| Primary | Difference Between 45 mg/Day IMU-838 and Placebo in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions | MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of gadolinium enhancing (Gd+) lesions (0, ≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. Log transformation of time from first IMP dose to date of last MRI assessment was used as offset term. Mainly due to the differing number of patients with 3.0 Tesla MRI examinations in each treatment arm, the statistical adjustments (to ensure comparabiltiy) for each individual comparison differed and hence the adjusted mean cumulative number of CUA MRI lesions in each arm (e.g. placebo) differed depending on the comparison (45 mg IMU-838 vs placebo, 30 mg IMU-838 vs placebo, or 45 mg vs 30 mg IMU-838). | FAS consisting of all randomized patients who received at least 1 dose of the investigational medicinal product (IMP). | Posted | | Mean | 95% Confidence Interval | CUA MRI lesions | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002.4(1.1 to 4.9)
- OG0016.3(2.8 to 13.9)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| H0: cumulative number of CUA MRI lesions up to Week 24 with 45 mg IMU-838 equal to or higher than that with placebo. A generalized linear model with a negative binomial distribution and logarithmic link function was used. Log transformation of time from 1st IMP dose to date of last MRI assessment was used as offset term. 51 patients per group were necessary to have 80% power to detect a difference of 3.5 in mean event rate with a significance level 0.1, 1-sided. | generalized linear model | Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1). | 0.0002 | A one-sided alpha level of 0.1 was used. | rate ratio | 0.38 | | | 2-Sided | 95 | 0.22 | 0.64 | | | |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions | This was the key secondary endpoint (hierarchical testing to primary efficacy). MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. Log transformation of time from first IMP dose to date of last MRI assessment was used as offset term. Mainly due to the differing number of patients with 3.0 Tesla MRI examinations in each treatment arm, the statistical adjustments (to ensure comparabiltiy) for each individual comparison differed and hence the adjusted mean cumulative number of CUA MRI lesions in each arm (e.g. placebo) differed depending on the comparison (45 mg IMU-838 vs placebo, 30 mg IMU-838 vs placebo, or 45 mg vs 30 mg IMU-838). | FAS consisting of all randomized patients who received at least 1 dose of the IMP. | Posted | | Mean | 95% Confidence Interval | CUA MRI lesions | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | Placebo | |
|
| Secondary | Difference Between 45 mg/Day IMU-838 and 30 mg/Day IMU-838 in the Cumulative Number of Combined Unique Active (CUA) MRI Lesions | MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. Log transformation of time from first IMP dose to date of last MRI assessment was used as offset term. Mainly due to the differing number of patients with 3.0 Tesla MRI examinations in each treatment arm, the statistical adjustments (to ensure comparabiltiy) for each individual comparison differed and hence the adjusted mean cumulative number of CUA MRI lesions in each arm (e.g. placebo) differed depending on the comparison (45 mg IMU-838 vs placebo, 30 mg IMU-838 vs placebo, or 45 mg vs 30 mg IMU-838). | FAS consisting of all randomized patients who received at least 1 dose of the investigational medicinal product. | Posted | | Mean | 95% Confidence Interval | CUA MRI lesions | | At Week 24 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Mean Number of CUA Lesions Per Patient Per Scan at Weeks 6, 12, 18 and 24 | MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for MRI field strength (1.5 or 3.0 Tesla) and baseline number of Gd+ lesions (0,≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. | | Posted | | Mean | 95% Confidence Interval | CUA MRI lesions | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Cumulative Number of CUA MRI Lesions up to Weeks 6, 12, and 18 | MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for baseline volume of T2 lesions, MRI field strength (1.5 or 3.0 Tesla), and baseline number of Gd+ lesions (0, ≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. Log transformation of time from first IMP dose to date of last MRI assessment was used as offset term. | | Posted | | Mean | 95% Confidence Interval | CUA MRI lesions | | Throughout the main treatment period (Day 0 - Week 18) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Volume Changes of T2 Lesions at Weeks 6, 12, 18 and 24 Compared to Baseline | The endpoint was removed in the statistical analysis plan [SAP], since the content was considered the same as the endpoint "T2-lesion load at Weeks 6, 12, 18 and 24 compared to Baseline". | This measure was not analyzed because it was determined to be redundant with Outcome Measure 7. No data are available to be reported. | Posted | | | | | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the T2-lesion Load at Weeks 6, 12, 18 and 24 Compared to Baseline | MRI scans were assessed centrally and adhered to a standardized MRI protocol. The percentage change from Baseline in T2 lesion load was calculated. | | Posted | | Median | 95% Confidence Interval | % change from Baseline | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the T1-lesion Load at Weeks 6, 12, 18 and 24 Compared to Baseline | MRI scans were assessed centrally and adhered to a standardized MRI protocol. The percentage change from Baseline in T1 lesion load was calculated. | | Posted | | Median | 95% Confidence Interval | % change from Baseline | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Cumulative Number of New Gd+ Lesions up to Weeks 6, 12, 18 and 24 | MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for MRI field strength (1.5 or 3.0 Tesla) and baseline number of Gd+ lesions (0, ≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. Log transformation of time from first IMP dose to date of last MRI assessment was used as offset term. | | Posted | | Mean | 95% Confidence Interval | Gd+ lesions | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Cumulative Number of New T2 Lesions up to Weeks 6, 12, 18 and 24 | MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for MRI field strength (1.5 or 3.0 Tesla) and baseline number of Gd+ lesions (0, ≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. Log transformation of time from first IMP dose to date of last MRI assessment was used as offset term. | | Posted | | Mean | 95% Confidence Interval | T2 lesions | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Cumulative Number of New T1 Lesions up to Weeks 6, 12, 18 and 24 | MRI scans were assessed centrally and adhered to a standardized MRI protocol. Estimates were adjusted for MRI field strength (1.5 or 3.0 Tesla) and baseline number of Gd+ lesions (0, ≥1) using a generalized linear model with a negative binomial distribution and a logarithmic link function. Log transformation of time from first IMP dose to date of last MRI assessment was used as offset term. | | Posted | | Mean | 95% Confidence Interval | T1 lesions | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Number of Patients Without New Gd+ Lesions Over 24 Weeks | MRI scans were assessed centrally and adhered to a standardized MRI protocol. The number of patients who did not develop new Gd+ lesions over the 24-week main treatment period was assessed. | | Posted | | Count of Participants | | Participants | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Number of Patients Without New or Enlarging T2-weighted Lesions Over 24 Weeks | MRI scans were assessed centrally and adhered to a standardized MRI protocol. The number of patients who did not develop new or enlarging T2 lesions over the 24-week main treatment period was assessed. | | Posted | | Count of Participants | | Participants | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Number of Patients With CUA Lesions at Week 24 | MRI scans were assessed centrally and adhered to a standardized MRI protocol. The number of patients with CUA lesions at Week 24 was assessed. | Patients with observations at Week 24 | Posted | | Count of Participants | | Participants | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Number of Patients With Gd+ Lesions at Week 24 | MRI scans were assessed centrally and adhered to a standardized MRI protocol. The number of patients with Gd+ lesions at Week 24 was assessed. | Patients with observations at Week 24. | Posted | | Count of Participants | | Participants | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for the Number of Patients With T2 Lesions at Week 24 | MRI scans were assessed centrally and adhered to a standardized MRI protocol. The number of patients with T2 lesions at Week 24 was assessed. | Patients with observations in this analysis. | Posted | | Count of Participants | | Participants | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Differences Between Individual Treatments and Between the Pooled 30 mg/Day and 45 mg/Day Groups and Placebo in the Relapse-related Clinical Endpoints: Mean Annualized Relapse Rate (During Main and Extended Treatment Period) | The adjusted mean annualized relapse rate during the main treatment period was calculated. Estimates were adjusted for baseline number of Gd+ lesions (0, ≥1) using a Poisson model with a logarithmic link function. Log transformation of real exposure time of main treatment period was used as offset term. All of the following criteria had to be met for a clinical event to qualify as a relapse:
-
Neurological deficit, either newly appearing or re-appearing, with abnormality specified by both neurological abnormality separated by at least 30 days from onset of a preceding relapse AND neurological abnormality lasting for at least 24 hours
-
Absence of fever or known infection (i.e. temperature [axillary, oral, or intra-auricular]
≤37.5ºC)
-
Neurological impairment, defined as either increase in at least one of the functional systems of the EDSS OR increase of the total EDSS score. In both cases, the increase in EDSS had to correlate with the patient's reported symptoms.
| | Posted | | Mean | 95% Confidence Interval | relapses per person-years | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | |
|
| Secondary | Differences Between Individual Treatments and Between the Pooled 30 mg/Day and 45 mg/Day Groups and Placebo in the Relapse-related Clinical Endpoints: Proportion of Relapse-free Patients up to Week 24 and at Extended Periods Thereafter | The proportion of relapse-free patients up to Week 24 was assessed. Patients with no documented relapse and last assessment of relapse before Week 18 were not included. Patients with no documented relapse up to Week 18 and a missing assessment at Week 24 were regarded as relapse-free patients. | | Posted | | Count of Participants | | Participants | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo |
|
| Secondary | Differences Between Individual Treatments and Between the Pooled 30 mg/Day and 45 mg/Day Groups and Placebo in the Relapse-related Clinical Endpoints: Time to Relapse at Time of Final Analysis of Main Part | Since only a total of 39 of 209 patients had a relapse up to Week 24, the median time to relapse could not be calculated. | | Posted | | Median | Full Range | days | | Throughout the main treatment period (Day 0 - Week 24) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Differences Between Treatments in Changes of Disease Activity as Measured by the Mean Change in the Expanded Disability Status Scale (EDSS) as Compared to Baseline During the Main and Extended Period (Every 12 Weeks Starting at Week 12) | The EDSS is a widely used and validated instrument evaluating the functional systems of the CNS to describe disease progression and the efficacy of MS therapy. The composite rating system ranges from 0 (normal neurological status) to 10 (death due to MS) in 0.5-unit increments. An increase in score indicates a worsening. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Week 12, and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo |
|
| Secondary | Differences Between Treatments in Changes of Disease Activity as Measured by the Number of Patients With EDSS Progression During the Main and Extended Period (Every 12 Weeks Starting at Week 12, and Cumulatively) | The EDSS is a widely used and validated instrument evaluating the functional systems of the CNS to describe disease progression and the efficacy of MS therapy. The composite rating system ranges from 0 (normal neurological status) to 10 (death due to MS) in 0.5-unit increments. EDSS progression was defined as an increase of the EDSS score compared to Baseline of at least 1.0 point for patients with a baseline EDSS score of 1 to 4.0 or of at least 1.5 points for patients with a baseline EDSS score of 0. | | Posted | | Count of Participants | | Participants | | Week 12 and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Correlation of MRI-based Assessments With Quartiles of IMU-838 Trough Levels | The cumulative number of CUA MRI lesions up to Week 24 was correlated with quartiles of IMU-838 trough levels at Week 24 of treatment groups IMU-838 30 mg and IMU-838 45 mg. | Patients with observations. | Posted | | Mean | Standard Deviation | CUA MRI lesions | | At Week 24 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Number of Participants With AEs | The number of patients experiencing treatment-emergent adverse events during the main treatment period was assessed. | Safety analysis set consisting of all randomized patients who received at least 1 dose of IMP. | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Number of Participants With Serious AEs | The number of patients experiencing serious adverse events during the main treatment period was assessed. | | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities (as Assessed by the Investigator) | Abnormal results in laboratory assessments were assessed by the investigator and classified as clinically significant (yes/no). Clinically significantly abnormal values had to be reported as AE, if not already clinically significantly abnormal at Baseline. Treatment-emergent adverse events related to hematological abnormalities and clinical chemistry abnormalities are reported. | | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Number of Participants With AEs of Special Interest: Red Blood Cell Urine Positive, at Least of Moderate Intensity | The number of patients diagnosed with red blood cell (RBC) urine positive of at least moderate intensity during the main treatment period were assessed. The evaluation of RBC in urine was to be solely based on findings from microscopic examinations of urinary sediment and not from dipstick reading only. Therefore, all conspicuous dipstick readings were to be followed up by a microscopic examination of urinary sediment. All findings of RBC in urine per high-powered field (HPF) were to be listed as urinalysis abnormalities but not as an AE, if assessed by the investigator as not clinically significant. The investigator was also to assess any increased RBC in urine as not clinically significant, if there were more likely alternatives to explain this finding. | | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Number of Participants With AEs of Special Interest: Hematuria | The number of patients diagnosed with hematuria during the main treatment period were assessed. | | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Number of Participants With AEs of Special Interest: Retroperitoneal Colicky Pain With Suspected or Confirmed Nephrolithiasis | The number of patients diagnosed with retroperitoneal colicky pain with suspected or confirmed nephrolithiasis during the main treatment period were assessed. | | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Number of Patients Treated With 30 mg/Day or 45 mg/Day IMU-838 as Compared to Placebo Who Experienced at Least One of the Following AEs: |
- Neutropenia
- Lymphopenia
- Diarrhea
- Alopecia
- Hemorrhage
- Abnormalities in alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and total bilirubin with both elevations ˃1.5 x ULN and ≥35% elevated compared to Baseline
| | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | 12-lead Electrocardiogram (ECG): Heart Rate | The 12-lead ECG was recorded in supine position after at least 5 minutes at rest using the local standard ECG machine. The ECG was analyzed qualitatively (normal or abnormal, if abnormal clinically significant [yes/no]). The heart rate, PQ-, QRS-, and QT intervals, as well as the heart rate-corrected QTc interval (according to Bazett's formula) were determined. All procedures were done according to local practice. | | Posted | | Median | Full Range | beats per minute | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | 12-lead Electrocardiogram (ECG): PQ-interval | The 12-lead ECG was recorded in supine position after at least 5 minutes at rest using the local standard ECG machine. The ECG was analyzed qualitatively (normal or abnormal, if abnormal clinically significant [yes/no]). The heart rate, PQ-, QRS-, and QT intervals, as well as the heart rate-corrected QTc interval (according to Bazett's formula) were determined. All procedures were done according to local practice. | | Posted | | Median | Full Range | msec | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | 12-lead Electrocardiogram (ECG): QRS-interval | The 12-lead ECG was recorded in supine position after at least 5 minutes at rest using the local standard ECG machine. The ECG was analyzed qualitatively (normal or abnormal, if abnormal clinically significant [yes/no]). The heart rate, PQ-, QRS-, and QT intervals, as well as the heart rate-corrected QTc interval (according to Bazett's formula) were determined. All procedures were done according to local practice. | | Posted | | Median | Full Range | msec | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | 12-lead Electrocardiogram (ECG): QT-interval | The 12-lead ECG was recorded in supine position after at least 5 minutes at rest using the local standard ECG machine. The ECG was analyzed qualitatively (normal or abnormal, if abnormal clinically significant [yes/no]). The heart rate, PQ-, QRS-, and QT intervals, as well as the heart rate-corrected QTc interval (according to Bazett's formula) were determined. All procedures were done according to local practice. | | Posted | | Median | Full Range | msec | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | 12-lead Electrocardiogram (ECG): Heart Rate-corrected QTc Interval (According to Bazett's Formula) | The 12-lead ECG was recorded in supine position after at least 5 minutes at rest using the local standard ECG machine. The ECG was analyzed qualitatively (normal or abnormal, if abnormal clinically significant [yes/no]). The heart rate, PQ-, QRS-, and QT intervals, as well as the heart rate-corrected QTc interval (according to Bazett's formula) were determined. All procedures were done according to local practice. | | Posted | | Median | Full Range | msec | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Physical Examination | Physical examinations covered the following body systems: general appearance, skin, neck (including thyroid), throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular, neurological systems, and, if applicable, others. Any new clinically significant finding compared to Screening Visit 1 had to be documented as AE. Any clinically significant finding at Screening Visit 1 had to be documented in the medical history section of the eCRF. Patients with clinically significant findings in the physical examination post Day 0 are reported. | | Posted | | Count of Participants | | Participants | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo |
|
| Secondary | Vital Signs: Height | Height in centimeters was recorded without shoes. Changes in vital signs judged by the investigator as clinically significant were to be reported as an AE. | | Posted | | Median | Full Range | cm | | at Screening | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Vital Signs: Weight (Absolute Change From Baseline at Week 24) | Weight in kilograms was recorded without shoes. Changes in vital signs judged by the investigator as clinically significant were to be reported as an AE. | Patients with observations. | Posted | | Median | Full Range | kg | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Vital Signs: Body Temperature (ºC) (Absolute Change From Baseline at Week 24) | Changes in vital signs judged by the investigator as clinically significant were to be reported as an AE. | Patients with observations. | Posted | | Median | Full Range | °C | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Vital Signs: Respiratory Rate (Absolute Change From Baseline at Week 24) | Changes in vital signs judged by the investigator as clinically significant were to be reported as an AE. | Patients with observations | Posted | | Median | Full Range | breaths/min | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Vital Signs: Pulse Rates (Absolute Change From Baseline at Week 24) | Pulse had to be measured with the patient in a seated position, after at least 5 minutes at rest. Changes in vital signs judged by the investigator as clinically significant were to be reported as an AE. | Patients with observations | Posted | | Median | Full Range | beats per minute | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Vital Signs: Systolic and Diastolic Blood Pressures (Absolute Change From Baseline at Week 24) | Blood pressure (systolic and diastolic) had to be measured with the patient in a seated position, after at least 5 minutes at rest. Changes in vital signs judged by the investigator as clinically significant were to be reported as an AE. | Patients with observations | Posted | | Median | Full Range | mmHg | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Micro Ribonucleic Acid (miR)-122 Expression | The fold change in miR-122 from pre dose to 4 hours post dose was assessed. | Patients with observations. | Posted | | Median | Full Range | fold change | | Change from Baseline to 4 hours after first dose | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Presence of John Cunningham Virus (JCV) Deoxyribonucleic Acid (DNA) in Urine in Patients With Detectable JCV-DNA in Urine | The presence of JCV-DNA in urine in patients with detectable JCV-DNA in urine at Screening Visit 1, at Week 24, and at end-of-study (EoS) was determined. | | Posted | | Count of Participants | | Participants | | At Screening Visit 1, at Week 24, and at EoS visit (EoS visit 30 days (+14 days) after last IMP intake) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
|
| Secondary | Time to Treatment Discontinuation for Any Reason | The time to treatment discontinuation up to Week 24 for any reason was determined. | Patients with observations | Posted | | Median | Full Range | days | | Up to 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Rate of Treatment Discontinuations up to Week 24 | The discontinuation rate during the main treatment period was assessed. | | Posted | | Count of Participants | | Participants | | at Week 24 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
| |
| Secondary | Population Pharmacokinetics: Minimum IMU-838 Plasma Concentration Over the Dosing Interval (Cmin) | One single measurement between 3 and 10 hours post-dose. Population pharmacokinetics have not been reported yet. | Data have not yet been analyzed. | Posted | | | | | | At Week 6 (3-10 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo. All patients received 1 tablet per day during the first 7 days of the main treatment period and then started taking 2 tablets once daily from Day 7 onwards. |
|
| Secondary | Population Pharmacokinetics: Maximum IMU-838 Plasma Concentration Over the Dosing Interval (Cmax) | One single measurement between 3 and 10 hours post-dose. Population pharmacokinetics have not been reported yet. | Data have not yet been analyzed. | Posted | | | | | | At Week 6 (3-10 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo. All patients received 1 tablet per day during the first 7 days of the main treatment period and then started taking 2 tablets once daily from Day 7 onwards. |
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| Secondary | Population Pharmacokinetics: Area Under the IMU-838 Plasma Concentration-time Curve Over the Dosing Interval (AUC0-τ) | One single measurement between 3 and 10 hours post-dose. Population pharmacokinetics have not been reported yet. | Data have not yet been analyzed. | Posted | | | | | | At Week 6 (3-10 hours post-dose) | | | | ID | Title | Description |
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| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo. All patients received 1 tablet per day during the first 7 days of the main treatment period and then started taking 2 tablets once daily from Day 7 onwards. |
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| Secondary | Population Pharmacokinetics: IMU-838 Apparent Clearance Following Oral Dosing (CL/F) | One single measurement between 3 and 10 hours post-dose. Population pharmacokinetics have not been reported yet. | Data have not yet been analyzed. | Posted | | | | | | At Week 6 (3-10 hours post-dose) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo. All patients received 1 tablet per day during the first 7 days of the main treatment period and then started taking 2 tablets once daily from Day 7 onwards. |
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| Secondary | Population Pharmacokinetics: IMU-838 Apparent Volume of Distribution (V/F) | One single measurement between 3 and 10 hours post-dose. Population pharmacokinetics have not been reported yet. | Data have not yet been analyzed. | Posted | | | | | | At Week 6 (3-10 hours post-dose) | | | | ID | Title | Description |
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| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo. All patients received 1 tablet per day during the first 7 days of the main treatment period and then started taking 2 tablets once daily from Day 7 onwards. |
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| Secondary | Plasma Trough Levels of IMU-838 | Plasma trough levels of IMU-838 were assessed at Day 7 and at Weeks 6, 12, 18, and 24. | | Posted | | Median | Full Range | μg/mL | | At Day 7 and Weeks 6, 12, 18, and 24 | | | | ID | Title | Description |
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| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
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| Secondary | Changes From Baseline in Th1 Lymphocyte Subset as Measured by Flow Cytometry | Changes from Baseline in lymphocyte subsets were listed only; no descriptive statistics by treatment arm were calculated. | Changes from Baseline in Th1 lymphocyte subsets were listed only; no descriptive statistics by treatment arm were calculated. | Posted | | | | | | At Weeks 6 and 24 (in selected Biomarker Centers only) | | | | ID | Title | Description |
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| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG002 | Placebo | |
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| Secondary | Changes From Baseline in Th17 Lymphocyte Subset as Measured by Flow Cytometry | Changes from Baseline in lymphocyte subsets were listed only; no descriptive statistics by treatment arm were calculated. | Changes from Baseline in Th17 lymphocyte subsets were listed only; no descriptive statistics by treatment arm were calculated. | Posted | | | | | | At Weeks 6 and 24 (in selected Biomarker Centers only) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG002 | Placebo | |
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| Secondary | Changes From Baseline in Treg Lymphocyte Subset as Measured by Flow Cytometry | Changes from Baseline in lymphocyte subsets were listed only; no descriptive statistics by treatment arm were calculated. | Changes from Baseline in Treg lymphocyte subsets were listed only; no descriptive statistics by treatment arm were calculated. | Posted | | | | | | At Weeks 6 and 24 (in selected Biomarker Centers only) | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG002 | Placebo | |
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| Secondary | Changes From Baseline in Serum Neurofilament | The percentage change from Baseline in serum neurofilament was calculated. | | Posted | | Median | 95% Confidence Interval | percent change | | At Week 6 and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo | During the main treatment period (24 weeks), patients received once-daily oral doses of 2 tablets of placebo with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. |
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| Secondary | Treatment Satisfaction Questionnaire for Medication (TSQM) | The TSQM is a reliable and valid instrument to assess patients' satisfaction with medication comprising 14 items across 4 domains: side effects, performance, convenience and global satisfaction. All items have 5 to 7 possible answers, except for item 4 (2 answers). Item scores for each domain are summed and transformed to a scale from 0 (extremely dissatisfied) to 100 (extremely satisfied). | | Posted | | Mean | Standard Deviation | score | | assessed at 6 weeks, 24 weeks, and end of study visit (EoS visit 30 days [+14 days] after last IMP intake), reported at Week 6 and Week 24 | | | | ID | Title | Description |
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| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (2 tablets of 15 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium, IM90838) with an initiation dosing scheme of half the dose (1 tablet per day) during the first 7 days. | | OG002 | Placebo |
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| Secondary | Difference Between 30 mg/Day IMU-838 and Placebo, 45 mg/Day IMU-838 and Placebo, and 30 mg/Day and 45 mg/Day IMU-838 for Brain Atrophy. | This endpoint was added in statistical analysis plan Version 2.0. Results of the brain atrophy analysis included biologically implausible changes (including changes of more than 1% over 24 weeks) in all treatment groups. Hence, the brain volume changes were considered technically inadequate for any conclusions of a treatment effect of IMU-838 versus placebo. | | Posted | | Mean | Standard Deviation | Percent change | | Baseline, Week 6, Week 12, Week 18, and Week 24 | | | | ID | Title | Description |
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| OG000 | IMU-838 (30 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 30 mg IMU-838 (consisting of 2 tablets of 15 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). | | OG001 | IMU-838 (45 mg/Day) | During the main treatment period (24 weeks), patients received once-daily oral doses of 45 mg IMU-838 consisting of 2 tablets of 22.5 mg vidofludimus calcium [IM90838]). All patients received half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then started taking the full assigned dose from Day 7 onwards (2 tablets once daily). |
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