Back to resultsCSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CSL312
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Male or female patients ≥ 40 years of age
- Documented diagnosis of IPF
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
Sites / Locations
- The University of Alabama at Birmingham
- Pulmonary Associates Clinical Trials AZ
- National Institute of Clinical Research
- University of Southern California - Center for Advanced Lung Disease
- University of California Irvine
- Meris Clinical Research
- Lakes Research
- Reliant Medical Research
- US Associates in Research LLC
- Renstar Medical Research
- Central Florida Pulmonary Group, PA
- University of Kansas Medical Center
- Jadestone Clinical Research
- Hannibal Clinic
- Weill Cornell Medical Center
- Superior Clinical Research
- Southeastern Research Center
- University of Cincinnati
- University of Oklahoma Health Sciences Center
- Temple University TMS
- Clinical Trial Center of Middle Tennesse
- Elite Medical Research
- Southwest Family Medicine Associates
- Baylor Scott and White Health - Advanced Lung Disease Specialists
- Baylor College of Medicine
- Royal Adelaide Hospital
- Medizinische Univerität Graz
- Kepler Universitätsklinikum
- Universitair Ziekenhuis (UZ) Leuven
- Centre Hospitalier Universitaire Sart Tilman
- St. Joseph's Healthcare Hamilton
- Dr. Syed Anees Medicine Professional Corporation
- Odense Universitetshospital - Lungemedicinsk Forskningsenhed
- Fachkrankenhaus Coswig GmbH
- Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)
- Medizinische Hochschule Hannover - Klinik für Pneumologie
- Petrus Krankenhaus Wuppertal
- Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia
- Centrum Medycyny Oddechowej Bialymstoku
- Twoja Przychodnia Centrum Medyczne Nowa Sol
- Centrum Badań Klinicznych NZOZ
- Giromed Institute, SLP
- Hospital Universitario Puerta del Mar (HUPM)
- The Churchill Hospital - Oxford University Hospitals NHS Trust
- Queen Elizabeth Hospital
- Altnagelvin Area Hospital
- Manchester Univ NHS - Wythenshawe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CSL312
Placebo
Arm Description
Administered IV and SC
Administered IV and SC
Outcomes
Primary Outcome Measures
Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo
Percent of participants with SAEs for CSL312 or placebo
Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo
Percent of participants with AESIs for CSL312 or placebo
Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs)
Percent of participants with CSL312 induced ADAs
Number of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
Percent of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
Secondary Outcome Measures
Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312
Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312
Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312
Area under the plasma concentration-time curve after the first dose interval (AUC0-tau) (last SC dosing interval only) of CSL312
Ctrough after intravenous (IV) administration of CSL312
Cmax after IV administration of CSL312
Tmax after IV administration of CSL312
Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312
Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05130970
Brief Title
CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
Official Title
A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 27, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CSL312
Arm Type
Experimental
Arm Description
Administered IV and SC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered IV and SC
Intervention Type
Drug
Intervention Name(s)
CSL312
Other Intervention Name(s)
Factor XIIa antagonist monoclonal antibody, Garadacimab
Intervention Description
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Same as the CSL312 formulation buffer
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo
Time Frame
Up to 22 weeks
Title
Percent of participants with SAEs for CSL312 or placebo
Time Frame
Up to 22 weeks
Title
Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo
Time Frame
Up to 22 weeks
Title
Percent of participants with AESIs for CSL312 or placebo
Time Frame
Up to 22 weeks
Title
Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs)
Time Frame
Up to 14 weeks
Title
Percent of participants with CSL312 induced ADAs
Time Frame
Up to 14 weeks
Title
Number of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
Time Frame
Up to 14 weeks
Title
Percent of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
Time Frame
Up to 14 weeks
Secondary Outcome Measure Information:
Title
Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312
Time Frame
Up to 14 weeks
Title
Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312
Time Frame
Up to 14 weeks
Title
Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312
Time Frame
Up to 14 weeks
Title
Area under the plasma concentration-time curve after the first dose interval (AUC0-tau) (last SC dosing interval only) of CSL312
Time Frame
Up to 14 weeks
Title
Ctrough after intravenous (IV) administration of CSL312
Time Frame
Up to 8 days
Title
Cmax after IV administration of CSL312
Time Frame
Up to 8 days
Title
Tmax after IV administration of CSL312
Time Frame
Up to 8 days
Title
Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312
Time Frame
Up to 14 weeks
Title
Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312
Time Frame
Up to 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥ 40 years of age
Documented diagnosis of IPF
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Pulmonary Associates Clinical Trials AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
National Institute of Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
University of Southern California - Center for Advanced Lung Disease
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Meris Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Lakes Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Reliant Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
US Associates in Research LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Central Florida Pulmonary Group, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Jadestone Clinical Research
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Hannibal Clinic
City
Hannibal
State/Province
Missouri
ZIP/Postal Code
63401
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Superior Clinical Research
City
Smithfield
State/Province
North Carolina
ZIP/Postal Code
27577
Country
United States
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Temple University TMS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Clinical Trial Center of Middle Tennesse
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Elite Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Southwest Family Medicine Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor Scott and White Health - Advanced Lung Disease Specialists
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Medizinische Univerität Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Kepler Universitätsklinikum
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Universitair Ziekenhuis (UZ) Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Dr. Syed Anees Medicine Professional Corporation
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Odense Universitetshospital - Lungemedicinsk Forskningsenhed
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Fachkrankenhaus Coswig GmbH
City
Coswig
ZIP/Postal Code
01640
Country
Germany
Facility Name
Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)
City
Essen
ZIP/Postal Code
45239
Country
Germany
Facility Name
Medizinische Hochschule Hannover - Klinik für Pneumologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Petrus Krankenhaus Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Facility Name
Centrum Medycyny Oddechowej Bialymstoku
City
Białystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Twoja Przychodnia Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Facility Name
Centrum Badań Klinicznych NZOZ
City
Wrocław
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Giromed Institute, SLP
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar (HUPM)
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
The Churchill Hospital - Oxford University Hospitals NHS Trust
City
Oxford
State/Province
MD
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Facility Name
Altnagelvin Area Hospital
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
Facility Name
Manchester Univ NHS - Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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 clinicaltrials@cslbehring.com.
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
Learn more about this trial
CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
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