5354W-12 The Efficacy and Safety and Tolerability of Laquinimod in Subjects With Relapsing Remitting

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

Type of Study
Neuroscience - Multiple Sclerosis
Short Description
This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod 0.6 mg/day or 1.2mg/day in subjects with RRMS.
 
Status
Open
Principal Investigator
Peiqing Qian, MD
Eligibility Notes

Key Inclusion criteria:

  • Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
  • Subjects must be ambulatory with Kurtzke EDSS score of 0- 5.5 in both screening and randomization visits.
  • Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
  • Subjects must have experienced at least one documented relapse in the 12 months prior to randomization.
  • Subjects must be between 18 and 55 years of age at screening, inclusive.
  • Subjects must have disease duration of at least 6 months, but not more than 12 years (from the first symptom) prior to randomization.

Key exclusion criteria:
 
  • Subjects with progressive forms of MS.
  • Use of either of the following within 2 years prior to screening visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.
  • Previous treatment with glatiramer acetate (Copaxone®) Interferon-β (either 1a or 1b) or intravenous immunoglobulin (IVIG) 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(CAMPATH-1H).
 

Contact Name
Beena Gangadharan and Caryl Tongco
Phone
206-320-2633
Alternate Phone
206-215-3565
Email
Beena.gangadharan@swedish.org
Alternate Email
Caryl.tongco@swedish.org