This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
125
300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Time frame: From Day 0 to Day 182
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
Time frame: From Day 0 to Day 182
Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Moderate and severe investigator-confirmed HAE attacks were the attacks that were moderate or severe as per the HAE attack assessment and reporting procedures (HAARP) defined severity. The overall severity of attack was determined by the investigator using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Rate of moderate or severe investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.
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Placebo administered every 2 weeks by subcutaneous injection.
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
Medical Research of Arizona
Scottsdale, Arizona, United States
UC San Diego School of Medicine
San Diego, California, United States
AIRE Medical of Los Angeles
Santa Monica, California, United States
Allergy & Asthma Clinical Research
Walnut Creek, California, United States
IMMUNOe International Health & Research Centers
Centennial, Colorado, United States
Asthma and Allergy Associates, P.C.
Colorado Springs, Colorado, United States
University of South Florida
Tampa, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Institute of Asthma & Allergy, P.C.
Chevy Chase, Maryland, United States
...and 31 more locations
Time frame: From Day 0 to Day 182
Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through Day 182
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks during day 14 after study drug administration through day 182 was analyzed by the same poisson regression model as in the primary endpoint analysis.
Time frame: From Day 14 to Day 182