Clinical Trials List
2021-03-01 - 2028-12-31
Phase III
Recruiting7
A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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Sponsor
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Trial scale
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
This trial will evaluate the long-term safety, efficacy, and pharmacokinetics of open-label PRM-151 in patients with idiopathic pulmonary fibrosis (IPF).
The efficacy goals are to assess the long-term efficacy of 10 mg/kg PRM-151 plus SOC (excluding lung transplantation) administered intravenously every 4 weeks, based on the following indicators:
• Annual rate of decline in forced vital capacity (FVC [mL])
• Annual rate of change in 6-minute walk distance (6MWD)
• Annual rate of decline in predicted FVC%
• Worsening-free survival, defined as the time elapsed until the first occurrence of an absolute decline of 10% in predicted FVC%, a relative decline of 15% in 6MWD, or death
• Change in the University of California, San Diego Dyspnea Questionnaire (UCSD-SOBQ) since baseline
• Change in the total score of the St. George Respiratory Questionnaire (SGRQ) since baseline
• Change in diffuse carbon monoxide (DLCO) since baseline
• Survival as a measure of mortality from all causes
Inclution Criteria
Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Exclusion Criteria
Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
History of smoking within 3 months prior to the first visit in the OLE.
History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
History of severe allergic reaction or anaphylactic reaction to PRM-151.
Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula.
Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
700 participants
