A Study to Evaluate Safety and Effectiveness of PRM-151 to Treat Patients with Idiopathic Pulmonary Fibrosis

Overview

About this study

The purpose of this study is to confirm the long-term safety, effectiveness, and pharmacokinetics of PRM-151 in the treatment of eligible patients with IPF who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Additionally, patients who have discontinued treatment from or have completed Study WA42293 and do not want to receive open-label PRM-151 in this study, will be invited to enroll in survival follow-up. Patients in Cohort C will not receive any treatment and will not undergo any safety or efficacy assessments during the study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/17/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Eva Carmona Porquera, M.D., Ph.D.

Closed for enrollment

Contact information:

Shannon Daley C.C.R.C., CCRP

(507) 293-0637

Daley.Shannon@mayo.edu

More information

Publications

Publications are currently not available