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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 : Active, not recruiting
First Posted : October 20, 2020
Last Update Posted : December 19, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE October 15, 2020
First Posted Date  ICMJE October 20, 2020
Last Update Posted Date December 19, 2022
Actual Study Start Date  ICMJE August 30, 2021
Estimated Primary Completion Date December 29, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2020)
  • 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]).
  • 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 ]
  • Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs [ Time Frame: From baseline until 8 weeks after the final dose ]
  • Change from Baseline in Targeted Clinical Laboratory Test Results [ Time Frame: From baseline until 8 weeks after the final dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • Incidence and Severity of 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]).
  • Incidence and Severity of Infusion Related Reactions (IRRs) and other AEs of Special Interest [ Time Frame: From baseline until 8 weeks after the final dose ]
  • Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs [ Time Frame: From baseline until 8 weeks after the final dose ]
  • Change from Baseline in Targeted Clinical Laboratory Test Results [ Time Frame: From baseline until 8 weeks after the final dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2022)
  • Annual Rate of Change in Forced Vital Capacity (FVC) (mL) [ Time Frame: From baseline until study completion (up tp 4 years) ]
  • Annual Rate of Change in 6-Minute Walk Distance (6MWD) [ Time Frame: From baseline until study completion (up tp 4 years) ]
  • Annual Rate of Change in FVC% Predicted [ Time Frame: From baseline until study completion (up tp 4 years) ]
  • Annual Rate of Change in Carbon Monoxide Diffusing Capacity (DLCO) [ Time Frame: From baseline until study completion (up tp 4 years) ]
  • 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
  • Survival [ Time Frame: Every 6 Months and at study completion (up to 4 years) ]
  • IPF-related Mortality [ Time Frame: Every 6 Months and at study completion (up to 4 years) ]
  • Respiratory-related Mortality [ Time Frame: Every 6 Months and at study completion (up to 4 years) ]
  • Plasma Concentrations of PRM-151 at Specified Timepoints [ Time Frame: Days 1, 3 and 5, Weeks 4, 12 and 24 ]
  • Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline [ Time Frame: Baseline (Day 1) ]
  • Percentage of Participants with ADAs During the Study [ Time Frame: Weeks 4, 12 and 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2020)
  • Annual Rate of Decline in Forced Vital Capacity (FVC) (mL) [ Time Frame: From baseline until study completion (up tp 4 years) ]
  • Annual Rate of Change in 6-Minute Walk Distance (6MWD) [ Time Frame: From baseline until study completion (up tp 4 years) ]
  • Annual Rate of Decline in FVC% Predicted [ Time Frame: From baseline until study completion (up tp 4 years) ]
  • Progression-free Survival (PFS) [ Time Frame: Time to first occurrence of a significant FVC decline ]
  • Change from Baseline in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Day 1, Week 24 and then every 24 Weeks thereafter ]
  • Change from Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: Day 1, Week 24 and then every 24 Weeks thereafter ]
  • Change from Baseline in Carbon Monoxide Diffusing Capacity (DLCO) [ Time Frame: Day 1, Week 24 and then every 24 Weeks thereafter ]
  • Survival [ Time Frame: Every 6 Months and at study completion (up to 4 years) ]
  • Serum Concentrations of PRM-151 at Specified Timepoints [ Time Frame: Days 1, 3 and 5, Weeks 4, 12 and 24 ]
  • Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline [ Time Frame: Baseline (Day 1) ]
  • Incidence of ADAs During the Study [ Time Frame: Weeks 4, 12 and 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: PRM-151

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

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

Intervention: Drug: PRM-151 (Zinpentraxin Alfa)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 16, 2022)
117
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2020)
700
Estimated Study Completion Date  ICMJE December 29, 2028
Estimated Primary Completion Date December 29, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   China,   Czechia,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Singapore,   South Africa,   Spain,   Taiwan,   Turkey,   United States
Removed Location Countries Austria,   Brazil,   Peru,   Puerto Rico,   Russian Federation,   Sweden,   Switzerland,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT04594707
Other Study ID Numbers  ICMJE WA42294
2020-001429-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP