Interventions

Arms

Placebo Comparator: Placebo

Placebo oral administration

Active Comparator: pirfenidone 801 mg TID

pirfenidone 801 mg TID oral administration

Experimental: LYT-100 550 mg TID

LYT-100 (Deupirfenidone) 550 mg TID oral administration

Experimental: LYT-100 825 mg TID

LYT-100 (Deupirfenidone) 825 mg TID oral administration

Interventions

Drug: - Placebo

placebo

Drug: - Pirfenidone

pirfenidone 801 mg TID

Drug: - Deupirfenidone

Deupirfenidone

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama Birmingham

Birmingham, Alabama, 35294

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