NL-OMON49723CompletedPhase 2
A Randomized, Double Blind, Placebo Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second Generation Ligand Conjugated Antisense Inhibitor of Prekallikrein, in Patients with Hereditary Angioedema - ISIS 721744-CS2
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ionis Pharmaceuticals, Inc.
- Enrollment
- 8
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Documented diagnosis of HAE-1/HAE-2 (for inclusion in Part A) or HAE-nC1-INH
- •(for inclusion in Part B);
- •- Participants must experience a minimum of 2 HAE attacks (assessed by the
- •Angioedema Activity Score [AAS] and confirmed by the investigator) during the
- •screening period;
- •- Access to, and the ability to use, 1 or more acute medication(s) to treat
- •angioedema attacks.
Exclusion Criteria
- •- Anticipated use of short-term prophylaxis for angioedema attacks for a
- •pre-planned procedure during the Screening or Study Periods.
- •- Concurrent diagnosis of any other type of recurrent angioedema, including
- •acquired or idiopathic angioedema.
- •- History of acquired coagulopathies or bleeding diathesis.
- •- Active infection with human immunodeficiency virus (HIV), hepatitis C or
- •chronic hepatitis B.
- •- Malignancy within 5 years, except for basal or squamous cell carcinoma of the
- •skin or carcinoma in situ of the cervix that has been successfully treated.
- •- Treatment with another investigational drug or biological agent within 1
- •month or 5 half-lives, whichever is longer, of Screening.
- •- Exposure to any of the following medications:
- •a. Angiotensin-converting enzyme (ACE) inhibitors or any estrogen containing
- •medications with systemic absorption (such as oral contraceptive or hormonal
- •replacement therapy) within 4 weeks prior to Screening.
- •b. Chronic prophylaxis with Lanadelumab within 10 weeks prior to Screening.
- •c. Oligonucleotides (including small interfering RNA) within 4 months of
- •Screening if single dose received, or within 12 months of Screening if multiple
- •doses received.
Investigators
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