PRM-151-202:  A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

​Eligibility Criteria:

The following information is provided as a guide to investigators.  Inclusion and exclusion criteria can be complex and requires the study physician to review each potential subject's eligibility individually. To learn if you are eligible for this study, it is important that you contact the study research staff at a study site. Find an open study site here.

Inclusion Criteria

  • Between 40 to 80 years of age at the time of signing the informed consent.
  • Diagnosis of IPF satisfying the ATS/ERS/JRS/ALAT diagnostic criteria.
  • If on pirfenidone or nintedanib subject must be on stable dose for at least 3 months without improvement in FVC% predicted on 2 consecutive PFT's. May not be on both pirfenidone and nintedanib.
  • If not currently recieving pirfenidone or nintedanib , must have been off these drugs for >​ 4 weeks before baseline visit.
  • Meet pulmonary function testing (PFT) requirements:
    • FVC > 50% predicted and < 90% predicted at screening.
    • DLCO > 25% and <90% predicted at screening.
    • FEV1/FVC ratio >0.7
  • Minimum distance of 150 meters on 6MWT (with or without supplemental oxygen)
  • Women of child bearing potential must have negative serum pregnancy test and agree to utilize adequate methods of contraception as outlined in the protocol.
  • Have a life expectancy of at least 9 months as judged by the investigator.
  • According to the investigator's judgement can comply with the requirements of the protocol.
  • Provide written informed consent to participate in the study.

Exclusion Criteria

  •  Baseline resting oxygen saturation <89% on room air or on supplemental oxygen
  • Emphysema >50% on HRCT or the extent of emphysema is greater than fibrosis according to reported results of most recent HRCT.
  • History of cigarette smoking within the previous 3 months.
  • Received investigational therapy for IPF within 4 weeks before baseline visit.
  • Receiving systemic corticosteroids equivalent to prednisone >10 mg/day or equivalent within 2 weeks of baseline visit.
  • Received azathioprine, cyclophosphamide, or cyclosporine A within 4 weeks of baseline visit.
  • History of malignancy within the previous 5 years - with the exception of basal cell skin neoplasms.  A malignant condition or diagnosis first occurring prior to 5 years must be considered cured, inactive, and not under current treatment.
  • Has a known post-bronchodilator increase in FEV1 of >10% or FVC of >7.5%
  • Unable to refrain for use of short acting bronchodilators within 12 hours of PFT's, DLCO and 6MWT.
  • Unable to refrain for use of long acting bronchodilators within 24 hours of PFT's, DLCO and 6MWT.
  • Pregnant or lactating females.