A Phase 3 interventional study of Laquinimod and Placebo in Multiple Sclerosis, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 284 sites in 30 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment
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 in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 2,199 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 206 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women of (for example, women who are not or surgically sterilized) must practice an acceptable method of 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.
Exclusion Criteria:
Participants who underwent endovascular treatment for chronic cerebrospinal venous insufficiency within 3 months prior to randomization.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams \[mg\]) once daily orally for up to 24 months.
Drug: Placebo
Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
Drug: Laquinimod · Drug: Placebo
Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.
Drug: Laquinimod
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.
Drug: Laquinimod · Drug: Placebo
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.
Drug: Laquinimod
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.
Laquinimod will be administered as per the dose and schedule specified in the respective arms.
Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.
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 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.
Time frame: Baseline to Month 24
Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15
Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.
Time frame: Baseline, Month 15
Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)
Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 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 an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).
Time frame: Baseline to Month 24
Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)
Time to CDP was defined as the time to a sustained increase in Kurtzke's 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 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.
Time frame: Baseline to Month 24
Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)
Time to CDP was defined as the time to a sustained increase in Kurtzke's 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 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.
Time frame: Baseline to Month 24
Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Time frame: Baseline up to Month 24
Active-Treatment Phase: Number of Participants With AEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities
Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (\>=) 120 beats per minute (bpm) and increase from baseline of \>=30 bpm, \<=45 bpm and decrease from baseline of \>=30 bpm; Systolic blood pressure: \>=180 millimeters of mercury (mmHg) and increase from baseline of \>=30 mmHg, \<=90 and decrease from baseline of \>=30 mmHg; Diastolic blood pressure: \>=100 mmHg and increase from baseline of \>=20 mmHg, \<=50 mmHg and decrease from baseline of \>=20 mmHg.
Time frame: Baseline up to Week 24
Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities
Clinically significant vital signs abnormalities included: Pulse rate: \>=120 bpm and increase from baseline of \>=30 bpm, \<=45 bpm and decrease from baseline of \>=30 bpm; Systolic blood pressure: \>=180 mmHg and increase from baseline of \>=30 mmHg, \<=90 and decrease from baseline of \>=30 mmHg; Diastolic blood pressure: \>=100 mmHg and increase from baseline of \>=20 mmHg, \<=50 mmHg and decrease from baseline of \>=20 mmHg.
Time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.
Time frame: Baseline, Endpoint (Month 24)
Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters
ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.
Time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)
Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry
Potentially clinically significant serum chemistry abnormalities included: Glucose \<=3 and \>=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter \[U/L\]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter \[mg/L\]), pancreatic amylase (in U/L)\>=3 \* upper limit of normal (ULN); Fibrinogen \>=6 grams per liter (gm/L); Sodium \<=130 and \>=150 mmol/L; Potassium \<=3.2 and \>=5.5 mmol/L; Calcium \<=1.87 and \>=2.75 mmol/L; Phosphate \<=0.65 and \>=1.61 mmol/L.
Time frame: Baseline up to Month 24
Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry
Potentially clinically significant serum chemistry abnormalities included: Glucose \<=3 and \>=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)\>=3 \* ULN; Fibrinogen \>=6 gm/L; Sodium \<=130 and \>=150 mmol/L; Potassium \<=3.2 and \>=5.5 mmol/L; Calcium \<=1.87 and \>=2.75 mmol/L; Phosphate \<=0.65 and \>=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin \>=28 micromols per liter (micromols/L); Creatinine \>=117 micromols/L; Albumin \<=25 gm/L.
Time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values
Potentially clinically significant hematological abnormalities included: Hemoglobin \<=11.5 grams per deciliter (gm/dL) in males and \<=10 gm/dL in females; White blood cells (WBCs) count \<=2.5 and \>=21\*10\^9 per liter (L); Absolute neutrophil count (ANC) \<=1.49\*10\^9 per L; Platelet count \<=100 and \>=600\*10\^9 per L.
Time frame: Baseline up to Month 24
Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values
Potentially clinically significant hematological abnormalities included: Hemoglobin \<=11.5, \>=20 gm/dL in males, and \<=10, \>=18.5 gm/dL in females; WBCs count \<=2.5 and \>=21\*10\^9 per L; ANC \<=1.49\*10\^9 per L; Platelet count \<=100 and \>=600\*10\^9 per L.
Time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
| Milestone | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Active Treatment Phase: Laquinimod 0.6 mg | Active Treatment Phase: Laquinimod 1.2 mg | Active Treatment Phase: Off Drug |
|---|---|---|---|---|---|---|
| Started | 740 | 727 | 732 | 0 | 0 | 0 |
| Completed | 596 | 623 | 532 | 0 | 0 | 0 |
| Not completed | 144 | 104 | 200 | 0 | 0 | 0 |
| Withdrew: Adverse event | 8 | 13 | 9 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 10 | 3 | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 88 | 68 | 154 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Pregnancy | 12 | 5 | 9 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 10 | 4 | 9 | 0 | 0 | 0 |
| Withdrew: Death | 2 | 1 | 1 | 0 | 0 | 0 |
| Withdrew: Noncompliance with drug administration | 2 | 1 | 6 | 0 | 0 | 0 |
| Withdrew: Other than specified | 11 | 9 | 10 | 0 | 0 | 0 |
| Milestone | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Active Treatment Phase: Laquinimod 0.6 mg | Active Treatment Phase: Laquinimod 1.2 mg | Active Treatment Phase: Off Drug |
|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 891 | 504 | 215 |
| Completed | 0 | 0 | 0 | 7 | 10 | 0 |
| Not completed | 0 | 0 | 0 | 884 | 494 | 215 |
| Withdrew: Adverse event | 0 | 0 | 0 | 4 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 3 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 58 | 220 | 32 |
| Withdrew: Pregnancy | 0 | 0 | 0 | 2 | 5 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 5 | 11 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 2 | 0 | 0 |
| Withdrew: Other than specified | 0 | 0 | 0 | 1 | 5 | 2 |
| Withdrew: Noncompliance | 0 | 0 | 0 | 0 | 4 | 2 |
| Withdrew: Study terminated by sponsor | 0 | 0 | 0 | 809 | 243 | 174 |
| Withdrew: Participant withdrew per sponsor request | 0 | 0 | 0 | 0 | 4 | 0 |
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.
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| 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) | 73 | 66 | 69 |
Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.
| percent change | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15 | -0.8 ± 1.02 | -0.4 ± 1.01 | -0.4 ± 1.05 |
Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 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 an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse) | 332 | 269 | 222 |
Time to CDP was defined as the time to a sustained increase in Kurtzke's 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 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months) | 49 | 49 | 51 |
Time to CDP was defined as the time to a sustained increase in Kurtzke's 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 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months) | 38 | 38 | 39 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs) | 546 | 565 | 575 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
| Participants | Active Treatment Phase: Laquinimod 0.6 mg | Active Treatment Phase: Laquinimod 1.2 mg |
|---|---|---|
| Active-Treatment Phase: Number of Participants With AEs | 442 | 241 |
Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (\>=) 120 beats per minute (bpm) and increase from baseline of \>=30 bpm, \<=45 bpm and decrease from baseline of \>=30 bpm; Systolic blood pressure: \>=180 millimeters of mercury (mmHg) and increase from baseline of \>=30 mmHg, \<=90 and decrease from baseline of \>=30 mmHg; Diastolic blood pressure: \>=100 mmHg and increase from baseline of \>=20 mmHg, \<=50 mmHg and decrease from baseline of \>=20 mmHg.
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | 21 | 21 | 29 |
Clinically significant vital signs abnormalities included: Pulse rate: \>=120 bpm and increase from baseline of \>=30 bpm, \<=45 bpm and decrease from baseline of \>=30 bpm; Systolic blood pressure: \>=180 mmHg and increase from baseline of \>=30 mmHg, \<=90 and decrease from baseline of \>=30 mmHg; Diastolic blood pressure: \>=100 mmHg and increase from baseline of \>=20 mmHg, \<=50 mmHg and decrease from baseline of \>=20 mmHg.
| Participants | Active Treatment Phase: Laquinimod 0.6 mg | Active Treatment Phase: Laquinimod 1.2 mg |
|---|---|---|
| Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities | 17 | 7 |
ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Normal - Normal | 463 | 467 | 470 |
| Normal - Abnormal NCS | 139 | 124 | 126 |
| Normal - Abnormal CS | 0 | 6 | 5 |
| Abnormal NCS - Normal | 32 | 27 | 28 |
| Abnormal NCS - Abnormal NCS | 98 | 96 | 90 |
| Abnormal NCS - Abnormal CS | 1 | 1 | 2 |
| Abnormal CS - Normal | 0 | 1 | 0 |
| Abnormal CS - Abnormal NCS | 0 | 0 | 0 |
| Abnormal CS - Abnormal CS | 1 | 1 | 3 |
ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.
| Participants | Active Treatment Phase: Laquinimod 0.6 mg | Active Treatment Phase: Laquinimod 1.2 mg |
|---|---|---|
| Normal - Normal | 641 | 353 |
| Normal - Abnormal NCS | 137 | 80 |
| Normal - Abnormal CS | 7 | 5 |
| Abnormal NCS - Normal | 18 | 17 |
| Abnormal NCS - Abnormal NCS | 81 | 45 |
| Abnormal NCS - Abnormal CS | 4 | 0 |
| Abnormal CS - Normal | 0 | 0 |
| Abnormal CS - Abnormal NCS | 0 | 0 |
| Abnormal CS - Abnormal CS | 0 | 1 |
Potentially clinically significant serum chemistry abnormalities included: Glucose \<=3 and \>=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter \[U/L\]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter \[mg/L\]), pancreatic amylase (in U/L)\>=3 \* upper limit of normal (ULN); Fibrinogen \>=6 grams per liter (gm/L); Sodium \<=130 and \>=150 mmol/L; Potassium \<=3.2 and \>=5.5 mmol/L; Calcium \<=1.87 and \>=2.75 mmol/L; Phosphate \<=0.65 and \>=1.61 mmol/L.
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry | 157 | 165 | 187 |
Potentially clinically significant serum chemistry abnormalities included: Glucose \<=3 and \>=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)\>=3 \* ULN; Fibrinogen \>=6 gm/L; Sodium \<=130 and \>=150 mmol/L; Potassium \<=3.2 and \>=5.5 mmol/L; Calcium \<=1.87 and \>=2.75 mmol/L; Phosphate \<=0.65 and \>=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin \>=28 micromols per liter (micromols/L); Creatinine \>=117 micromols/L; Albumin \<=25 gm/L.
| Participants | Active Treatment Phase: Laquinimod 0.6 mg | Active Treatment Phase: Laquinimod 1.2 mg |
|---|---|---|
| Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry | 887 | 501 |
Potentially clinically significant hematological abnormalities included: Hemoglobin \<=11.5 grams per deciliter (gm/dL) in males and \<=10 gm/dL in females; White blood cells (WBCs) count \<=2.5 and \>=21\*10\^9 per liter (L); Absolute neutrophil count (ANC) \<=1.49\*10\^9 per L; Platelet count \<=100 and \>=600\*10\^9 per L.
| Participants | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg |
|---|---|---|---|
| Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values | 71 | 78 | 83 |
Potentially clinically significant hematological abnormalities included: Hemoglobin \<=11.5, \>=20 gm/dL in males, and \<=10, \>=18.5 gm/dL in females; WBCs count \<=2.5 and \>=21\*10\^9 per L; ANC \<=1.49\*10\^9 per L; Platelet count \<=100 and \>=600\*10\^9 per L.
| Participants | Active Treatment Phase: Laquinimod 0.6 mg | Active Treatment Phase: Laquinimod 1.2 mg |
|---|---|---|
| Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values | 886 | 499 |
Collected over Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo-Controlled Phase: Laquinimod 0.6 mg | 1/727 (0.1%) | 57/727 (7.8%) | 262/727 (36%) |
| Placebo-Controlled Phase: Laquinimod 1.2 mg | 1/732 (0.1%) | 49/732 (6.7%) | 286/732 (39.1%) |
| Placebo-Controlled Phase: Placebo | 2/740 (0.3%) | 43/740 (5.8%) | 243/740 (32.8%) |
| Active Treatment Phase: Early Laquinimod 0.6 mg | 2/580 (0.3%) | 24/580 (4.1%) | 102/580 (17.6%) |
| Active Treatment Phase: Early Laquinimod 1.2 mg | 0/268 (0%) | 10/268 (3.7%) | 46/268 (17.2%) |
| Active Treatment Phase: Off Drug | 0/215 (0%) | 5/215 (2.3%) | 35/215 (16.3%) |
| Active Treatment Phase: From Placebo to Laquinimod 0.6 mg | 0/311 (0%) | 5/311 (1.6%) | 43/311 (13.8%) |
| Active Treatment Phase: From Placebo to Laquinimod 1.2 mg | 0/236 (0%) | 9/236 (3.8%) | 43/236 (18.2%) |
| Event | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Placebo-Controlled Phase: Placebo | Active Treatment Phase: Early Laquinimod 0.6 mg | Active Treatment Phase: Early Laquinimod 1.2 mg | Active Treatment Phase: Off Drug | Active Treatment Phase: From Placebo to Laquinimod 0.6 mg | Active Treatment Phase: From Placebo to Laquinimod 1.2 mg |
|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis relapseNervous system disorders | 2/727 | 1/732 | 7/740 | 2/580 | 1/268 | 0/215 | 0/311 | 0/236 |
| Uterine leiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 5/727 | 0/732 | 2/740 | 1/580 | 0/268 | 0/215 | 0/311 | 0/236 |
| Acute myocardial infarctionCardiac disorders | 0/727 | 4/732 | 0/740 | 1/580 | 1/268 | 1/215 | 0/311 | 0/236 |
| PancreatitisGastrointestinal disorders | 0/727 | 4/732 | 0/740 | 0/580 | 0/268 | 0/215 | 0/311 | 0/236 |
| Coronary artery occlusionCardiac disorders | 0/727 | 0/732 | 0/740 | 0/580 | 0/268 | 1/215 | 0/311 | 0/236 |
| Blood creatine phosphokinase increasedInvestigations | 0/727 | 0/732 | 0/740 | 0/580 | 0/268 | 1/215 | 0/311 | 0/236 |
| Metastases to central nervous systemNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/727 | 0/732 | 0/740 | 0/580 | 0/268 | 1/215 | 0/311 | 0/236 |
| Metastases to chest wallNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/727 | 0/732 | 0/740 | 0/580 | 0/268 | 1/215 | 0/311 | 0/236 |
| Haemorrhagic strokeNervous system disorders | 0/727 | 0/732 | 0/740 | 0/580 | 0/268 | 1/215 | 0/311 | 0/236 |
| HospitalisationSurgical and medical procedures | 0/727 | 0/732 | 0/740 | 0/580 | 0/268 | 1/215 | 0/311 | 0/236 |
| Event | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Placebo-Controlled Phase: Placebo | Active Treatment Phase: Early Laquinimod 0.6 mg | Active Treatment Phase: Early Laquinimod 1.2 mg | Active Treatment Phase: Off Drug | Active Treatment Phase: From Placebo to Laquinimod 0.6 mg | Active Treatment Phase: From Placebo to Laquinimod 1.2 mg |
|---|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 122/727 | 131/732 | 116/740 | 22/580 | 8/268 | 10/215 | 14/311 | 10/236 |
| Back painMusculoskeletal and connective tissue disorders | 54/727 | 85/732 | 39/740 | 12/580 | 8/268 | 9/215 | 1/311 | 12/236 |
| NasopharyngitisInfections and infestations | 63/727 | 60/732 | 63/740 | 40/580 | 14/268 | 8/215 | 11/311 | 11/236 |
| AnaemiaBlood and lymphatic system disorders | 28/727 | 43/732 | 30/740 | 22/580 | 13/268 | 7/215 | 9/311 | 9/236 |
| Respiratory tract infection viralInfections and infestations | 32/727 | 31/732 | 39/740 | 14/580 | 7/268 | 3/215 | 3/311 | 5/236 |
| Amylase increasedInvestigations | 17/727 | 38/732 | 18/740 | 6/580 | 2/268 | 2/215 | 6/311 | 5/236 |
Intent-to-treat (ITT) analysis set included all randomized participants.
| Age, Continuous(years) | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Total |
|---|---|---|---|---|
| Mean | 35.9 ± 8.95 | 36.8 ± 9.25 | 36.1 ± 9.22 | 36.3 ± 9.14 |
| Age, Customized(Participants) | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Total |
|---|---|---|---|---|
| Adults (18-64 years) | 740 | 727 | 732 | 2199 |
| Sex: Female, Male(Participants) | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Total |
|---|---|---|---|---|
| Female | 488 | 510 | 475 | 1473 |
| Male | 252 | 217 | 257 | 726 |
| Race(Participants) | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Total |
|---|---|---|---|---|
| White | 724 | 712 | 717 | 2153 |
| Black | 3 | 3 | 3 | 9 |
| Asian | 3 | 2 | 3 | 8 |
| Other | 10 | 8 | 9 | 27 |
| Missing | 0 | 2 | 0 | 2 |
| Kurtzke's Expanded Disability Status Scale (EDSS) Score(Participants) | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Total |
|---|---|---|---|---|
| Less than or equal to (<=) 4.0 | 653 | 635 | 644 | 1932 |
| Greater than (>) 4.0 | 87 | 90 | 88 | 265 |
| Missing | 0 | 2 | 0 | 2 |
| Normalized Brain Volume(milliliters (mL)) | Placebo-Controlled Phase: Placebo | Placebo-Controlled Phase: Laquinimod 0.6 mg | Placebo-Controlled Phase: Laquinimod 1.2 mg | Total |
|---|---|---|---|---|
| Mean | 1437.2 ± 93.37 | 1433.0 ± 92.49 | 1434.4 ± 93.41 | 1434.9 ± 93.07 |
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Studies of the drug tested here: Laquinimod
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