A Phase 2 in Adult Subjects With Hereditary Angioedema (NCT06846398) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2 in Adult Subjects With Hereditary Angioedema
United States25 participantsStarted 2025-02-28
Plain-language summary
A Phase 2 in Adult Subjects with Hereditary Angioedema
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Must have given written informed consent and be able to comply with all study requirements.
* Males or females 18 to 70 years of age at the time of informed consent.
* Documented diagnosis of HAE-1/HAE-2.
* At least 2 HAE attacks within the 8-week run-in period, as confirmed by an investigator based on the protocol-specified definition
* Access to and ability to use ≥ 1 acute medication(s)
* Female subjects must be non-pregnant;non-lactating, and either surgically sterile
* Male subjects with WOCBP partners, dual contraception is required if no surgically sterile
Exclusion Criteria:
* Any clinically significant medical or psychiatric condition or medical history that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
* Any concomitant diagnosis of another form of chronic angioedema, such as acquired angioedema, HAE with normal C1-INH, idiopathic angioedema, or recurrent angioedema associated with urticaria
* History or presence of carcinoma within 5 years prior to screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
* Have undergone major surgery within 3 months prior to screening.
* History of clinically significant arterial or venous thrombosis, or current clinically significant prothrombotic or bleeding risk
* History of allergic reaction to an oligonucleotide or N-acetylgalactosamine
* Prior treatment with any oligonuc…
What they're measuring
1
To determine the prophylactic effect of in HAE attack rate.