A Randomized Double-blind Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis.

Phase 1

• Conditions: Idiopathic Pulmonary Fibrosis; MedDRA version: 21.1Level: PTClassification code: 10021240Term: Idiopathic pulmonary fibrosis Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2024-511330-13-00
• Lead Sponsor: Puretech Lyt 100 Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-28
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Written or electronic informed consent from the participant prior to any study procedures in a manner approved by an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Human Research Ethics Committee (HREC), Male participants must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or, if engaged in heterosexual relations, any female partner must be postmenopausal, surgically sterile (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or using an acceptable, highly effective contraceptive method from Screening until study completion, including the follow-up period and for no less than 90 days after the last dose of study medication along with the use of male condom, Males will not donate sperm for at least 90 days after the last dose of study medication, Female partners of male participants and female participants will report pregnancy occurring within 90 days from cessation of study medication, Part B: Signed informed consent for Part B prior to any study-mandated procedures, Part B: Participant must have completed Part A of the study through Day 183 of treatment, Part B: In the opinion of the investigator, the participant is a good candidate for continued treatment, Male or female, age of =40 years at the time of informed consent, Able to perform and willing to comply with all study procedures and requirements, Treatment-naïve patients or those with <6 months of exposure to nintedanib with physician-diagnosed IPF based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) 2018 guidelines, IPF on high-resolution computed tomography (HRCT), performed within 12 months of Visit 1 as confirmed by central readers, The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan as determined by the investigator and the central reader, Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin (Hb) [Visit 1] =30% and =90% of predicted normal where available at the study site., FVC =45% of predicted normal, Women of childbearing potential (WOCBP) must be non-pregnant and non-lactating, and must be abstinent from heterosexual intercourse throughout the study and for 30 days following last dose of study medication or agree to use 1 of the acceptable, highly effective methods of double contraception which is defined as male use of a condom AND 1 form of the following: a.oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation b.oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation c.intrauterine device (IUD)

Exclusion Criteria

Participants who, in the judgement of the investigator, are unlikely to be able to fulfill study participation requirements, Use of any of the following drugs within 2 weeks prior to Visit 2/baseline or planned during the duration of the study: a.Strong and moderate CYP1A2 inhibitors (ie, ciprofloxacin, fluvoxamine, enoxacin, methoxsalen, mexiletine, vemurafenib) and phenytoin, rifampin, and terifluonmide (inducers of CYP1A2) b.Medications associated with substantial risk for prolongation of the QTc interval (including but not limited to moxifloxacin, quinidine, procainamide, amiodarone, sotalol) c.Immunosuppressant medications such as azathioprine, cyclophosphamide, cyclosporin A, methotrexate, prednisone at a steady dose >10mg/day or equivalent d.Medications used to treat PH such as endothelin receptor antagonists (eg, ambrisentan, bosentan, and macitentan), phosphodiesterase-5 inhibitors (sildenafil and tadalafil used to treat erectile dysfunction are allowed), guanylate cyclase stimulators (eg, riociguat), prostacyclin analogs (eg, epoprostenol, treprostnil, iloprost), or prostacyclin receptor agonists (eg, selexipag) e.Warfarin, as it may worsen IPF f.Vaccination with a live vaccine is not permitted during the period from 4 weeks prior to Screening to 4 weeks after the last dose. The medical monitor should be consulted if there is any question about a particular vaccine., Significant clinical worsening (as per Investigator’s discretion) of IPF between Screening and Baseline Visits, A current immunosuppressive condition (eg, HIV), Active alcohol or drug abuse, Use of smoked (burnt) tobacco products or vaping/e-cigarettes, Other disease (including malignancy) that may interfere with testing procedures or in the judgement of the investigator may interfere with study participation or may put the participant at risk when participating in this study, Participants with a documented hypersensitivity to LYT-100, Participants with a documented lactose or galactose intolerance, Part B: Participants must not meet any exclusion criteria listed for Part A, Part B: Participants who discontinued study medication and started receiving commercially available antifibrotic medication during Part A will not be eligible for Part B, Primary obstructive airway physiology (pre-bronchodilator forced expiratory volume in the first second [FEV1]/FVC <0.7 at Visit 1), Part B: Participants whose treatment assignment is unblinded during Part A will not be eligible for Part B, Part B: AST, ALT, or total bilirubin >3 × ULN, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN) at Visit 1, Part B: Any known factor or disease that interferes with treatment compliance, study conduct, or interpretation of the results, as judged by the investigator, Total bilirubin >1.5 × ULN at Visit 1. Exceptions may be made on a case-by-case basis for participants with Gilbert’s syndrome in consultation with the medical monitor, Creatinine clearance <30 mL/min calculated by Cockcroft–Gault formula at Visit 1 [Note: Laboratory parameters from Visit 1 will be used to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results may be available only after randomization. If the Visit 2 results no longer satisfy the entry criteria, the investigator will determine whether it is justified that the participant remains on study drug. The justification for this decision needs to be documented.], Participants wit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To obtain clinical data establishing the safety, tolerability, efficacy, and dosing regimen of LYT-100 in patients with IPF;Secondary Objective: Part B: Assess the safety and tolerability of long-term treatment with LYT-100 in the IPF population, Part B: Compare the rate of change in FVC through the end of Part B Period 1 to that observed during Part A, by Part A treatment group assignment and by Part B LYT-100 target dose;Primary end point(s): Rate of decline in FVC (in mL) over Part A (26 weeks)