2024-11-06
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-09→2025-01
Completion date2025-04→2026-09
Study arms2→1
InterventionsPlacebo (Drug), divozilimab (Biological)→divozilimab (Biological)
Secondary endpoints9 to 10 entries
Time to the first adjudicated relapse
Primary endpoints1 entry, revised
TimeAdjudicated to the first adjudicatedannualized relapse withinrate the first[Week 24 weeks of the studу]
Study description-487 characters
BCD-132-6/AQUARELLE is aan randomized, doubleopen-blind, placebo-controlledlabel phase 3 clinical study in subjects with NMOSD.
Eligible subjects will be randomized at a 2:1 ratio to the divozilimab and placebo groups, respectively.
At randomization, subjects will be stratified according to the presence of anti-AQP4 antibodies and number of relapses during the past 12 months.
Approximately 105 subjects will be enrolled.
The study consists of a screening period, a treatment period (Stage 1 and Stage 2), and a follow-up period.The maximum duration of Stage 1 will be about 24 weeks.
During Staget [...] [...]
Study sitesdetails revised at 19 of 19 sites
2023-02-17
minor
Study Status, Arms and Interventions, Outcome Measures v1
Interventionsdivozilimab (Biological)→Placebo (Drug), divozilimab (Biological)
Secondary endpoints10 to 9 entries
Change in the Expanded Disability Status Scale (EDSS) score
Changes in the severity of pain using a numericNumeric ratingRating scale
Proportion of subjects with neuropathic pain using DN4Scale