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

NCT05242133 | Completed Phase 3

• 2 other identifiers: PEG.CIN.AZ.94.IIIIRCT201612306135N8
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS)

Outcome Measures

Primary Outcomes (1)

• Annualized Relapse Rate

  The total number of relapses divided by the total person-time at risk of relapse. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection.

  96 weeks

Secondary Outcomes (9)

• Proportion of patients with 12 weeks of sustained disability progression

  Baseline up to week 96

• Total number of new or newly enlarging T2-hyperintense lesions as detected by brain MRI

  Baseline up to week 96

• Total number of gadolinium enhancing lesions as detected by brain MRI

  Baseline up to week 96

• Total number of new or newly enlarging T1 hypointense lesions as detected by brain MRI

  Baseline up to week 96

• Total number of new active lesions as detected by brain MRI

  Baseline up to week 96

Other Outcomes (1)

• Number of participants with Adverse Events (AEs)

  96 weeks

Study Arms (2)

CinnaGen peginterferon beta-1a

EXPERIMENTAL

Pegylated interferon beta-1a (CinnaGen) autoinjector (Physioject™),125 mcg, subcutaneous (SC) injection, every 2 weeks, for 24 months

Drug: Pegylated interferon beta-1a

CinnoVex®

ACTIVE COMPARATOR

Interferon Beta-1A Prefilled Syringe, CinnoVex® (CinnaGen), 30 mcg, intramuscular injection, once a week, for 24 months

Drug: Interferon Beta-1A Prefilled Syringe

Interventions

Pegylated interferon beta-1a DRUG

Pegylated interferon beta-1a (CinnaGen) autoinjector (Physioject™),125 mcg, subcutaneous (SC) injection, every 2 weeks, for 24 months

CinnaGen peginterferon beta-1a

Interferon Beta-1A Prefilled Syringe DRUG

Interferon Beta-1A Prefilled Syringe, CinnoVex® (CinnaGen), 30 mcg, intramuscular injection, once a week, for 24 months

Also known as: CinnoVex®

CinnoVex®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cinnagen: lead

Study Sites (1)

Sina Hospital

Tehran, Iran

Location

Related Publications (5)

• Calabresi PA, Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A; ADVANCE Study Investigators. Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65. doi: 10.1016/S1474-4422(14)70068-7. Epub 2014 Apr 30.

  PMID: 24794721 BACKGROUND

• National Multiple Sclerosis Society. (2017). FDA Approves Plegridy (Pegylated Interferon Beta) For Relapsing MS. [online] Available at: http://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Plegridy-Pegylated-Interferon-Beta [Accessed 2 Sep. 2017].

  BACKGROUND

• Anon, (2017). [online] Available at: http://www.cinnagen.com/index.php/our-products/human-medicines/cinnovex [Accessed 2 Sep. 2017].

  BACKGROUND

• Anon, (2017). [online] Available at: National Multiple Sclerosis Society. (2017). FDA Approves Plegridy (Pegylated Interferon Beta) For Relapsing MS. [online] Available at: http://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Plegridy-Pegylated-Interferon-Beta. [Accessed 2 Sep. 2017].

  BACKGROUND

• Shaygannejad V, Ashtari F, Saeidi M, Beladi Moghadam N, Ghalyanchi Langroodi H, Baghbanian SM, Abolfazli R, Ghiasian M, Ayromlou H, Asadollahzadeh E, Sabzvari A, Kafi H, Azimi Saeen A. Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients: A phase 3, randomized, non-inferiority clinical trial (PEGINTEGRITY). Mult Scler Relat Disord. 2024 Oct;90:105839. doi: 10.1016/j.msard.2024.105839. Epub 2024 Aug 20.

  PMID: 39217809 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: February 16, 2022
• Study Start: December 20, 2017
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

IR (1)