Itolizumab for Relapsing Remitting Multiple Sclerosis

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Randomized open label controlled trial to study Safety and Effect of itolizumab (antiCD6) in Relapsing Remitting Multiple Sclerosis.

Secondary indentifying numbers:

IIC RD-EC

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Zurina

Last name:

Lestayo O´Farrill

Medical Specialty :

MD, second degree specialist in Neurology

Affiliation:

Institute of Neurology and Neurosurgery

Postal address:

D Street No. 139 corner 29, Plaza de la Revolución

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78345530

Email address:

zurina@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Clinical Research Direction of CENTIS, Caridad Casaco, MD, first degree specialist in Radiology

Research ethics committees:

Institute of Neurology and Neurosurgery, december 2, 2014

Clinical Research Direction of CENTIS, january 2, 2015

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

15/06/2015

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Relapsing Remitting Multiple Sclerosis

Intervention(s):

Arm 1 Study group (Itolizumab): Itolizumab 1.6 mg/Kg body weight bewekly, (intravenously) by 12 weeks, Itolizumab 1.6 body weight every 4 weeks (intravenously) by 40 weeks. Interferon Arm 2 Study group (Itolizumab): Itolizumab 1.6 mg/Kg body weight bewekly, (intravenously) by 12 weeks, Itolizumab 3.2 body weight every 4 weeks (intravenously) by 40 weeks. Interferon Arm 3 Active Control group (Interferon): Interferon beta-1a (Rebif®) 44 mcg three times a week (subcutaneous) for 52 weeks

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Safety outcomes: Incidence of Adverse Events (AE) (type (name of AE), Intensity (Mild, Moderate, Severe), Gravity (Serious, Not serious), causality relationship (Very Likely, Likely, Possible, Not related, Unknown). Measuring time: 52 weeks.

Key secondary outcomes:

Efficacy outcomes: -Number of clínical relapse. Measuring time: 52 weeks. -Time to relapse (Time in months from baseline until it objectively documented clinical relapse. Measuring time: 52 weeks. -Number of new gadolinium-enhancing lesions. Number of cumulative gadolinium-enhancing lesions. Measuring time: at baseline, 24 and 52 weeks. -Number of new or enlarging T2-hyperintense lesions. Measuring time: at baseline, 24 and 52 weeks. -Sustained disability progression (Change From Baseline in Expanded Disability Status Score (EDSS). Measuring time: at baseline, 12, 24, 39 and 52 weeks. -Time to sustained disability progression (Time in months from baseline until it objectively documented sustained disability progression). Measuring time: 52 weeks. -Proportion of patients free of relapse. Measuring time: at 24 and 52 wweks. -Proportion of patients free of desease. Measuring time: at 24 and 52 weeks. Biodistribution outcomes: -Internal dosimetry Calculation (From the scintigraphic imaging of the central nervous system acquired through methodology MIRD using the software MIRDOSE3). Measuring time: 4 and 24 hours post administration of 99mTc-itolizumab. -Percentage of the administered dose (% ID = Total counts in the organ by 100% / Total counts corresponding to the administered dose) Measurement time: 4 and 24 hours post administration of 99mTc-itolizumab. -Degree of agreement (Agreement between the accumulation of 99mTc-itolizumab and location of lesions in the central nervous system diagnosed by MRI and by scintigraphic studies Gamma Camera). Measuring time: 2h, 4h, 8h and after administration of 24h 99m itolizumab. Immune response outcomes: -Percent subpopulations in peripheral blood lymphoid cells. Measuring Time: Weeks 12, 24, 39 and 52. -Percentage of cytokine expression pattern. Measuring Time: Weeks 12, 24, 39 and 52. -Percentage of lymphocyte activation. Measuring Time: Weeks 12, 24, 39 and 52.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

55 years

Inclusion criteria:

1. Able and willing to give written informed consent. 2. Diagnosis of RRMS, as defined by revised Mc Donald Criteria. 3. MS for at least 1 year. 4. Currently on treatment with interferon beta-1b (IFNβ) within 12 month before randomization. 5. Active RRMS, defined by: ≥ 1 clinical relapse, at 12 previous months on treatment with IFNβ. ≥ 1 gadolinium-enhancing lesión by magnetic resonance imaging (MRI) scans, at baseline. ≥ 1 new T2-hyperintense lesions or FLAIR, compared with previous MRI scans 6. Clinical stability within 30 days before randomization (without steroids). 7. Expanded Disability Status Scale (EDSS) 0 - 5, at baseline. 8. Normal laboratory values at screening: –Hemoglobin-men ≥ 12.0 g/dl, women ≥ 11.0 g/dl; Leucocytes > 5x109 L, Platelets count >150x109/L, Neutrophils > 1.8 x 109/L, Lymphocytes > 1.2x109 cel/mL, . –kidney function: creatinine < < 113 µmol/L. -Liver function: TGP < 49 U/l y TGO < 46 U/l); γ-glutamiltransferasa (GGT), men ≤ 65 U/l, women ≤ 45 U/l) 9. Male or female, aged 18-55 years (both inclusive), no preference will be made based on skin color.

Exclusion criteria:

1. Has diagnosis of primary or secondary progressive or progressive relapsing MS 2. Current use of systemic steroids or immunosuppressive medications within 1 month before randomization 3. Evidence of significant uncontrolled concomitant disease which in the investigator's opinion would preclude patient participation 4. History of malignancy. 5. History of sistemic chronic or acute infection which in the investigator's opinion would preclude patient participation 6. Patients who have been previously treated with monoclonal antibody. 7. History of allergy to chemical or biologicl compounds similar to the experimental product. 8. Pregnancy, childbirth and / or breastfeeding. 9. Patients who refuse to use contraception during the study. 10. Patients with intellectual or psychological dysfunction that not allow to understand and compliance with study requirements, according to the Principal Investigator

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

1-2

Target sample size:

40

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Patricia

Last Name:

Hernandez-Casaña

Specialty:

PhD, Biochemistry. Clinical Research Promoter

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537-2717933

Email :

patriciahc@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Patricia

Last Name:

Hernandez-Casaña

Specialty:

PhD, Biochemistry. Clinical Research Promoter

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537 2717933

Email :

patriciahc@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000197

Date of Registration in Primary Registry:

22/05/2015

Record Verification Date:

2015/05/22

Next update date:

2016/05/22

Link to the spanish version:

Click here

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Ensayos Registrados

Proceso de Registro

Itolizumab for Relapsing Remitting Multiple Sclerosis

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