Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple Sclerosis

NCT02744222 | Completed Phase 2

• 1 other identifier: BCD-054-2
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 1

Brief Summary

An International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 μg and 240 μg, versus Avonex® (Biogen Idec Ltd., UK) in Patients with Relapsing-remitting Multiple Sclerosis

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• Time to first relapse after 52 weeks of blinded treatment with BCD-054 or Avonex

  Time to first relapse after 52 weeks of blinded treatment with BCD-054 or Avonex

  Week 52

Secondary Outcomes (23)

• CUA

  Week 20, Week 52, Week 104

• Proportion of patients without contrast-enhancing lesions

  Week 20, Week 52, Week 104

• Number of new or enlarging T2-weighted lesions

  Week 20, Week 52, Week 104

• Proportion of patients without new or enlarging T2-weighted lesions

  Week 20, Week 52, Week 104

• Changes in T2-weighted lesion volume

  Week 20, Week 52, Week 104

Study Arms (4)

BCD-054, 180 mcg, biweekly

EXPERIMENTAL

Patients of Groups 1 will receive blinded BCD-054 180 mcg intramuscularly once every two weeks for the first 52 weeks (including a 4-week titration phase from Week 0 to Week 3 inclusive). Between every two injections of the active drug, once every 2 weeks, patients will receive intramuscular injections of placebo.From Week 53 until Week 100, patients of Groups 1 will receive open-label BCD-054 180 mcg or 240 mcg intramuscularly once every 2 weeks

Biological: BCD-054 180 mcg

BCD-054, 240 mcg, biweekly

EXPERIMENTAL

Patients of Groups 2 will receive blinded BCD-054 240 mcg intramuscularly once every two weeks for the first 52 weeks (including a 4-week titration phase from Week 0 to Week 3 inclusive). Between every two injections of the active drug, once every 2 weeks, patients will receive intramuscular injections of placebo.From Week 53 until Week 100, patients of Groups 2 will receive open-label BCD-054 180 mcg or 240 mcg intramuscularly once every 2 weeks

Biological: BCD-054 240 mcg

Avonex®, 30 mcg, weekly

ACTIVE COMPARATOR

Patients of Group 3 (reference group) will receive blinded Avonex® 30 mcgintramuscularly once a week for the first 52 weeks (including a 4-week titration phase from Week 0 to Week 3 inclusive).

Biological: Avonex®

Placebo, 0,5 ml, weekly

PLACEBO COMPARATOR

Patients of Group 4 (placebo) will receive blinded placebo once a week for the first 20 weeks (including a 4-week titration phase from Week 0 to Week 3 inclusive)

Other: Placebo

Interventions

BCD-054 180 mcg BIOLOGICAL

180 mcg intramuscularly once every two weeks

Also known as: pegylated interferon beta-1a

BCD-054, 180 mcg, biweekly

Avonex® BIOLOGICAL

30 mcg intramuscularly once a week

Also known as: interferon beta-1a

Avonex®, 30 mcg, weekly

BCD-054 240 mcg BIOLOGICAL

240 mcg intramuscularly once every two weeks

Also known as: pegylated interferon beta-1a

BCD-054, 240 mcg, biweekly

Placebo OTHER

intramuscularly once a week (0,5 ml)

Placebo, 0,5 ml, weekly

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent to participate in the study;
• Men and women aged from 18 to 60 years (inclusive) on the day of signing informed consent;
• Confirmed diagnosis of relapsing-remitting multiple sclerosis (according to McDonald criteria 2010) ;
• Documentary evidence that within the last 12 months before signing informed consent the patient had:
• At least 1 relapse, or
• At least 1 Gadolinium enhancing T1-weighted lesion or 1 new T2-weighted lesion in dynamics.
• The patient should be neurologically stable during 30 days before signing informed consent (i.e. the patient should not have any new or aggravated neurological symptoms, as told by the patient); or the patient's condition should be completely stabilized since the last relapse, and the duration of stabilization should be at least 30 days) ;
• Patients of childbearing potential and their partners with preserved reproductive function must implement reliable contraceptive methods starting from signing informed consent to 4 weeks after the last dose of study therapy. This requirement does not apply to patients after operative sterilization. Reliable contraception methods include one barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives;
• Total EDSS score of 0 to 5.5 inclusive (assessed by the Assessing Neurologist).

You may not qualify if:

• Primary or secondary progressive MS;
• Other conditions (except for multiple sclerosis) that can affect the assessment of MS symptoms: to mask, aggravate, change symptoms of multiple sclerosis, result in clinical signs or laboratory instrumental findings suggesting multiple sclerosis;
• A relapse during the screening period ;
• Any acute infections, relapses of chronic infections or any other chronic diseases that are present on the day of signing informed consent and can, as judged by the Investigator, negatively affect the patient's safety during the study treatment;
• HIV, hepatitis B, hepatitis C, or syphilis ;
• Metabolic abnormalities (disorders) manifesting as:
• baseline creatinine levels increased more than 2-fold vs. upper limit of normal;
• baseline urea levels increased more than 3-fold vs. upper limit of normal;
• baseline ALT, AST or GGT levels increased more than 2.5-fold vs. upper limit of normal;
• baseline bilirubin levels increased more than 1.5-fold vs. upper limit of normal;
• Baseline leukocyte counts lower than \<3.0 × 109/L, platelet counts lower than \<125 × 109/L or hemoglobin levels \<100 g/L;
• A history of severe depression, suicidal thoughts or suicide attempts ;
• Signs of clinically significant depression (baseline Beck's score of more than 15);
• A history of hypothyroidism/hyperthyroidism and/or baseline abnormalities of TSH levels vs. lower or upper limits of normal;
• Epilepsy;

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

State Budgetary Healthcare Institution of Nizhny Novgorod region " "Regional Clinical Hospital N.A. Semashko, Nizhny Novgorod"

Nizhny Novgorod, Russia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

sampeginterferon beta-1a; Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Roman Ivanov, PhD

  JCS BIOCAD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 20, 2016
• Study Start: August 10, 2017
• Primary Completion: November 23, 2018
• Study Completion: July 6, 2020
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)