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

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ClinicalTrials.gov Identifier: NCT04594707
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : November 30, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: PRM-151 (Zinpentraxin Alfa) Phase 3

Detailed Description:
This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : December 29, 2028
Estimated Study Completion Date : December 29, 2028


Arm Intervention/treatment
Experimental: PRM-151

Corhort A: Participants entering, following participation in study PRM-151-202.

Cohort B: Participants entering, following participation in study WA42293.

Drug: PRM-151 (Zinpentraxin Alfa)

Cohort A: Participants will receive three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks.

Cohort B: Participants previously randomized to the placebo in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses will contain PRM-151. Participants previously randomized to the treatment arm in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses will contain PRM-151, whereas two doses will contain placebo.

Other Name: Zinpentraxin Alfa




Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AE) [ Time Frame: From baseline until 8 weeks after the final dose ]
    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]).

  2. 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 ]
  3. Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs [ Time Frame: From baseline until 8 weeks after the final dose ]
  4. Change from Baseline in Targeted Clinical Laboratory Test Results [ Time Frame: From baseline until 8 weeks after the final dose ]

Secondary Outcome Measures :
  1. Annual Rate of Change in Forced Vital Capacity (FVC) (mL) [ Time Frame: From baseline until study completion (up tp 4 years) ]
  2. Annual Rate of Change in 6-Minute Walk Distance (6MWD) [ Time Frame: From baseline until study completion (up tp 4 years) ]
  3. Annual Rate of Change in FVC% Predicted [ Time Frame: From baseline until study completion (up tp 4 years) ]
  4. Annual Rate of Change in Carbon Monoxide Diffusing Capacity (DLCO) [ Time Frame: From baseline until study completion (up tp 4 years) ]
  5. Time to Disease Progression [ Time Frame: From the time of randomization until disease progression or death (up tp 4 years) ]
    Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death

  6. Survival [ Time Frame: Every 6 Months and at study completion (up to 4 years) ]
  7. IPF-related Mortality [ Time Frame: Every 6 Months and at study completion (up to 4 years) ]
  8. Respiratory-related Mortality [ Time Frame: Every 6 Months and at study completion (up to 4 years) ]
  9. Plasma Concentrations of PRM-151 at Specified Timepoints [ Time Frame: Days 1, 3 and 5, Weeks 4, 12 and 24 ]
  10. Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline [ Time Frame: Baseline (Day 1) ]
  11. Percentage of Participants with ADAs During the Study [ Time Frame: Weeks 4, 12 and 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
  • Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula.
  • Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594707


Contacts
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Contact: Reference Study ID Number: WA42294 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 270 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04594707    
Other Study ID Numbers: WA42294
2020-001429-30 ( EudraCT Number )
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: November 30, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases