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History of Changes for Study: NCT04552899
A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis
Latest version (submitted September 14, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 16, 2020 None (earliest Version on record)
2 October 5, 2020 Oversight, Study Status, Eligibility, Outcome Measures, Study Description and Study Identification
3 November 3, 2020 Recruitment Status, Study Status and Contacts/Locations
4 December 18, 2020 Study Status, Contacts/Locations, Eligibility and Outcome Measures
5 February 12, 2021 Contacts/Locations and Study Status
6 March 11, 2021 Study Status and Contacts/Locations
7 April 8, 2021 Study Status and Contacts/Locations
8 May 6, 2021 Contacts/Locations and Study Status
9 June 4, 2021 Contacts/Locations and Study Status
10 June 29, 2021 Contacts/Locations and Study Status
11 July 29, 2021 Contacts/Locations and Study Status
12 August 25, 2021 Contacts/Locations and Study Status
13 September 23, 2021 Contacts/Locations and Study Status
14 October 22, 2021 Contacts/Locations and Study Status
15 November 16, 2021 Contacts/Locations and Study Status
16 November 19, 2021 Contacts/Locations, Study Status and Study Identification
17 December 3, 2021 Contacts/Locations and Study Status
18 January 4, 2022 Contacts/Locations and Study Status
19 February 2, 2022 Contacts/Locations and Study Status
20 February 22, 2022 Contacts/Locations and Study Status
21 March 9, 2022 Contacts/Locations and Study Status
22 April 4, 2022 Contacts/Locations and Study Status
23 April 25, 2022 Contacts/Locations and Study Status
24 May 9, 2022 Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Description
25 May 18, 2022 Eligibility and Study Status
26 June 8, 2022 Study Status
27 July 1, 2022 Contacts/Locations and Study Status
28 July 21, 2022 Contacts/Locations and Study Status
29 August 17, 2022 Contacts/Locations and Study Status
30 September 14, 2022 Contacts/Locations and Study Status
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Study NCT04552899
Submitted Date:  September 16, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: WA42293
Brief Title: A Study to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis
Official 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
Secondary IDs: 2020-000791-38 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2020
Overall Status: Not yet recruiting
Study Start: October 10, 2020
Primary Completion: February 15, 2023 [Anticipated]
Study Completion: April 15, 2023 [Anticipated]
First Submitted: September 14, 2020
First Submitted that
Met QC Criteria:
September 16, 2020
First Posted: September 17, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
September 16, 2020
Last Update Posted: September 17, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: This Phase III Study will Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of PRM-151 Compared with Placebo in Participants with Idiopathic Pulmonary Fibrosis (IPF).
Detailed Description:
Open or close this module Conditions
Conditions: Idiopathic Pulmonary Fibrosis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 658 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PRM-151
Participants will receive intravenous (IV) infusions of PRM-151 over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.
Drug: PRM-151
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 Comparator: Placebo
Participants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Drug: Placebo
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Absolute Change in Forced Vital Capacity (FVC [mL])
[ Time Frame: From Baseline up to Week 52 ]

Secondary Outcome Measures:
1. Absolute Change in 6-minute Walk Distance (6MWD)
[ Time Frame: From Baseline up to Week 52 ]

6MWD is the distance covered by the patient during the 6-minute walk test.
2. Absolute Change in FVC% Predicted
[ Time Frame: From Baseline up to Week 52 ]

3. Progression-free Survival (PFS)
[ Time Frame: From Baseline up to 2.5 years ]

PFS is defined as the time to first occurrence of >= 10% absolute decline in % predicted FVC, >= 15% relative decline in 6MWD, or death
4. Time to First Respiratory-related Hospitalizations
[ Time Frame: From Baseline up to 2.5 years ]

Respiratory-related Hospitalizations are defined as non-elective hospitalizations due to any respiratory cause, including acute exacerbations of IPF, or suspected acute exacerbations of IPF, as determined by Adjudication Committee)
5. Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
[ Time Frame: From Baseline up to Week 52 ]

The UCSD-SOBQ consists of 24 questions in 2 domains: to assess dyspnea severity during specific activities (21 items) and limitations caused by dyspnea in daily life (4 items). Each questions is assessed using a 6-point Likert scale and summed to produce a total score ranging from 0-120. Higher scores reflect greater dyspnea severity.
6. Change in St. George Respiratory Questionnaire (SGRQ) Total Score
[ Time Frame: From Baseline up to Week 52 ]

The SGRQ consists of 50 questions in 3 domains: the impact of disease on symptoms (severity of respiratory symptoms), activity (impariment in participant activity), and functionality (effects of respiratory symptoms on overall function and well-being). Each scale is scored from 0 to 100, and a total score represents the weighted average of these three subscores. Items are assessed on various response scales, including a 5-point Likert scale and a true/false scale. The SGRQ has a recall period of the past 4 weeks.
7. Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
[ Time Frame: From Baseline up to 2.5 years ]

8. Change in Carbon Monoxide Diffusing Capacity (DLCO)
[ Time Frame: From Baseline up to Week 52 ]

9. Survival
[ Time Frame: From Baseline up to 2.5 years ]

Survivial is measured by all-cause mortality
10. Incidence and Severity of Adverse Events (AEs)
[ Time Frame: From Baseline up to 2.5 years ]

Severity will be determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0].
11. Incidence and Severity of Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest
[ Time Frame: From Baseline up to 2.5 years ]

12. Percentage of Participants Permanently Discontinuing Study Treatment due to AEs
[ Time Frame: From Baseline up to 2.5 years ]

13. Change from Baseline in Targeted Clinical Laboratory Test Results
[ Time Frame: From Baseline up to 2.5 years ]

14. Serum Concentrations of PRM-151
[ Time Frame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56 ]

15. Prevalence of Anti-drug Antibodies (ADAs) at Baseline
[ Time Frame: Day 1 ]

16. Incidence of ADAs During the Study
[ Time Frame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56 ]

Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 85 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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 (Hemoglobin (Hgb) corrected or uncorrected)
  • 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. If the patient is on a lung transplant list, the investigator anticipates the patient will be able to complete the study prior to transplant
  • For patients enrolled in the extended China enrollment phase at NMPA-recognized sites: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry

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
  • 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 either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
  • 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
  • Co-existing acute or chronic medical condition 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
  • Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction < 35%
  • Presence of pulmonary hypertension
  • 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
  • Known post-bronchodilator response in FEV1 and/or FVC >= 12% and >= 200 mL, respectively
  • Receipt of an investigational drug within 4 weeks, or 5 half-lives, whichever is longer, prior to screening
  • Previous treatment with PRM-151
Open or close this module Contacts/Locations
Central Contact Person: Reference Study ID Number: WA42293 www.roche.com/about_roche/roche_worldwide.htm
Telephone: 888-662-6728 (U.S. and Canada)
Email: global-roche-genentech-trials@gene.com
Study Officials: Clinical Trials
Study Director
Hoffmann-La Roche
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Supporting Information:
Time Frame:
Access Criteria:
URL:
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Citations:
Links:
Available IPD/Information:

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