Clinical study BCD-132–6/AQUARELLE «An Open-label Study of the Efficacy and Safety of Divozilimab in Patients with Neuromyelitis Optica Spectrum Disorders»
The BCD-132/AQUARELLE clinical study will evaluate the efficacy of divozilimab versus placebo (historical control) in subjects with neuromyelitis optica spectrum disorders (NMOSD) in terms of the adjudicated annualized relapse rate at month 6[1] after enrollment of the last subject in the study in patients who:
Have a diagnosis of neuromyelitis optica according to the 2015 diagnostic criteria of the International Panel on NMO Diagnosis (IPND).
Are aged 18 years or older.
Had a documented relapse within the last 12 months or 2 documented relapses within the last 24 months.
Have a total EDSS ( Expanded Disability Status Scale) score ≤7.
Have IgG antibodies to varicella zoster virus (human herpesvirus 3) based on the results of a screening examination.
Agree to use reliable contraception during and for 6 months after their participation in the clinical study, and to refuse to donate eggs or sperm.
This study has exclusion criteria (precluding participation in this clinical study), which will all be explained to the potential participant by the study doctor. In particular, the exclusion criteria are:
Relapse less than 30 days before signing the informed consent form or during screening.
Other nervous system disorders (including multiple sclerosis) that may mask or affect the assessment of neuromyelitis optica symptoms.
A history of other autoimmune diseases that require immunosuppressive therapy.
A history of splenectomy.
A malignancy, or a history thereof, with the exception of cured basal cell carcinoma, cervical cancer in situ, and cured solid tumors with a remission of more than 5 years.
Heart failure (NYHA (New York heart Association) functional classes III-IV).
A diagnosis of HIV infection, hepatitis B or C, syphilis.
A history of tuberculosis or tuberculosis detected at screening.
Current or previous alcohol or drug addiction.
Contraindications to MRI and/or use of gadolinium-containing contrast agents.
Pregnancy, breastfeeding, or planned pregnancy at any time during the participation in the study and 6 months after the scheduled last administration of the study drug in this study.
The BCD-132-6/AQUARELLE study takes place in study centers of different cities in the Russian Federation and the Republic of Belarus: Tomsk, Kemerovo, Krasnodar, Moscow, Rostov-on-Don, Ulyanovsk, Saransk, Kirov, Novosibirsk, Chelyabinsk, Pyatigorsk, Nizhny Novgorod, Samara, Krasnoyarsk, Tyumen, Barnaul, Yaroslavl, Perm, Kazan, Minsk, and Vitebsk.
You can ask questions about participation in the clinical study and request contact information about study centers using a special form «Do you have any questions?».
The study doctor will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the study and consult the study doctor and/or attending physician.