Multiple Sclerosis, Relapsing-RemittingPhase 2/3NCT02744222

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

A Phase 2/3 study testing BCD-054 180 mcg, Avonex® and BCD-054 240 mcg in people with Multiple Sclerosis, Relapsing-Remitting, run by Biocad at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Multiple Sclerosis, Relapsing-Remitting
What is being tested?: BCD-054 180 mcg, Avonex® and BCD-054 240 mcg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 399 participants
Where: 1 siteRussia
Study dates: 10 Aug 2017to 6 Jul 2020
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Show all 9Show fewer

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).

Who cannot join

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:

Show all 31Show fewer

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;
Pregnancy, lactation or planned pregnancy over the entire study period;
A history of use:
any time before signing informed consent: disease-modifying interferon beta drugs (interferon beta-1a, interferon beta-1b),
within 30 days before signing informed consent: glatiramer acetate;
within 6 months before signing informed consent: monoclonal antibodies, cytotoxic and/or immunosuppressive drugs, including but not limited to mitoxantrone, cyclophosphamide, cyclosporine, fingolimod, cladribine; or total lymphoid irradiation;
Systemic (i.v. or oral) corticosteroids used within 30 days before signing informed consent;
A history of intolerance of or allergy to pegylated proteins, interferon beta or other ingredients of BCD-054/Avonex®;
Known alcoholic or drug dependency or signs of present alcoholic/drug dependence that, in the Investigator's opinion, can be contraindications for study therapy of multiple sclerosis with interferon beta-1a or limit treatment compliance;
Inability to follow the Protocol procedures (in the Investigator's opinion).
Contraindications to MRI or use of gadolinium-containing contrast agents:
Metal foreign objects in the body: magnetic implants, ferromagnetic clips for cerebral vessels, artificial heart valves, electronic middle ear implants, pacemakers;
A history of allergy to gadolinium or gadolinium-containing contrast agents;
с) Fear of cramped spaces; d) Kidney function impairment with a risk of delayed gadolinium elimination (creatinine level increased to more than 2 x upper limit of normal); e) Documented diagnosis of sickle cell or hemolytic anemia, hemoglobinopathy.
Any malignancies or a history of malignancies, except for cured basal cell carcinoma or cervical cancer in situ;
Vaccination within 4 weeks before signing informed consent (as told by the patient);
Participation in other clinical studies within 90 months before signing informed consent.

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

Other trials in Russia

About this study

Official title: 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
Being tested: BCD-054 180 mcg, Avonex®, BCD-054 240 mcg, Placebo
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BCD-054 180 mcgBiological
Also called pegylated interferon beta-1a
180 mcg intramuscularly once every two weeks
Avonex®Biological
Also called interferon beta-1a
30 mcg intramuscularly once a week
BCD-054 240 mcgBiological
Also called pegylated interferon beta-1a
240 mcg intramuscularly once every two weeks
PlaceboOther
intramuscularly once a week (0,5 ml)

Study groups in NCT02744222
Study group	Role	What they receive
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 Receives: 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 Receives: 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). Receives: 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) Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Week 52

Secondary outcomes (23)

CUA
Measured: Week 20, Week 52, Week 104
Proportion of patients without contrast-enhancing lesions
Measured: Week 20, Week 52, Week 104
Number of new or enlarging T2-weighted lesions
Measured: Week 20, Week 52, Week 104
Proportion of patients without new or enlarging T2-weighted lesions
Measured: Week 20, Week 52, Week 104
Changes in T2-weighted lesion volume
Measured: Week 20, Week 52, Week 104
Changes in hypointense T1-weighted lesion volume
Measured: Week 20, Week 52, Week 104
Annual average frequency of relapses
Measured: Week 20, Week 52, Week 104
Proportion of relapse-free patients
Measured: Week 20, Week 52, Week 104
Proportion of patients with sustained disability progression
Measured: Week 20, Week 52, Week 104
Expanded Disability Status Scale (EDSS)
Measured: Week 20, Week 52, Week 104
Timed 25-Foot Walk
Measured: Week 20, Week 52, Week 104
9-Hole Peg Test (9 HPT)
Measured: Week 20, Week 52, Week 104
Symbol Digit Modalities Test (SDMT)
Measured: Week 20, Week 52, Week 104
The proportion of patients who developed AEs/SAEs that, in the Investigator's opinion, are related to BCD-054 or Avonex®
Measured: Week12, Week 20, Week 52, Week 104
The proportion of patients, in each group, who developed СТСАЕ v. 4.03 Grade 3-4 AEs that, in the Investigator's opinion, are related to BCD-054 or Avonex®
Measured: Week12, Week 20, Week 52, Week 104
The proportion of patients, in each group, who discontinued the study due to AEs/SAEs
Measured: Week12, Week 20, Week 52, Week 104
The proportion of BAb- and NAb-positive patients
Measured: Week 20, Week 52, Week 104
AUC (0-168 hours)
Area under the IFN-β1а concentration vs. time curve to 168 h (AUC(0-168)) with the first full dose of BCD-054 or Avonex® (Week 4)
Measured: from 0 to 168 hours after the first full dose of BCD-054 or Avonex® (Week 4)
AUC (0-336 hours)
Area under the IFN-β1а concentration vs. time curve to 336 h (AUC(0-336)) with the first full dose of BCD-054 or Avonex® (Week 4)
Measured: from 0 to 336 hours after the first full dose of BCD-054 or Avonex® (Week 4)
AUCss (0-168 hours, 0-336 hours)
AUCss (0-168 hours, 0-336 hours) - area under curve "concentration - time" from 0 to 168 hours and from 0 to 336 hours(since the introduction of 17 injections, in steady state conditions)
Measured: from 0 to 168 hours and from 0 to 336 hours since the introduction of 17 injections
AUECss (0-168 hours, 0-336 hours)
AUECss (0-168 hours, 0-336 hours) - area under effect curve "concentration of MxA-protein/neopterin - time" from 0 to 168 hours and from 0 to 336 hours (since the introduction of 17 injections, in steady state conditions)
Measured: from 0 to 168 hours and from 0 to 336 hours after isince the introduction of 17 injections
AUEC (0-168 hours)
Area under the effect (concentration of MxA protein/neopterin) vs. time curve to 168 h (AUC(0-168)) with the first full dose of BCD-054 or Avonex® (Week 4
Measured: from 0 to 168 hours after the first full dose of BCD-054 or Avonex® (Week 4)
AUEC (0-336 hours)
Area under the effect (concentration of MxA protein/neopterin) vs. time curve to 336 h (AUEC(0-336)) with the first full dose of BCD-054 or Avonex® (Week 4)
Measured: from 0 to 336 hours after the first full dose of BCD-054 or Avonex® (Week 4)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 20176 Jul 2020

First posted20 Apr 2016 (estimated)
Study start10 Aug 2017
Primary completion23 Nov 2018
Study completion6 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
More trials run by BiocadThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 399 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02744222
Sponsor's protocol ID: BCD-054-2
Status last verified: Sep 2021
First submitted: 3 Apr 2016
Last updated: 8 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis

All Multiple Sclerosis, Relapsing-Remitting trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02744222
Acronym / sponsor ID: BCD-054-2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 399 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: 10 Aug 2017 (actual)
Primary completion: 23 Nov 2018 (actual)
Study completion: 6 Jul 2020 (actual)
First posted: 20 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
BCD-054, 180 mcg, biweekly	Experimental	Biological: BCD-054 180 mcgPatients 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
BCD-054, 240 mcg, biweekly	Experimental	Biological: BCD-054 240 mcgPatients 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
Avonex®, 30 mcg, weekly	Active comparator	Biological: Avonex®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).
Placebo, 0,5 ml, weekly	Placebo comparator	Other: PlaceboPatients 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)

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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:
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) ;

Key exclusion criteria (31 listed)

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 ;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BCD-054 180 mcgAlso: pegylated interferon beta-1a180 mcg intramuscularly once every two weeks	Biological	BCD-054, 180 mcg, biweekly
Avonex®Also: interferon beta-1a30 mcg intramuscularly once a week	Biological	Avonex®, 30 mcg, weekly
BCD-054 240 mcgAlso: pegylated interferon beta-1a240 mcg intramuscularly once every two weeks	Biological	BCD-054, 240 mcg, biweekly
Placebointramuscularly once a week (0,5 ml)	Other	Placebo, 0,5 ml, weekly

Primary outcome

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

23 secondary outcomes

CUA
Time frame: Week 20, Week 52, Week 104
Proportion of patients without contrast-enhancing lesions
Time frame: Week 20, Week 52, Week 104
Number of new or enlarging T2-weighted lesions
Time frame: Week 20, Week 52, Week 104
Proportion of patients without new or enlarging T2-weighted lesions
Time frame: Week 20, Week 52, Week 104
Changes in T2-weighted lesion volume
Time frame: Week 20, Week 52, Week 104
Changes in hypointense T1-weighted lesion volume
Time frame: Week 20, Week 52, Week 104
Annual average frequency of relapses
Time frame: Week 20, Week 52, Week 104
Proportion of relapse-free patients
Time frame: Week 20, Week 52, Week 104
Proportion of patients with sustained disability progression
Time frame: Week 20, Week 52, Week 104
Expanded Disability Status Scale (EDSS)
Time frame: Week 20, Week 52, Week 104
Timed 25-Foot Walk
Time frame: Week 20, Week 52, Week 104
9-Hole Peg Test (9 HPT)
Time frame: Week 20, Week 52, Week 104
Symbol Digit Modalities Test (SDMT)
Time frame: Week 20, Week 52, Week 104
The proportion of patients who developed AEs/SAEs that, in the Investigator's opinion, are related to BCD-054 or Avonex®
Time frame: Week12, Week 20, Week 52, Week 104
The proportion of patients, in each group, who developed СТСАЕ v. 4.03 Grade 3-4 AEs that, in the Investigator's opinion, are related to BCD-054 or Avonex®
Time frame: Week12, Week 20, Week 52, Week 104
The proportion of patients, in each group, who discontinued the study due to AEs/SAEs
Time frame: Week12, Week 20, Week 52, Week 104
The proportion of BAb- and NAb-positive patients
Time frame: Week 20, Week 52, Week 104
AUC (0-168 hours)
Time frame: from 0 to 168 hours after the first full dose of BCD-054 or Avonex® (Week 4)
AUC (0-336 hours)
Time frame: from 0 to 336 hours after the first full dose of BCD-054 or Avonex® (Week 4)
AUCss (0-168 hours, 0-336 hours)
Time frame: from 0 to 168 hours and from 0 to 336 hours since the introduction of 17 injections
AUECss (0-168 hours, 0-336 hours)
Time frame: from 0 to 168 hours and from 0 to 336 hours after isince the introduction of 17 injections
AUEC (0-168 hours)
Time frame: from 0 to 168 hours after the first full dose of BCD-054 or Avonex® (Week 4)
AUEC (0-336 hours)
Time frame: from 0 to 336 hours after the first full dose of BCD-054 or Avonex® (Week 4)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
Individual participant dataSharing planned: No

Related trials for Multiple Sclerosis, Relapsing-Remitting

Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Roman Ivanov, PhD study chair

JCS BIOCAD

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BCD-054 180 mcg, Avonex® and BCD-054 240 mcg in people with Multiple Sclerosis, Relapsing-Remitting, run by Biocad at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first relapse after 52 weeks of blinded treatment with BCD-054 or Avonex (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02744222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.