A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients with Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic pulmonary fibrosis (IPF)MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2020-000791-38-PT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 664
• Age 40–85 years
• Documented diagnosis of IPF per the 2018 American Thoracic Society / European Respiratory Society / Japanese Respiratory Society / Latin American Thoracic Society Clinical Practice Guideline
• High-resolution computed tomography pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)
• Minimum 6MWD of 150 meters with maximum use of 6 L/min at sea-level and up to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of >= 83% during the 6MWT during screening
• FVC >= 45% predicted during screening
• Forced expiratory volume in 1 second (FEV1)/FVC ratio > 0.70 during screening
• DLCO >= 30% and <= 90% of predicted during screening
• If receiving pirfenidone or nintedanib treatment for IPF, the patient must have been on treatment for at least 3 months and on a stable dose for at least 4 weeks prior to screening and during screening
• If not currently receiving nintedanib or pirfenidone treatment must have discontinued such treatment >= 4 weeks prior to screening and during screening
• For women of childbearing potential: agreement to remain abstinent or use contraception, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 8 weeks after the final dose of PRM-151
• For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 8 weeks after the final dose of PRM-151 to avoid exposing the embryo. Men must refrain from donating sperm during this same period
• Anticipated life expectancy of at least 12 months at baseline, according to the investigator’s judgment
• Patient and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study. If the patient is on a lung transplant list, the investigator anticipates the patient will be able to complete the study prior to transplant
• For patients enrolled in the extended China enrollment phase at NMPA-recognized sites: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 178
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480
• Evidence of other known causes of interstitial lung disease
• FVC% predicted value showing improvement in the 6-month period prior to screening and including screening value, as assessed by the investigator Emphysema present on >= 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
• Receiving nintedanib in combination with pirfenidone
• Received cytotoxic, immunosupressive, cytokine modulating, or receptor antagonist agents within 4 weeks of screening
• Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to screening
• Receiving strong inhibitor or inducer of CYP1A2 in patients taking pirfenidone
• Receiving potent inhibitor or inducer of P-gp in patients taking nintedanib
• Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
• Patients with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test [interferon gamma release assay])
• Patients who have completed treatment for active or latent tuberculosis within 6 months prior to screening, and have no evidence of recurrent disease, do not need to be tested
• Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude during screening
• Co-existing acute or chronic medical condition that, in the investigator’s opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
• Class IV New York Heart Association chronic heart failure
• Historical evidence of left ventricular ejection fraction < 35%
• Presence of pulmonary hypertension that, in the investigator’s opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
• Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the patient’s enrollment in this trial
• History of a malignancy within the 5 years prior to screening, with the exception of basal cell or squamous cell skin neoplasms. In addition, a malignant diagnosis or condition that occurred more than 5 years prior to screening, and any basal cell or squamous cell neoplasm must be considered cured, inactive, and not under treatment
• Known post-bronchodilator response in FEV1 and/or FVC >= 12% and >= 200 mL, respectively
• Receipt of an investigational drug within 4 weeks, or 5 half-lives, whichever is longer, prior to screening
• Previous treatment with PRM-151
• Clinically significant abnormality on ECG during screening
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of PRM-151
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method