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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04552899
Other study ID # WA42293
Secondary ID 2020-000791-38
Status Terminated
Phase Phase 3
First received
Last updated
Start date March 19, 2021
Est. completion date February 10, 2023

Study information

Verified date March 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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Study Design


Intervention

Drug:
PRM-151 (Zinpentraxin Alfa)
A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.
Placebo
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

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Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absolute Change in Forced Vital Capacity (FVC [mL]) From Baseline up to Week 52
Secondary Absolute Change in 6-minute Walk Distance (6MWD) From Baseline up to Week 52
Secondary Absolute Change in FVC% Predicted From Baseline up to Week 52
Secondary Time to Disease Progression From Baseline up to 1 year
Secondary Time to First Respiratory-related Hospitalizations From Baseline up to 1 year
Secondary Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) The UCSD-SOBQ is a 24-item questionnaire used to assess dyspnea severity during specific activities (21 items) and limitations caused by dyspnea in daily life (4 items). Items are assessed using a 6-point scale. Total scores, once summed, can range from 0-120 with a higher score reflecting greater dyspnea severity. At Baseline, Week 12, Week 24, Week 36 and Week 52
Secondary Change in St. George Respiratory Questionnaire (SGRQ) Total Score The SGRQ is a 50-item respiratory-specific quality-of-life questionnaire. The questions assess the impact of disease on activity, functionality and symptoms. Each scale is scored from 0-100. A total score represents the weighted average of these three subscores. A lower score indicates best health while a higher score indicates worst health. At Baseline, Week 12, Week 24, Week 36 and Week 52
Secondary Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) From Baseline up to 1 year
Secondary Change in Carbon Monoxide Diffusing Capacity (DLCO) At Baseline, Week 12, Week 24, Week 36 and Week 52
Secondary Survival Survival is measured by all-cause mortality From Baseline up to 1 year
Secondary Percentage of Participants With Adverse Events (AEs) From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Secondary Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Secondary Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Secondary Plasma Concentrations of PRM-151 Days 1, 5 and Weeks 4, 12, and 24
Secondary Prevalence of Anti-drug Antibodies (ADAs) at Baseline At Baseline
Secondary Percentage of Participants With ADAs During the Study Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56
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