A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

NCT01975298 | Withdrawn Phase 3 DMC

• 2 other identifiers: LAQ-MS-3062013-002082-19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the efficacy, safety, and tolerability of two doses of laquinimod compared to Avonex®

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

RRMS

Outcome Measures

Primary Outcomes (1)

• Brain Atrophyas observed by Magnetic Resonance Imaging (MRI)

  This is assessed by an MRI and is a measure of brain volume

  Baseline and Month 12.

Secondary Outcomes (3)

• The cumulative number of reported influenza-like symptoms

  Baseline to Month 3

• Cumulative number of new T2 lesions observed by Magnetic Resonance Imaging (MRI) between the 2 laquinimod doses

  Baseline, Month 6 and Month 12

• Summary of Participant with Adverse Events

  12 Months

Study Arms (3)

Laquinimod 0.6 mg

EXPERIMENTAL

Drug: Laquinimod

Laquinimod 1.2 mg

EXPERIMENTAL

Drug: Laquinimod

Avonex®

ACTIVE COMPARATOR

Drug: Avonex®

Interventions

Laquinimod DRUG

Oral Administration

Also known as: TV-5600

Laquinimod 0.6 mg; Laquinimod 1.2 mg

Avonex® DRUG

Interferon β1A 30 μg/0.5mL administered Intra Muscular

Also known as: Interferon β1A

Avonex®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
• Subjects must be ambulatory with an Kurtzke EDSS score of 0-5.5 at both Screening and Baseline (randomization) visits.
• Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment (intravenous \[IV\], IM and/or per os \[PO\]) or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
• Subjects must have experienced at least 1 documented relapse in the last year prior to randomization or 2 relapses in the last 3 years prior to randomization.
• Subjects must be between 18 and 55 years of age at screening, inclusive.
• Women of child-bearing potential must practice an acceptable method of birth control until 30 days after the last dose of treatment was administered (acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive or double-barrier method \[condom or diaphragm with spermicide\]).
• Subjects must be able to sign and date a written informed consent prior to entering the study.
• Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
• other criteria may apply, please contact the investigator for more information

You may not qualify if:

• Subjects with progressive forms of MS.
• Subjects with Neuromyelitis Optica (NMO).
• Use of experimental or investigational drugs and/or participation in drug clinical studies within 6 months prior to Baseline visit (randomization).
• Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azatioprine within 12 months prior to Baseline.
• Natalizumab (Tysabri®) if given more than 6 months prior to randomization AND the subject is John Cunningham (JC) virus antibody test negative at Screening.
• Previous use of Rituximab, ocrelizumab, or ofatumumab is allowed if the B cell count (CD19) is higher than 80 cells /μL.
• Previous treatment with glatiramer acetate (Copaxone®e), fingolimod (Gilenya®), BG-12 (Tecfidera), Teriflunomide (Aubagio®) or intravenous immunoglobulin (IVIG) within 2 months prior to Baseline.
• Use of mitoxantrone (Novantrone) within 5 years prior to Screening. Use of mitoxantrone (Novantrone) \>5 years before screening is allowed in subjects with normal ejection fraction and who did not exceed the total lifetime maximal dose.
• Chronic (more than 30 consecutive days or monthly dosing, eg, with the intent of MS disease modification) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to Baseline.
• Previous use of cladribine.
• Previous use of laquinimod or Avonex® IM.
• Treatment with other Interferon-β (either 1a subcutaneous \[SC\] or 1b SC) within 60 days before baseline (earlier treatment will be allowed if the reason for discontinuation was not treatment failure or for Interferon-β related safety reasons. This decision will be taken by the investigator).
• Previous total body irradiation or total lymphoid irradiation.
• Previous stem cell treatment, autologous bone marrow transplantation, or allogenic bone marrow transplantation.
• Acute infection within 2 weeks prior to Baseline visit.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

laquinimod; Interferon beta-1a

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

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Medical Director, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 4, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: November 9, 2021

Record last verified: 2021-11