A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis

Phase 1

• Conditions: Idiopathic pulmonary fibrosis (IPF); MedDRA version: 21.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001429-30-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Taken part in a previous study of PRM-151, as follows:
o Participated in Study PRM-151-202, and tolerated the study drug in the opinion of the investigator OR
o Completed study treatment in Study WA42293 OR
o Participated in Study WA42293 but have discontinued from study treatment
• 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
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

• Received any experimental treatment other than PRM-151 within 4 weeks or five half-lives of the experimental drug, whichever is longer, prior to the first dose in the OLE study
• 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 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 including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula; or laboratory tests (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient

Study & Design

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