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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
Date last updated
9/02/2024

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
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).
Trial website
https://clinicaltrials.gov/study/NCT05130970
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05130970