Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple Sclerosis

• Status: Active, not recruiting
• Trial end date: 2022-04-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of peginterferon beta-1a produced by CinnaGen compared with CinnoVex® (CinnaGen) in subjects with relapsing remitting multiple sclerosis (RRMS). All the participants will receive one of the following regimens: pegylated interferon beta-1a (CinnaGen), autoinjector (Physioject™), 125mcg, subcutaneous, every 2 weeks for 24 months or CinnoVex® (CinnaGen), prefilled syringes, 30mcg, intramuscular, once a week for 24 months. The primary objective of this study is to verify the non-inferiority of peginterferon beta-1a (CinnaGen) versus CinnoVex® (CinnaGen) in reducing the annualized relapse rate (ARR) in participants with relapsing remitting multiple sclerosis (RRMS) at 2 years.

The secondary objectives of this study are:

• Reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans

• Slowing the progression of disability

• Comparing adverse events

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cinnagen
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Relapsing-remitting multiple sclerosis diagnosis (based on McDonald criteria 2010)

• Expanded Disability Status Scale between 0 to 5

• At least one relapse having occurred within the past 12 months.

• Subjects have refused alternative treatments and other available therapies

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent

• Negative pregnancy test for women of childbearing age

Exclusion Criteria:

• Primary progressive, secondary progressive, or progressive relapsing MS

• Female subjects considering becoming pregnant while in the study or currently breastfeeding

• Subjects for whom MRI was contraindicated, i.e., who had pacemakers or other contraindicated implanted metal devices, were allergic to gadolinium, or had claustrophobia that could not be medically managed.

• Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental or social) that was likely to affect the subject's ability to comply with the protocol.

• Pre-specified laboratory abnormalities

• History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease that would preclude participation in a clinical trial.

• History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).

• History of seizure disorder or unexplained blackouts or history of a seizure within 3 months prior to baseline.

• History of suicidal ideation within 3 months prior to Baseline or an episode of severe depression within 3 months prior to Baseline. Severe depression is defined as an episode of depression that requires hospitalization, or at the discretion of the Investigator.

• Abnormal screening blood tests exceeding any of the limits defined below:

• Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal (>2 × ULN) or aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) >2 × ULN or bilirubin >1.5 × ULN.

• Total white blood cell count (WBC) <4000 /mm3

• Absolute Neutrophil Count (ANC) of < 1500 /mm3

• Platelet count <150,000 c/mm3

• Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects

• Serum creatinine> upper limit of normal lab value

• A MS relapse that has occurred within the 30 days prior to randomization and/or the subject has not been stabilized from a previous relapse prior to randomization (Day 1).

• Elective surgery performed within 2 weeks prior to randomization (Day 1) or scheduled to be performed through the study interval.

• Treatment with other agents to treat MS symptoms or underlying disease as specified below:

• Agent Time Required off Agent Prior to Baseline:

• Any prior treatment with:

• Total Lymphoid Irradiation

• Cladribine

• T-cell Vaccine

• Natalizumab

• Rituximab

• Plegridy®

• Prior treatment within 1 year of randomization:

• Cyclophosphamide

• Mitoxantrone

• Prior treatment within 6 months prior to randomization:

• Cyclosporine

• Plasma exchange

• Intravenous immunoglobulin (IVIG)

• Azathioprine

• Methotrexate

• Subjects must have discontinued interferon treatment at least 6 months prior to randomization

• Prior treatment within 30 days prior to randomization:

• Systemic corticosteroids

• Prior treatment with glatiramer acetate within 4 weeks prior to randomization

• Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to randomization

• Other unspecified reasons that, in the opinion of the Investigator, made the subject unsuitable for enrolment