Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple Sclerosis

A Phase 1 study testing BCD-132 in people with Multiple Sclerosis, run by Biocad at 5 sites in Russia.

Completed

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

Trial summary

BCD-132 is a humanized monoclonal antibody against CD20. BCD-132-1 is a Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) 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
What is being tested?: BCD-132
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 5 sitesRussia
Study dates: 22 Feb 2018to 28 Mar 2019
Phase: Phase 1
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 written 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 one relapse, or
At least one gadolinium enhancing T1-weighted lesion or one new T2-weighted lesion in dynamics.

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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 during this period, 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);
A total EDSS score of 0 to 5.5 inclusive (assessed by the Assessing Neurologist);
Presence of IgG antibodies to varicella zoster virus according to screening results;
Patients of childbearing potential and their partners with preserved reproductive function must implement reliable contraceptive methods starting from signing informed consent and throughout the study. 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.
Body weight ≥65 kg at the screening
The absence of suicidal ideation and suicidal behavior, as assessed by the C-SSRC scale, for the period of the 1st month preceding the signing of the informed consent by the patient (0 score in the evaluation of suicidal ideation and the lack of positive responses in the section of suicidal behavior) established in the screening.

Who cannot join

Primary and secondary progressive multiple sclerosis;
Multiple sclerosis duration of more than 10 years with EDSS score ≤2.0 according to screening results;
Other conditions (except for multiple sclerosis) that can affect the assessment of multiple sclerosis 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;

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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 × 10 9/L, platelet counts lower than <125 × 10 9/L or hemoglobin levels <100 g/L;
A history of severe depression, suicidal thoughts or suicide attempts;
Signs of clinical 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: anti-B-cell agents (e.g., rituximab, ocrelizumab, abatacept, belimumab, ofatumumab, etc.);
any time before signing informed consent: alemtuzumab, anti-CD4 agents, daclizumab, teriflunomide, laquinimod, mitoxantrone, cladribine, total lymphatic irradiation, bone marrow transplant;
within 2 years (24 months) before signing informed consent: cyclophosphamide, cyclosporin, azathioprine; mycophenolate mofetil, fingolimod and other sphingosine-1-phosphate (S1P) receptor-modulating agents, natalizumab ;
therapy with immunoglobulin drug products within 12 weeks before signing informed consent.
Systemic corticosteroids used within 30 days before signing informed consent;
Hypersensitivity to any of BCD-132 ingredients;
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 anti-CD20 monoclonal antibodies 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 6 weeks before signing informed consent (as told by the patient);
Participation in other clinical studies within 90 days before signing informed consent.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Russia5 sites

City Hospital #15
Moscow
Moscow Regional Research and Clinical Institute
Moscow
Scientific Center of Neurology
Moscow
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022
Institute of the Human Brain n. a. N.P. Bekhtereva Russian Academy of Sciences
Saint Petersburg

Other trials in Russia

About this study

Official title: A Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients With Relapsing-Remitting Multiple Sclerosis

Conditions: Multiple Sclerosis
Being tested: BCD-132
Keywords: BCD-132, Multiple Sclerosis, anti-CD20
Medical subject headings: Multiple Sclerosis

What participants receive

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

BCD-132Biological
Also called humanized monoclonal antibody against CD20
Dose Escalation Study

Study groups in NCT03551275
Study group	Role	What they receive
Cohort no. 1, BCD-132, 100 mg, IV	Experimental	Cohort no. 1, Group #1 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 100 mg. Cohort no. 1, Group #2 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 50 mg and second dose of 50 mg IV after 14 days period after first infusion. If there is no DLT within the first 14 days after infusion then Cohort no.2 is included. Receives: Biological: BCD-132
Cohort no. 2, BCD-132, 250 mg, IV	Experimental	Cohort no. 2, Group #3 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 250 mg. Cohort no. 2, Group #4 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 125 mg and second dose of 125 mg IV after 14 days period after first infusion. If there is no DLT within the first 14 days after infusion then Cohort no.3 is included. Receives: Biological: BCD-132
Cohort no. 3, BCD-132, 500 mg, IV	Experimental	Cohort no. 3, Group #5 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 500 mg. Cohort no. 3, Group #6 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 250 mg and second dose of 250 mg IV after 14 days period after first infusion. If there is no DLT within the first 14 days after infusion then Cohort no.4 is included. Receives: Biological: BCD-132
Cohort no. 4, BCD-132, 1000 mg, IV	Experimental	Cohort no. 4, Group #7 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 1000 mg. Cohort no. 4, Group #8 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 500 mg and second dose of 500 mg IV after 14 days period after first infusion. Receives: Biological: BCD-132

What is being measured

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

The proportion of patients who developed AEs/SAEs that, in the Investigator's opinion, are related to BCD-132
Measured: day 169
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-132
Measured: day 169
The proportion of patients, in each group, who discontinued the study due to AEs/SAEs
Measured: day 169
The proportion of BAb- and NAb-positive patients
Measured: day 169

Secondary outcomes (4)

AUC (0-2016 hours)
Measured: day 85, day 169
AUC (0-∞)
Measured: day 85, day 169
AUEC (0-2016 hours)
Measured: day 85, day 169
AUEC (0-∞)
Measured: day 85, day 169

Timeline

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

22 Feb 201828 Mar 2019

First posted11 Jun 2018
Study start22 Feb 2018
Primary completion18 Oct 2018
Study completion28 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Multiple SclerosisStudies 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 1
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03551275
Sponsor's protocol ID: BCD-132-1
Status last verified: Sep 2021
First submitted: 13 Feb 2018
Last updated: 8 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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

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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: A Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients With Relapsing-Remitting Multiple Sclerosis
ClinicalTrials.gov ID: NCT03551275
Acronym / sponsor ID: BCD-132-1
Conditions: Multiple Sclerosis
Keywords: BCD-132, Multiple Sclerosis, anti-CD20
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: BiocadIndustry (pharma, biotech, devices)
Study start: 22 Feb 2018 (actual)
Primary completion: 18 Oct 2018 (actual)
Study completion: 28 Mar 2019 (actual)
First posted: 11 Jun 2018 (actual)
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: Other
Allocation: Non-randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Cohort no. 1, BCD-132, 100 mg, IV	Experimental	Biological: BCD-132Cohort no. 1, Group #1 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 100 mg. Cohort no. 1, Group #2 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 50 mg and second dose of 50 mg IV after 14 days period after first infusion. If there is no DLT within the first 14 days after infusion then Cohort no.2 is included.
Cohort no. 2, BCD-132, 250 mg, IV	Experimental	Biological: BCD-132Cohort no. 2, Group #3 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 250 mg. Cohort no. 2, Group #4 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 125 mg and second dose of 125 mg IV after 14 days period after first infusion. If there is no DLT within the first 14 days after infusion then Cohort no.3 is included.
Cohort no. 3, BCD-132, 500 mg, IV	Experimental	Biological: BCD-132Cohort no. 3, Group #5 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 500 mg. Cohort no. 3, Group #6 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 250 mg and second dose of 250 mg IV after 14 days period after first infusion. If there is no DLT within the first 14 days after infusion then Cohort no.4 is included.
Cohort no. 4, BCD-132, 1000 mg, IV	Experimental	Biological: BCD-132Cohort no. 4, Group #7 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 1000 mg. Cohort no. 4, Group #8 includes 3 (+3) subjects who will receive the single intravenous infusion of BCD-132 at the dose of 500 mg and second dose of 500 mg IV after 14 days period after first infusion.

Who may qualify

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

Key inclusion criteria (12 listed)

Signed written 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 during this period, 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 (33 listed)

Primary and secondary progressive multiple sclerosis;
Multiple sclerosis duration of more than 10 years with EDSS score ≤2.0 according to screening results;
Other conditions (except for multiple sclerosis) that can affect the assessment of multiple sclerosis 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;

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-132Also: humanized monoclonal antibody against CD20Dose Escalation Study	Biological	Cohort no. 1, BCD-132, 100 mg, IV, Cohort no. 2, BCD-132, 250 mg, IV, Cohort no. 3, BCD-132, 500 mg, IV, Cohort no. 4, BCD-132, 1000 mg, IV

Primary outcome

The proportion of patients who developed AEs/SAEs that, in the Investigator's opinion, are related to BCD-132
Time frame: day 169
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-132
Time frame: day 169
The proportion of patients, in each group, who discontinued the study due to AEs/SAEs
Time frame: day 169
The proportion of BAb- and NAb-positive patients
Time frame: day 169

4 secondary outcomes

AUC (0-2016 hours)
Time frame: day 85, day 169
AUC (0-∞)
Time frame: day 85, day 169
AUEC (0-2016 hours)
Time frame: day 85, day 169
AUEC (0-∞)
Time frame: day 85, day 169

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.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCD-132 in people with Multiple Sclerosis, run by Biocad at 5 sites 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 12 inclusion and 33 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 5 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The proportion of patients who developed AEs/SAEs that, in the Investigator's opinion, are related to BCD-132 (time frame: day 169). The study lists 4 primary outcomes in all. 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 NCT03551275.

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.