Safety evaluation of switching to garadacimab for hereditary angioedema patients aged 12 and older
A Phase 4 Open-label Study to Evaluate the Safety After Switching to CSL312 (Garadacimab) From Current Prophylactic HAE Treatment in Subjects With HAE ≥ 12 Years of Age
PHASE4 · CSL Behring · NCT06806657
This study is testing whether switching patients aged 12 and older with hereditary angioedema to a new treatment called garadacimab is safe and effective for managing their symptoms.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | CSL Behring (industry) |
| Drugs / interventions | lanadelumab, garadacimab |
| Locations | 11 sites (Litchfield Park, Arizona and 10 other locations) |
| Trial ID | NCT06806657 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of switching patients aged 12 years and older with hereditary angioedema (HAE) to garadacimab from their current prophylactic treatment, which may include kallikrein inhibitors or plasma-derived C1-esterase inhibitors. Participants will receive garadacimab once monthly for approximately three months. The study aims to ensure that this transition does not adversely affect the patients' health and continues to provide effective management of HAE symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 years and older with a documented diagnosis of hereditary angioedema and a history of response to on-demand treatment for acute attacks.
Not a fit: Patients who do not have hereditary angioedema or those who have not responded to previous treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with hereditary angioedema.
How similar studies have performed: Other studies have shown success with similar monoclonal antibody approaches for treating hereditary angioedema, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Aged \>= 12 years at the time of providing written informed consent / assent. * • Have a history of response to on-demand HAE treatment for the treatment of acute HAE attacks. * • Documented laboratory diagnosis in medical records of C1-esterase inhibitor hereditary angioedema (HAE-C1INH) type 1 or type 2: * ◦ Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria), * ◦ C1-esterase inhibitor (C1INH) antigen concentration or functional activity less than (\<) 50% of normal as documented in the participant's medical record, or * ◦ C4-antigen concentration below the lower limit of the reference range as documented in the participant's medical record. * For HAE-nC1INH: Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria); an HAE-associated FXII gene mutation (eg, FXII point mutation Thr328Lys or Thr328Arg, or deletion of 72 base pairs \[c.971\_1018 + 24del72\], or duplication of 18 base pairs \[c.892-909dup\]), as documented in the participant's medical record, OR an HAE-associated plasminogen gene mutation (PLG) gene mutation (eg, PLG point mutation Lys330Glu), as documented in the participant's medical record; C1INH antigen concentration or functional activity 70 to 120% of the normal level, as documented in the participant's medical record. * • Use of lanadelumab, berotralstat, or pdC1INH for the prophylactic treatment of HAE and be on a stable (consistent) dose / regimen of such medication for at least 3 months prior to Screening. Exclusion Criteria: * • Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema or recurrent angioedema associated with urticaria. * • Use of androgens, antifibrinolytics, or investigational products (other than garadacimab) for routine prophylaxis against HAE attacks. * • Known or suspected hypersensitivity to monoclonal antibody therapy or hypersensitivity to the active substance (garadacimab) or to any of the excipients.
Where this trial is running
Litchfield Park, Arizona and 10 other locations
- Research Solutions of Arizona — Litchfield Park, Arizona, United States (RECRUITING)
- Allergy and Asthma Clinic of Northwest Arkansas — Bentonville, Arkansas, United States (RECRUITING)
- Donald Levy M.D. — Orange, California, United States (RECRUITING)
- Raffi Tachdjian MD, Inc. — Santa Monica, California, United States (RECRUITING)
- Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States (RECRUITING)
- Chronicle Bio — West Valley City, Utah, United States (RECRUITING)
- McMaster University-Hamilton — Hamilton, Ontario, Canada (RECRUITING)
- Montreal Clinical Research Institute — Montreal, Quebec, Canada (RECRUITING)
- Clinique Spécialisée en Allergie de la Capitale — Québec, Canada (RECRUITING)
- HZRM Hämophilie Zentrum Rhein Main GmbH — Frankfurt, Germany (RECRUITING)
- Hautklinik und Poliklinik der Universitätsklinik Mainz — Mainz, Germany (RECRUITING)
Study contacts
- Study coordinator: Trial Registration Coordinator
- Email: clinicaltrials@cslbehring.com
- Phone: +1 610-878-4697
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hereditary Angioedema, Autosomal dominant disease, Hereditary angioedema attack, Monoclonal antibody