International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis

PHASE3CompletedINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

February 9, 2018

Primary Completion Date

December 24, 2018

Study Completion Date

March 31, 2022

Conditions
Ankylosing Spondylitis
Interventions
DRUG

BCD-085

120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week

OTHER

placebo

2 ml of placebo subcutaneously at week 0,1 2 and every other week, starting from week 16 - 120 mg of BCD-085 subcutaneously at week 16,17 and 18 every other week

Trial Locations (7)

355047

"Non-governmental Healthcare Institution Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways", Chelyabinsk

Unknown

Chelyabinsk Regional Clinical hospital, Chelyabinsk

Kazan State Medical University, Kazan'

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University, Moscow

Omsk Regional Clinical Hospital, Omsk

LLC BioEk, Saint Petersburg

North-Western State Medical University n.a. I.I.Mechnikov, Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY

NCT03447704 - International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing Spondylitis | Biotech Hunter | Biotech Hunter