Clinical Trials

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: atypical hemolytic uremic syndrome (aHUS)

Therapeutic area: Rare diseases - Kidney diseases - Renal diseases

Country:

Trial details:

The aHUS trial is a Phase 3, open-label, single arm, multicenter 26-week study to evaluate the safety and efficacy of ALXN1210 in complement inhibitor treatment-naïve adolescent and adult patients with atypical hemolytic uremic syndrome. The primary endpoint is complete thrombotic microangiopathy (TMA) response at 26 weeks. Secondary endpoints include dialysis requirement status, complete TMA response over time, observed value and change from baseline in estimated glomerular filtration rate, and change from baseline in chronic kidney disease stage, all evaluated at 26 weeks; time to complete TMA response; and additional efficacy measures. Patients will receive a single loading dose of ALXN1210, followed by regular maintenance dosing every 8 weeks based on 3 weight cohorts. (NCT02949128)

Latest news:

• On October 27, 2016, Alexion Pharmaceuticals announced the initiation of a registration trial of ALXN1210 in patients with atypical hemolytic uremic syndrome (aHUS). This Phase 3, open-label, single arm, multinational trial will evaluate the safety and efficacy of ALXN1210 in complement inhibitor treatment-naïve adolescent and adult patients with aHUS. The study will evaluate ALXN1210 administered intravenously every eight weeks. Alexion expects to begin enrolling patients into this trial later this year.
The multinational study will enroll approximately 55 adolescent (12 to < 18 years of age) and adult (? 18 years of age) patients with aHUS who have never been treated with a complement inhibitor.