A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

Key facts

Study ID: NCT04552899
Run by: Hoffmann-La Roche
People needed: 665
Starts: 2021-03-19
Expected to finish: 2023-02-10
Last updated by the study team: 2024-04-18

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 as determined by the over-reader
Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (>) 0.70 during screening determined by the over-reader
Diffusing capacity for carbon monoxide (DLCO) >/= 30% and less than or equal to (</=) 90% of predicted at screening as determined by the over-reader
If receiving pirfenidone or nintedanib treatment for IPF, the participant 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
Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study.
For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception
For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment
For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry

You may not qualify if…

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 prior to or during screening
Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to or during 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 participant 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 that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) on ECG during screening based on the Fridericia correction formula
Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant
Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151
Women of childbearing potential (Only for participants enrolling in Japan)

Where it is running

Banner University Medical Center Phoenix; Main Pharmacy — Phoenix, Arizona, United States
Lovelace Scientific Resources, Inc. — Phoenix, Arizona, United States
UC Irvine Medical Center — Orange, California, United States
Stanford Hospital and Clinics — Palo Alto, California, United States
University of California Davis — Sacramento, California, United States
Inst. of Healthcare Assessment, Inc. — San Diego, California, United States
UCSF Medical Center — San Francisco, California, United States
Paloma Medical Group — San Juan Capistrano, California, United States
William Sansum Diabetes Center — Santa Barbara, California, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) — Aurora, Colorado, United States
National Jewish Health Medical Center — Denver, Colorado, United States
Yale New Haven Hospital — New Haven, Connecticut, United States
Georgetown University Medical Center — Washington D.C., District of Columbia, United States
Meris Clinical Research — Brandon, Florida, United States
Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration — Celebration, Florida, United States
Advanced Pulmonary & Sleep Research Institute of Florida — Daytona Beach, Florida, United States
University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine — Gainesville, Florida, United States
Malcom Randall VA Medical Center — Gainesville, Florida, United States
University of Florida Health Pulmonology - Jacksonville — Jacksonville, Florida, United States
Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States
San Marcus Research Clinic Inc. — Miami, Florida, United States
Renstar Medical Research — Ocala, Florida, United States
Central Florida Pulmonary Group, PA — Orlando, Florida, United States
Sarasota Memorial Health Care System; Cancer Research Program — Sarasota, Florida, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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