Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
NCT ID: NCT02586805
Last Updated: 2021-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
125 participants
INTERVENTIONAL
2016-03-03
2017-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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DX-2930 300 mg every 2 weeks
300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
DX-2930 - 300mg/2wk
300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
DX-2930 300 mg every 4 weeks
300 mg DX-2930 administered every 4 weeks by subcutaneous injection
DX-2930 - 300mg/4wk
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.
DX-2930 150 mg every 4 weeks
150 mg DX-2930 administered every 4 weeks by subcutaneous injection
DX-2930 - 150mg/4wk
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.
Placebo
Placebo administered every 2 weeks by subcutaneous injection.
Placebo
Placebo administered every 2 weeks by subcutaneous injection.
Interventions
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DX-2930 - 300mg/2wk
300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
DX-2930 - 300mg/4wk
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.
DX-2930 - 150mg/4wk
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.
Placebo
Placebo administered every 2 weeks by subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of HAE, Type I or II
* Baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks
* Adult subjects and caregivers of subjects under the age of 18 are willing and able to read, understand, and sign an informed consent form. Subjects age 12 to 17, whose caregiver provides informed consent, are willing and able to read, understand an dsign an assent form.
* Males and femailes who are fertile and sexually active must adhere to contraception requirements.
Exclusion Criteria
* Participation in a prior DX-2930 study
* Treatment with any other investigational drug or exposure to an investigational device within 4 weeks prior screening
* Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications within 4 weeks prior to screening.
* Exposure to androgens within 2 weeks prior to entering the run-in period.
* Use of long-term prophylactic therapy for HAE within 2 weeks prior to entering the run-in period.
* Use of short-term prophylaxis for HAE within 7 days prior to entering the run-in period.
* Any of the following liver function test abnormalities: alanine aminotransferase (ALT) \> 3x upper limit of normal, or aspartate aminotransferase (AST) \> 3x upper limit of normal, or total bilirubin \> 2x upper limit of normal (unless the bilirubin elevation is a result of Gilbert's syndrome).
* Pregnancy or breastfeeding.
12 Years
ALL
No
Sponsors
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Dyax Corp.
INDUSTRY
Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Shire Physician
Role: STUDY_DIRECTOR
Shire
Locations
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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
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Hospital and Health System
Ann Arbor, Michigan, United States
Midwest Immunology Clinic
Plymouth, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hudson-Essex Allergy, LLC
Belleville, New Jersey, United States
Atlantic Research Center, LLC
Ocean City, New Jersey, United States
Winthrop University Hospital
Mineola, New York, United States
The Mount Sinai Medical Center
New York, New York, United States
American Health Research
Charlotte, North Carolina, United States
Duke Asthma, Allergy and Airway Center
Durham, North Carolina, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Optimed Research, LTD
Columbus, Ohio, United States
Toledo Institute of Clinical Research
Toledo, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Austin Regional Clinic
Austin, Texas, United States
AARA Research Center
Dallas, Texas, United States
Intermountain Clinical Research
Draper, Utah, United States
Allergy Associates of Utah
Murray, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Marycliff Allergy Specialists
Spokane, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, Canada
Clinique Specialisee en Allergie de la Capitale
Québec, Quebec, Canada
Charité - University of Berlin
Berlin, , Germany
Hautklinik und Poliklinik der Universitätsmedizin
Mainz, , Germany
HZRM Hamophilie-Zentrum Rhein Main
Mörfelden-Walldorf, , Germany
Hospital L. Sacco, Milan University
Milan, , Italy
Triumpharma
Amman, , Jordan
Sociedad Alergologica
San Juan, PR, Puerto Rico
Barts Health NHS Trust Clinical Research Centre
London, , United Kingdom
Countries
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References
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Lumry WR, Maurer M, Weller K, Riedl MA, Watt M, Yu M, Devercelli G, Meunier J, Banerji A; HELP OLE Study Group. Long-term lanadelumab treatment improves health-related quality of life in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2023 Jul;131(1):101-108.e3. doi: 10.1016/j.anai.2023.03.028. Epub 2023 Apr 5.
Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
Craig TJ, Zaragoza-Urdaz RH, Li HH, Yu M, Ren H, Juethner S, Anderson J; HELP and HELP OLE Study Investigators. Effectiveness and safety of lanadelumab in ethnic and racial minority subgroups of patients with hereditary angioedema: results from phase 3 studies. Allergy Asthma Clin Immunol. 2022 Sep 24;18(1):85. doi: 10.1186/s13223-022-00721-y.
Banerji A, Riedl MA, Bernstein JA, Cicardi M, Longhurst HJ, Zuraw BL, Busse PJ, Anderson J, Magerl M, Martinez-Saguer I, Davis-Lorton M, Zanichelli A, Li HH, Craig T, Jacobs J, Johnston DT, Shapiro R, Yang WH, Lumry WR, Manning ME, Schwartz LB, Shennak M, Soteres D, Zaragoza-Urdaz RH, Gierer S, Smith AM, Tachdjian R, Wedner HJ, Hebert J, Rehman SM, Staubach P, Schranz J, Baptista J, Nothaft W, Maurer M; HELP Investigators. Effect of Lanadelumab Compared With Placebo on Prevention of Hereditary Angioedema Attacks: A Randomized Clinical Trial. JAMA. 2018 Nov 27;320(20):2108-2121. doi: 10.1001/jama.2018.16773.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Statistical Analysis Plan: Original
Document Type: Statistical Analysis Plan: Amendment 1
Other Identifiers
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2015-003943-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DX-2930-03
Identifier Type: -
Identifier Source: org_study_id
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