LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) (ELEVATE)
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| ClinicalTrials.gov Identifier: NCT05321420 |
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Recruitment Status :
Active, not recruiting
First Posted : April 11, 2022
Last Update Posted : May 7, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Idiopathic Pulmonary Fibrosis | Drug: Placebo Drug: Pirfenidone Drug: Deupirfenidone | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF) |
| Actual Study Start Date : | July 29, 2022 |
| Estimated Primary Completion Date : | October 2024 |
| Estimated Study Completion Date : | August 2025 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo oral administration
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Drug: Placebo
placebo |
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Active Comparator: pirfenidone 801 mg TID
pirfenidone 801 mg TID oral administration
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Drug: Pirfenidone
pirfenidone 801 mg TID |
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Experimental: LYT-100 550 mg TID
LYT-100 (Deupirfenidone) 550 mg TID oral administration
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Drug: Deupirfenidone
Deupirfenidone |
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Experimental: LYT-100 825 mg TID
LYT-100 (Deupirfenidone) 825 mg TID oral administration
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Drug: Deupirfenidone
Deupirfenidone |
- Rate of decline in Forced Vital Capacity over 26 weeks (Part A) [ Time Frame: 26 weeks ]Rate of decline in Forced Vital Capacity (FVC; in mL)
- Forced Vital Capacity (FVC) percent predicted change (Part A) [ Time Frame: Baseline to Week 26 ]FVC percent predicted (FVCpp) change from baseline to Week 26
- Time to hospitalization or mortality (Part A) [ Time Frame: 26 weeks ]Time to hospitalization or mortality due to respiratory cause through 26 weeks
- Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A) [ Time Frame: 26 weeks ]Time to IPF progression through 26 weeks, as defined by a decline in FVC% of 5% or greater or death
- Forced Vital Capacity (FVC) percent predicted change (Part B) [ Time Frame: 26 Weeks ]FVC percent predicted (FVCpp) change from Week 26 to Week 52
- Rate of decline in Forced Vital Capacity over 26 weeks (Part B) [ Time Frame: 26 Weeks ]Rate of decline in Forced Vital Capacity (FVC; in mL) from Week 26 to Week 52
- Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B) [ Time Frame: 26 Weeks ]Time to IPF progression from Week 26 to Week 52, as defined by a decline in FVC% of 5% or greater or death
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321420
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| Study Director: | Carol Satler, MD | PureTech |
| Responsible Party: | PureTech |
| ClinicalTrials.gov Identifier: | NCT05321420 |
| Other Study ID Numbers: |
LYT-100-2022-204 |
| First Posted: | April 11, 2022 Key Record Dates |
| Last Update Posted: | May 7, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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IPF lung fibrosis respiratory disease |
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Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Pirfenidone Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents |