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)

• ClinicalTrials.gov Identifier: NCT04594707
• Recruitment Status: Terminated
• First Posted: October 20, 2020
• Last Update Posted: March 17, 2023
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: October 15, 2020
• First Posted Date: October 20, 2020
• Last Update Posted Date: March 17, 2023
• Actual Study Start Date: August 30, 2021
• Actual Primary Completion Date: February 10, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: 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: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

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

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 16, 2022): 117
• Original Estimated Enrollment (submitted: October 15, 2020): 700
• Actual Study Completion Date: February 10, 2023
• Actual Primary Completion Date: February 10, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT04594707
• Other Study ID Numbers: 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

• 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: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: March 2023