Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01707992 | The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) | PHASE3 | COMPLETED | 2,199 | — | — | Feb 20, 2013 | Jul 4, 2017 | Nov 9, 2021 | 284 | United States, Austria +28 |
| NCT00605215 | BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®) | PHASE3 | COMPLETED | 1,331 | — | — | Apr 24, 2008 | Jun 10, 2011 | Apr 21, 2022 | 170 | United States, Bulgaria +17 |
| NCT00509145 | Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS) | PHASE3 | COMPLETED | 1,106 | — | — | Nov 13, 2007 | Nov 8, 2010 | Nov 2, 2021 | 144 | United States, Austria +22 |
Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.
A relapse was defined as the appearance of new neurological abnormalities or the reappearance of previously observed neurological abnormalities; lasting at least 48 hours and immediately preceded by an improved neurological state of ≥30 days from onset of previous relapse, accompanied by observed objective neurological changes (an increase of ≥0.5 in Expanded Disability Status Scale \[EDSS\] score, or an increase of 1 grade in the score of 2 or more of the 7 Functional Systems \[FS\], or an increase of 2 grades in the score of 1 FS as compared to the previous evaluation). Total number of confirmed relapses during the treatment period was divided by the sum of number of days on study in the treatment period and then multiplied by the number of days in the year to calculate the annualized relapse rate. Annualized relapse rate was derived from a baseline-adjusted negative binomial regression.
A relapse was defined as the appearance of at least one new neurological abnormality or the reappearance of at least one previously observed neurological abnormalities lasting greater than or equal to 48 hours and immediately preceded by an improving neurological state of greater than or equal to 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with one or more of the following: An increase of greater than or equal to 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation, an increase of one grade in the actual score of greater than or equal to 2 of the 7 functional systems (FS), as compared to previous evaluation, or an increase of 2 grades in the actual score of one FS as compared to the previous evaluation.
| Arm | Type | Description |
|---|---|---|
| Placebo-Controlled Phase: Placebo | PLACEBO_COMPARATOR | Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams \[mg\]) once daily orally for up to 24 months. |
| Placebo-Controlled Phase: Laquinimod 0.6 mg | EXPERIMENTAL | Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months. |
| Placebo-Controlled Phase: Laquinimod 1.2 mg | EXPERIMENTAL | Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months. |
| Active Treatment Phase: Laquinimod 0.6 mg | EXPERIMENTAL | Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months. |
| Active Treatment Phase: Laquinimod 1.2 mg | EXPERIMENTAL | Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months. |
| Active Treatment Phase: Off Drug | NO_INTERVENTION | Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 will continue the active-treatment phase off drug for 24 months. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 1 capsule of placebo matching to laquinimod orally once daily for 24 months. |
| Laquinimod | EXPERIMENTAL | Participants will receive 1 capsule of laquinimod 0.6 mg orally once daily for 24 months. |
| Avonex® | ACTIVE_COMPARATOR | Participants will receive an injection of Avonex® 30 micrograms (mcg) given intramuscularly (IM) once weekly for 24 months. |
| Name | Type | Description |
|---|---|---|
| Laquinimod | DRUG | Laquinimod will be administered as per the dose and schedule specified in the respective arms. |
| Placebo | DRUG | Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms. |
| Avonex® | DRUG | Avonex® will be administered per dose and schedule specified in the arm description. |
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 scal...