The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT01707992
• Date of registration: 28/09/2012
• Prospective Registration: Yes
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) CONCERTO
• Scientific title: A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
• Date of first enrolment: February 20, 2013
• Target sample size: 2199
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01707992
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, Czechia, Estonia, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Kazakhstan, Korea, Republic of, Latvia, Macedonia, The Former Yugoslav Republic of, Mexico, Moldova, Republic of, Montenegro, North Macedonia, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Spain, Ukraine, United Kingdom, United States

Contacts

• Name: Teva Medical Expert, MD
• Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants must have a confirmed and documented multiple sclerosis (MS) diagnosis as
defined by the Revised McDonald criteria, with relapse onset disease or a
relapsing-remitting disease course.

- Participants must be ambulatory with Kurtzke's expanded disability status scale (EDSS)
score of 0 to 5.5 in both screening and randomization visits.

- Participants must be in a stable neurological condition, relapse-free and free of any
corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os
(PO)/oral] or adrenocorticotrophic hormone, 60 days prior to randomization.

- Participants must have experienced at least one documented relapse in the 12 months
prior to randomization.

- Participants must have disease duration of not more than 15 years.

- Women of child-bearing potential (for example, women who are not postmenopausal or
surgically sterilized) must practice an acceptable method of birth control for 30 days
before taking the study drug and two acceptable methods of birth control during the
duration of the study and until 30 days after the last dose of study medication.

- Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

- Participants with progressive forms of MS.

- Participants with neuromyelitis optica.

- Use of experimental or investigational drugs and/or participation in drug clinical
studies within the 6 months prior to randomization.

- Use of immunosuppressive agents or cytotoxic agents, including cyclophosphamide,
within 6 months prior to randomization.

- Use of either of the following within 2 years prior to randomization visit:
natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.

- Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if
active washout (with either cholestyramine or activated charcoal) was done 2 months or
more prior to randomization.

- Previous treatment with glatiramer acetate (Copaxone®) Interferon ß (either 1a or 1b),
fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulins
within 2 months prior to randomization.

- Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid
treatment within 2 months prior to randomization.

- Previous use of mitoxantrone (Novantrone®), cladribine, or alemtuzumab (Lemtrada®).

- Previous use of laquinimod.

- Previous total body irradiation or total lymphoid irradiation.

- Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone
marrow transplantation.

- Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to
randomization.

- Use of inducers of CYP3A4 within 2 weeks prior to randomization visit.

- Pregnancy or breastfeeding.

- A known history of sensitivity to gadolinium (Gd).

- Inability to successfully undergo magnetic resonance imaging (MRI) scanning.

- Participants who underwent endovascular treatment for chronic cerebrospinal venous
insufficiency within 3 months prior to randomization.

- Additional criteria apply, please contact the investigator for more information.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Laquinimod

Drug: Placebo

Primary Outcome(s)

Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months) [Time Frame: Baseline to Month 24]

Secondary Outcome(s)

Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months) [Time Frame: Baseline to Month 24]

Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 [Time Frame: Baseline, Month 15]

Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months) [Time Frame: Baseline to Month 24]

Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) [Time Frame: Baseline to Month 24]

Secondary ID(s)

2012-003647-30

LAQ-MS-305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01707992