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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT04594707
Date of registration: 15/10/2020
Prospective Registration: Yes
Primary sponsor: Hoffmann-La Roche
Public title: A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Scientific title: A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Date of first enrolment: January 29, 2021
Target sample size: 700
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04594707
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Reference Study ID Number: WA42294 www.roche.com/about_roche/roche_worldwide.htm
Address: 
Telephone: 888-662-6728 (U.S. and Canada)
Email: global-roche-genentech-trials@gene.com
Affiliation: 
Name:     Clinical Trials
Address: 
Telephone:
Email:
Affiliation:  Hoffmann-La Roche
Key inclusion & exclusion criteria

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 including
prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on
the Fridericia correction formula; or laboratory tests (hematology, serumchemistry,
and urinalysis) that, in the opinion of the investigator, may pose an additional risk
in administering study drug to the participant.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Idiopathic Pulmonary Fibrosis
Intervention(s)
Drug: PRM-151
Primary Outcome(s)
Change from Baseline in Targeted Clinical Laboratory Test Results [Time Frame: From baseline until 8 weeks after the final dose]
Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs [Time Frame: From baseline until 8 weeks after the final dose]
Percentage of Participants with Adverse Events (AE) [Time Frame: From baseline until 8 weeks after the final dose]
Percentage of Participants with Infusion Related Reactions (IRRs) and other AEs of Special Interest [Time Frame: From baseline until 8 weeks after the final dose]
Secondary Outcome(s)
Annual Rate of Change in 6-Minute Walk Distance (6MWD) [Time Frame: From baseline until study completion (up tp 4 years)]
Annual Rate of Decline in Forced Vital Capacity (FVC) (mL) [Time Frame: From baseline until study completion (up tp 4 years)]
Annual Rate of Decline in FVC% Predicted [Time Frame: From baseline until study completion (up tp 4 years)]
Change from Baseline in Carbon Monoxide Diffusing Capacity (DLCO) [Time Frame: Day 1, Week 24 and then every 24 Weeks thereafter]
Change from Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score [Time Frame: Day 1, Week 24 and then every 24 Weeks thereafter]
Change from Baseline in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) [Time Frame: Day 1, Week 24 and then every 24 Weeks thereafter]
Percentage of Participants with ADAs During the Study [Time Frame: Weeks 4, 12 and 24]
Plasma Concentrations of PRM-151 at Specified Timepoints [Time Frame: Days 1, 3 and 5, Weeks 4, 12 and 24]
Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline [Time Frame: Baseline (Day 1)]
Progression-free Survival (PFS) [Time Frame: Time to first occurrence of a significant FVC decline]
Survival [Time Frame: Every 6 Months and at study completion (up to 4 years)]
Secondary ID(s)
2020-001429-30
WA42294
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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