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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: 22 February 2021
Main ID:  NCT04552899
Date of registration: 14/09/2020
Prospective Registration: Yes
Primary sponsor: Hoffmann-La Roche
Public title: A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Scientific title: A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis
Date of first enrolment: February 28, 2021
Target sample size: 658
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04552899
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 3
Countries of recruitment
Argentina Australia Austria Belgium Brazil Canada China Czechia
Denmark Finland France Germany Greece Hong Kong Hungary Israel
Italy Korea, Republic of Mexico Netherlands New Zealand Norway Peru Poland
Portugal Russian Federation Singapore South Africa Spain Sweden Switzerland Taiwan
Turkey Ukraine United Kingdom United States
Contacts
Name:     Reference Study ID Number: WA42293 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:

- Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European
Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic
Society (ALAT) Clinical Practice Guideline

- High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of
IPF, confirmed by central review of Chest HRCT and central review of any available
lung biopsy (LB)

- Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at
sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining
oxygen saturation of greater than or equal to (>/= )83% during the 6 minute walk test
(6MWT) during screening

- FVC >/= 45% predicted during screening

- Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (>) 0.70 during
screening

- Diffusing capacity for carbon monoxide (DLCO) >/= 30% and less than or equal to ( 90% of predicted at screening

- If receiving pirfenidone or nintedanib treatment for IPF, the patient must have been
on treatment for at least 3 months and a stable dose for at least 4 weeks prior to
screening, and during screening

- If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve
or having previously taken and discontinued) must have discontinued such treatment >/=
4 weeks prior to screening and during screening

- Anticipated life expectancy of at least 12 months at baseline

- Patient and investigator considered all medicinal treatment options and/or possibly
lung transplantation prior to considering participation in the study.

Exclusion Criteria:

- Evidence of other known causes of Interstitial Lung Disease (ILD)

- FVC% predicted value showing repeated increase in the 6 months period prior to
screening and including screening value

- Emphysema present on greater than or equal to (>/=) 50% of the HRCT, or the extent of
emphysema is greater than the extent of fibrosis, according to central review of the
HRCT

- Receiving nintedanib in combination with pirfenidone

- Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist
agents (including but not limited to methotrexate, azathioprine, mycophenolate
mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks
of screening

- Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent
within 2 weeks prior to screening

- Acute respiratory or systemic bacterial, viral, or fungal infection either during
screening or prior to screening and not successfully resolved 4 weeks prior to
screening visit

- Participants with active or latent tuberculosis (confirmed within the 6 months prior
to or during screening, by a positive screening test [interferon gamma release assay])

- Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea
level and up to 6 L/min at altitude (>/= 5000 feet [1524 meters] above sea level)
during screening

- Class IV New York Heart Association chronic heart failure

- Historical evidence of left ventricular ejection fraction < 35%

- Presence of pulmonary hypertension that, in the investigator's opinion, would
substantially limit the ability to comply with study requirements or may influence any
of the safety or efficacy assessments included in the study

- Cardiopulmonary rehabilitation program based on exercise training that has been
completed within 8 weeks prior to screening or planned to start during the patient's
enrollment in this trial

- History of smoking, alcohol or substance abuse disorder, or a malignancy

- Previous treatment with PRM-151

- Clinically significant abnormality on ECG during screening 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 participant



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Idiopathic Pulmonary Fibrosis
Intervention(s)
Drug: Placebo
Drug: PRM-151
Primary Outcome(s)
Absolute Change in Forced Vital Capacity (FVC [mL]) [Time Frame: From Baseline up to Week 52]
Secondary Outcome(s)
Absolute Change in 6-minute Walk Distance (6MWD) [Time Frame: From Baseline up to Week 52]
Absolute Change in FVC% Predicted [Time Frame: From Baseline up to Week 52]
Change from Baseline in Targeted Clinical Laboratory Test Results [Time Frame: From Baseline up to 2.5 years]
Change in Carbon Monoxide Diffusing Capacity (DLCO) [Time Frame: From Baseline up to Week 52]
Change in St. George Respiratory Questionnaire (SGRQ) Total Score [Time Frame: From Baseline up to Week 52]
Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) [Time Frame: From Baseline up to Week 52]
Percentage of Participants Permanently Discontinuing Study Treatment due to AEs [Time Frame: From Baseline up to 2.5 years]
Percentage of Participants with ADAs During the Study [Time Frame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56]
Percentage of Participants with Adverse Events (AEs) [Time Frame: From Baseline up to 2.5 years]
Percentage of Participants with Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest [Time Frame: From Baseline up to 2.5 years]
Plasma Concentrations of PRM-151 [Time Frame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56]
Prevalence of Anti-drug Antibodies (ADAs) at Baseline [Time Frame: Day 1]
Progression-free Survival (PFS) [Time Frame: From Baseline up to 2.5 years]
Survival [Time Frame: From Baseline up to 2.5 years]
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) [Time Frame: From Baseline up to 2.5 years]
Time to First Respiratory-related Hospitalizations [Time Frame: From Baseline up to 2.5 years]
Secondary ID(s)
2020-000791-38
WA42293
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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