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History of Changes for Study: NCT04739059
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
Latest version (submitted May 7, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 1, 2021 None (earliest Version on record)
2 March 18, 2021 Study Status and Contacts/Locations
3 March 31, 2021 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 April 6, 2021 Contacts/Locations and Study Status
5 April 16, 2021 Contacts/Locations and Study Status
6 May 5, 2021 Study Status
7 May 28, 2021 Outcome Measures and Study Status
8 June 2, 2021 Study Status and Contacts/Locations
9 June 8, 2021 Contacts/Locations and Study Status
10 June 14, 2021 Contacts/Locations and Study Status
11 July 1, 2021 Contacts/Locations and Study Status
12 July 2, 2021 Contacts/Locations and Study Status
13 July 19, 2021 Contacts/Locations and Study Status
14 August 2, 2021 Study Status and Contacts/Locations
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21 August 17, 2021 Contacts/Locations and Study Status
22 August 19, 2021 Contacts/Locations and Study Status
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24 August 26, 2021 Contacts/Locations and Study Status
25 September 15, 2021 Study Status
26 September 28, 2021 Contacts/Locations and Study Status
27 October 4, 2021 Contacts/Locations and Study Status
28 October 11, 2021 Contacts/Locations and Study Status
29 October 18, 2021 Contacts/Locations and Study Status
30 October 28, 2021 Contacts/Locations and Study Status
31 November 2, 2021 Contacts/Locations and Study Status
32 November 4, 2021 Contacts/Locations and Study Status
33 November 10, 2021 Contacts/Locations and Study Status
34 November 15, 2021 Contacts/Locations and Study Status
35 November 16, 2021 Contacts/Locations and Study Status
36 November 22, 2021 Contacts/Locations and Study Status
37 November 30, 2021 Contacts/Locations and Study Status
38 December 1, 2021 Study Status and Contacts/Locations
39 December 2, 2021 Contacts/Locations and Study Status
40 December 8, 2021 Contacts/Locations and Study Status
41 December 14, 2021 Contacts/Locations and Study Status
42 December 17, 2021 Contacts/Locations and Study Status
43 January 10, 2022 Contacts/Locations and Study Status
44 January 18, 2022 Contacts/Locations and Study Status
45 February 2, 2022 Contacts/Locations and Study Status
46 March 11, 2022 Contacts/Locations and Study Status
47 April 7, 2022 Study Status and Contacts/Locations
48 April 14, 2022 Contacts/Locations and Study Status
49 May 12, 2022 Study Status
50 June 9, 2022 Study Status
51 July 4, 2022 Study Status
52 July 28, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
53 August 2, 2022 Study Status
54 September 6, 2022 Study Status
55 September 19, 2022 Study Status
56 September 30, 2022 Arms and Interventions and Study Status
57 October 14, 2022 Study Status
58 November 2, 2022 Outcome Measures, Arms and Interventions and Study Status
59 January 12, 2023 Study Status
60 February 1, 2023 Study Status
61 March 1, 2023 Study Status
62 March 28, 2023 Study Status
63 April 4, 2023 Study Status
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65 June 21, 2023 Study Status
66 July 26, 2023 Study Status
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68 September 18, 2023 Study Status
69 October 12, 2023 Study Status
70 October 30, 2023 Study Status
71 November 9, 2023 Study Status
72 December 7, 2023 Study Status
73 January 18, 2024 Study Status
74 February 13, 2024 Study Status
75 March 21, 2024 Study Status
76 April 4, 2024 Study Status
77 May 7, 2024 Study Status
Comparison Format:
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Study NCT04739059
Submitted Date:  February 1, 2021 (v1)
Open or close this module Study Identification
Unique Protocol ID: CSL312_3002
Brief Title: Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
Official Title: An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
Secondary IDs: 2020-003918-12 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2021
Overall Status: Not yet recruiting
Study Start: March 2021
Primary Completion: September 2023 [Anticipated]
Study Completion: September 2023 [Anticipated]
First Submitted: February 1, 2021
First Submitted that
Met QC Criteria:		 February 1, 2021
First Posted: February 4, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 February 1, 2021
Last Update Posted: February 4, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: CSL Behring
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)
Detailed Description:
Open or close this module Conditions
Conditions: Hereditary Angioedema
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody administered subcutaneously
 Biological: CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • garadacimab
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of subjects with treatment emergent adverse events (TEAEs)
[ Time Frame: Up to 32 months ]
2. Percentage of subjects with TEAEs
[ Time Frame: Up to 32 months ]
3. TEAEs rates per injection
[ Time Frame: Up to 32 months ]
4. TEAEs rates per subject year
[ Time Frame: Up to 32 months ]
Secondary Outcome Measures:
1. The time-normalized number (per month and year) of Hereditary Angioedema (HAE attacks) for the entire study
[ Time Frame: Up to 34 months ]
2. The percentage reduction and the number of subjects experiencing at least ≥ 50% ≥ 70%, ≥ 90 or equal to 100% (attack free) reduction in the time-normalized number of HAE attacks on Treatment compared to Run-in Period
[ Time Frame: Up to 34 months ]
3. The time-normalized number (per month and year) of HAE attacks requiring on-demand treatment in subjects on treatment
[ Time Frame: Up to 32 months ]
4. The time-normalized number (per month and year) of moderate and/or severe HAE attacks in subjects on treatment
[ Time Frame: Up to 32 months ]
5. Number and percentage of subjects rating their response to therapy as good or excellent
[ Time Frame: Up to 32 months ]
6. The number and percentage of subjects experiencingTEAEs with CSL312 or while on placebo
[ Time Frame: Up to 32 months ]
7. The number and percentage of subjects experiencing adverse events of special interest (AESIs) with CSL312 or while on placebo
[ Time Frame: Up to 32 months ]
8. The number and percentage of subjects experiencing TEAEs for naïve C1-INH subjects only with CSL312 or while on placebo
[ Time Frame: Up to 32 months ]
9. The number and percentage of subjects experiencing serious adverse events (SAEs), including deaths, with CSL312 or while on placebo
[ Time Frame: Up to 32 months ]
10. The number and percentage of subjects experiencing CSL312 induced anti-CSL312 antibodies with CSL312 or while on placebo
[ Time Frame: Up to 32 months ]
Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Males and females aged ≥ 12 years
  • Diagnosed with clinically confirmed C1-INH HAE
  • Experienced ≥ 3 HAE attacks during the 3 months before Screening
  • Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
  • Experienced at least an average of 1 HAE attack per month during the Run-in Period

Exclusion Criteria:

  • Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria
  • Use of C1-INH products, androgens, antifibrinolytics or other small molecule medications for routine prophylaxis against HAE attacks at least 2 weeks before the first day of the Run-in Period
  • Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first day of the Run-in Period.
  • Female subjects use estrogen-containing oral contraceptives or hormone replacement therapy within 4 weeks prior to screening
  • Female or male subjects who are fertile and sexually active not using or not willing to use an acceptable method of contraception to avoid pregnancy during the study and for 30 days after receipt of the last dose of CSL312
  • Pregnant, breastfeeding, or not willing to cease breastfeeding
Open or close this module Contacts/Locations
Central Contact Person: Trial Registration Coordinator
Telephone: 610-878-4000
Email: clinicaltrials@cslbehring.com
Study Officials: Study Director
Study Director
CSL Behring
Locations:
Open or close this module 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:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services