History of Changes for Study: NCT05130970

CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

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Study Record Versions

Version	Submitted Date	Changes
1	November 12, 2021	None (earliest Version on record)
2	December 2, 2021	Study Status
3	December 16, 2021	Contacts/Locations and Study Status
4	January 13, 2022	Study Status and Contacts/Locations
5	February 14, 2022	Recruitment Status, Contacts/Locations, Study Status and Oversight
6	March 11, 2022	Study Status
7	March 30, 2022	Contacts/Locations and Study Status
8	April 8, 2022	Study Status and Contacts/Locations
9	April 12, 2022	Contacts/Locations and Study Status
10	May 12, 2022	Study Status and Contacts/Locations
11	May 19, 2022	Contacts/Locations and Study Status
12	June 22, 2022	Study Status and Contacts/Locations
13	July 14, 2022	Study Status
14	July 26, 2022	Contacts/Locations and Study Status
15	August 3, 2022	Study Status and Contacts/Locations
16	August 10, 2022	Study Status
17	August 12, 2022	Contacts/Locations and Study Status
18	September 8, 2022	Study Status and Contacts/Locations
19	September 19, 2022	Contacts/Locations and Study Status
20	September 21, 2022	Contacts/Locations and Study Status
21	September 29, 2022	Contacts/Locations and Study Status
22	November 8, 2022	Contacts/Locations and Study Status
23	November 28, 2022	Contacts/Locations and Study Status
24	November 29, 2022	Contacts/Locations and Study Status
25	January 12, 2023	Study Status
26	January 18, 2023	Study Status
27	February 1, 2023	Study Status and Contacts/Locations
28	March 28, 2023	Contacts/Locations and Study Status
29	May 25, 2023	Contacts/Locations and Study Status
30	June 5, 2023	Study Status
31	July 10, 2023	Study Status and Contacts/Locations
32	August 21, 2023	Recruitment Status, Study Status and Contacts/Locations
33	September 18, 2023	Study Status
34	October 12, 2023	Study Status
35	November 9, 2023	Study Status
36	December 11, 2023	Study Status
37	January 18, 2024	Study Status
38	February 7, 2024	Recruitment Status, Study Status and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CSL312_2002
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
Secondary IDs:	2021 003162 12 [EudraCT Number]

Study Status


Record Verification:	November 2021
Overall Status:	Not yet recruiting
Study Start:	January 2022
Primary Completion:	July 2023 [Anticipated]
Study Completion:	July 2023 [Anticipated]

First Submitted:	November 12, 2021
First Submitted that Met QC Criteria:	November 12, 2021
First Posted:	November 23, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	November 12, 2021
Last Update Posted:	November 23, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	CSL Behring
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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).
Detailed Description:

Conditions


Conditions:	Idiopathic Pulmonary Fibrosis
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	80 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: CSL312 Administered IV and SC	Drug: CSL312 Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody Other Names: Factor XIIa antagonist monoclonal antibody Garadacimab
Placebo Comparator: Placebo Administered IV and SC	Drug: Placebo Same as the CSL312 formulation buffer

Outcome Measures


Primary Outcome Measures:
1.	Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
2.	Percent of participants with SAEs for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
3.	Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
4.	Percent of participants with AESIs for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
5.	Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs) [ Time Frame: Up to 14 weeks ]
6.	Percent of participants with CSL312 induced ADAs [ Time Frame: Up to 14 weeks ]
7.	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 ]
8.	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 Measures:
1.	Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312 [ Time Frame: Up to 14 weeks ]
2.	Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312 [ Time Frame: Up to 14 weeks ]
3.	Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312 [ Time Frame: Up to 14 weeks ]
4.	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 ]
5.	Ctrough after intravenous (IV) administration of CSL312 [ Time Frame: Up to 8 days ]
6.	Cmax after IV administration of CSL312 [ Time Frame: Up to 8 days ]
7.	Tmax after IV administration of CSL312 [ Time Frame: Up to 8 days ]
8.	Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312 [ Time Frame: Up to 14 weeks ]
9.	Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312 [ Time Frame: Up to 14 weeks ]

Eligibility


Minimum Age:	40 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Trial Registration Coordinator Telephone: +1 610-878-4000 Email: clinicaltrials@cslbehring.com
Study Officials:	Study Director Study Director CSL Behring
Locations:

IPDSharing


Plan to Share IPD:	Yes 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.
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP)
	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.
	Access Criteria:
	URL:

References


Citations:
Links:
Available IPD/Information: