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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05130970




Registration number
NCT05130970
Ethics application status
Date submitted
12/11/2021
Date registered
23/11/2021

Titles & IDs
Public title
CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
Scientific title
A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary Fibrosis
Secondary ID [1] 0 0
2021 003162 12
Secondary ID [2] 0 0
CSL312_2002
Universal Trial Number (UTN)
Trial acronym
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 - CSL312
Treatment: Drugs - Placebo

Experimental: CSL312 - Administered IV and SC

Placebo comparator: Placebo - Administered IV and SC


Treatment: Drugs: CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody

Treatment: Drugs: Placebo
Same as the CSL312 formulation buffer
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo
Timepoint [1] 0 0
Up to 22 weeks
Primary outcome [2] 0 0
Percent of participants with SAEs for CSL312 or placebo
Timepoint [2] 0 0
Up to 22 weeks
Primary outcome [3] 0 0
Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo
Timepoint [3] 0 0
Up to 22 weeks
Primary outcome [4] 0 0
Percent of participants with AESIs for CSL312 or placebo
Timepoint [4] 0 0
Up to 22 weeks
Primary outcome [5] 0 0
Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs)
Timepoint [5] 0 0
Up to 14 weeks
Primary outcome [6] 0 0
Percent of participants with CSL312 induced ADAs
Timepoint [6] 0 0
Up to 14 weeks
Primary outcome [7] 0 0
Number of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
Timepoint [7] 0 0
Up to 14 weeks
Primary outcome [8] 0 0
Percent of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
Timepoint [8] 0 0
Up to 14 weeks
Secondary outcome [1] 0 0
Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312
Timepoint [1] 0 0
Up to 14 weeks
Secondary outcome [2] 0 0
Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312
Timepoint [2] 0 0
Up to 14 weeks
Secondary outcome [3] 0 0
Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312
Timepoint [3] 0 0
Up to 14 weeks
Secondary outcome [4] 0 0
Area under the plasma concentration-time curve after the first dose interval (AUC0-tau) (last SC dosing interval only) of CSL312
Timepoint [4] 0 0
Up to 14 weeks
Secondary outcome [5] 0 0
Ctrough after intravenous (IV) administration of CSL312
Timepoint [5] 0 0
Up to 8 days
Secondary outcome [6] 0 0
Cmax after IV administration of CSL312
Timepoint [6] 0 0
Up to 8 days
Secondary outcome [7] 0 0
Tmax after IV administration of CSL312
Timepoint [7] 0 0
Up to 8 days
Secondary outcome [8] 0 0
Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312
Timepoint [8] 0 0
Up to 14 weeks
Secondary outcome [9] 0 0
Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312
Timepoint [9] 0 0
Up to 14 weeks

Eligibility
Key inclusion criteria
* Male or female patients = 40 years of age
* Documented diagnosis of IPF
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of clinically significant cardiovascular disease, including myocardial infarction, unstable ischemic heart disease, congestive heart failure, or angina during the 6 months before screening
* Sinoatrial or atrioventricular block, uncontrolled hypertension
* Active bleeding or current clinically significant coagulopathy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/01/2024
Sample size
Target
Accrual to date
Final
81
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
Austria
State/province [15] 0 0
Graz
Country [16] 0 0
Austria
State/province [16] 0 0
Linz
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liège
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Denmark
State/province [20] 0 0
Odense
Country [21] 0 0
Germany
State/province [21] 0 0
Coswig
Country [22] 0 0
Germany
State/province [22] 0 0
Essen
Country [23] 0 0
Germany
State/province [23] 0 0
Hannover
Country [24] 0 0
Germany
State/province [24] 0 0
Wuppertal
Country [25] 0 0
Italy
State/province [25] 0 0
Foggia
Country [26] 0 0
Poland
State/province [26] 0 0
Bialystok
Country [27] 0 0
Poland
State/province [27] 0 0
Nowa Sol
Country [28] 0 0
Poland
State/province [28] 0 0
Wroclaw
Country [29] 0 0
Spain
State/province [29] 0 0
Barcelona
Country [30] 0 0
Spain
State/province [30] 0 0
Cadiz
Country [31] 0 0
United Kingdom
State/province [31] 0 0
MD
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Birmingham
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Londonderry
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
CSL Behring
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?
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at [email protected].

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
Available to whom?
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.

An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.

The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05130970