Date: 2016-10-27
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Alexion Pharmaceuticals (USA - CT)
Product: ALXN1210 (ravulizumab - Fc- and CDR-modified humanised monoclonal antibody against C5)
Action
mechanism: monoclonal antibody. Ravulizumab is an anti-C5 monoclonal antibody. This longer-acting anti-C5 antibody inhibits terminal complement.
Disease: paroxysmal nocturnal hemoglobinuria (PNH)
Therapeutic
area: Rare diseases - Immunological diseases
Country: Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Estonia, France, Germany ,Italy, Japan, Republic of Korea, Malaysia, Mexico, Poland, Russian Federation, Singapore, Spain, Sweden, Taiwan, Thailand, Turkey ,UK, USA
Trial
details:
- The PNH trial is a Phase 3, randomized, open-label, active-controlled, multicenter 26-week study to evaluate the safety and efficacy of ALXN1210 compared to eculizumab in complement inhibitor treatment-naïve patients with paroxysmal nocturnal hemoglobinuria.
- The co-primary endpoints are the normalization of lactate dehydrogenase (LDH) levels and the percentage of patients who achieve transfusion avoidance (TA).
- Secondary endpoints include percentage change from baseline in LDH levels, change from baseline in quality of life as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and percentage of patients with stabilized hemoglobin.
- The study is designed to evaluate the non-inferiority of ALXN1210 compared to eculizumab. Patients in the ALXN1210 arm will receive a single loading dose of ALXN1210, followed by regular maintenance dosing every 8 weeks based on 3 weight cohorts. Patients in the eculizumab arm will receive 4 weekly induction doses, followed by regular maintenance dosing every 2 weeks. The multinational study will enroll approximately 214 adults (? 18 years of age) with a diagnosis of PNH who have never been treated with a complement inhibitor. (NCT02946463)
Latest
news:
- • On October 27, 2016, Alexion Pharmaceuticals, announced the initiation of a Phase 3 open-label, multinational, active-controlled study of ALXN1210 compared to eculizumab (Soliris®) in complement inhibitor treatment-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH). The study will evaluate ALXN1210 administered intravenously every eight weeks. Alexion expects to begin enrolling patients later this year.
Is
general: Yes
