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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04594707




Registration number
NCT04594707
Ethics application status
Date submitted
15/10/2020
Date registered
20/10/2020

Titles & IDs
Public 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
Scientific 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)
Secondary ID [1] 0 0
2020-001429-30
Secondary ID [2] 0 0
WA42294
Universal Trial Number (UTN)
Trial acronym
STARSCAPE-OLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRM-151 (Zinpentraxin Alfa)

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

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


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From baseline until 8 weeks after the final dose, an average of 6 months
Primary outcome [2] 0 0
Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest
Timepoint [2] 0 0
From baseline until 8 weeks after the final dose, an average of 6 months
Primary outcome [3] 0 0
Percentage of of Participants Permanently Discontinuing Study Treatment Due to AEs
Timepoint [3] 0 0
From baseline until 8 weeks after the final dose, an average of 6 months
Secondary outcome [1] 0 0
Annual Rate of Change in Forced Vital Capacity (FVC) (mL)
Timepoint [1] 0 0
From baseline until study completion (up to approximately 1.5 years)
Secondary outcome [2] 0 0
Annual Rate of Change in 6-Minute Walk Distance (6MWD)
Timepoint [2] 0 0
From baseline until study completion (up to approximately 1.5 years)
Secondary outcome [3] 0 0
Annual Rate of Change in FVC% Predicted
Timepoint [3] 0 0
From baseline until study completion (up to approximately 1.5 years)
Secondary outcome [4] 0 0
Change in Carbon Monoxide Diffusing Capacity (DLCO)
Timepoint [4] 0 0
At Baseline, Week 24 and Week 48
Secondary outcome [5] 0 0
Time to Disease Progression
Timepoint [5] 0 0
From baseline until study completion (up to approximately 1.5 years)
Secondary outcome [6] 0 0
Survival
Timepoint [6] 0 0
Every 6 Months and at study completion (up to approximately 1.5 years)
Secondary outcome [7] 0 0
IPF-related Mortality
Timepoint [7] 0 0
Every 6 Months and at study completion (up to approximately 1.5 years)
Secondary outcome [8] 0 0
Respiratory-related Mortality
Timepoint [8] 0 0
Every 6 Months and at study completion (up to approximately 1.5 years)
Secondary outcome [9] 0 0
Plasma Concentrations of PRM-151 at Specified Timepoints
Timepoint [9] 0 0
Days 1 and 5, Weeks 4, and 12
Secondary outcome [10] 0 0
Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline
Timepoint [10] 0 0
Baseline (Day 1)
Secondary outcome [11] 0 0
Percentage of Participants With ADAs During the Study
Timepoint [11] 0 0
Weeks 4, 12 and 24

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/02/2023
Sample size
Target
Accrual to date
Final
117
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Cairns Base Hospital; Cancer Care Centre - Cairns
Recruitment hospital [3] 0 0
Lung Research Queensland - Nundah
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Monash Medical Centre; Medicine - Melbourne
Recruitment hospital [6] 0 0
The Alfred Hospital - Prahan
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4101 - Nundah
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3186 - Melbourne
Recruitment postcode(s) [6] 0 0
3181 - Prahan
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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Illinois
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Kansas
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Kentucky
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Szombathely
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Kfar- Saba
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Petach Tiqwa
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Ramat Gan
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Rehovot
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Abruzzo
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Italy
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Campania
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Puglia
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Italy
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Sicilia
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Sariyer

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04594707