Status:
COMPLETED
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in...
Detailed Description
This is an open-label extension study of donidalorsen in up to 24 participants with HAE. The length of participation in the study is approximately 68 weeks, which includes an up to 4-week qualificatio...
Eligibility Criteria
Inclusion
- Satisfactory completion of ISIS 721744-CS2 (index study) through Week 17 with an acceptable safety and tolerability profile, per Sponsor and Investigator judgement
- Able and willing to participate in a 64-week study
- Females must be non-pregnant, non-lactating and either surgically sterile or post-menopausal
- Males must be surgically sterile or abstinent\* or if engaged in sexual relations with a female of child-bearing potential, participant is utilizing an acceptable contraceptive method
- Participants must have access to, and the ability to use, ≥ 1 acute medication(s) (e.g., plasma-derived or recombinant C1- inhibitor (C1-INH) concentrate or a bradykinin-2 \[BK-2\] antagonist) to treat angioedema attacks
Exclusion
- 1\. Have any new condition or worsening of an existing condition or change or anticipated change in medication, which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04307381
Start Date
April 1 2020
End Date
January 24 2025
Last Update
March 24 2025
Active Locations (7)
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1
Ionis Investigative Site
Scottsdale, Arizona, United States, 85251
2
Ionis Investigative Site
Santa Monica, California, United States, 90404
3
Ionis Investigative Site
Plymouth, Minnesota, United States, 55446
4
Ionis Investigative Site
Cincinnati, Ohio, United States, 45231