Trial Outcomes & Findings for Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis (NCT NCT01517282)

Last Updated: 2014-11-21

Results Overview

The safety of multiple doses of MOR103 in patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) was assessed by evaluation of the incidence of TEAEs and TESAEs. A full listing of adverse events recorded during this trial can be found in the Adverse Events section. AEs were regarded as treatment emergent if they started on or after the first date of study drug administration or if they were present prior to the first date of study drug administration and increased in severity or relationship to study drug during the study. AEs were coded using MedDRA version 16.1

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

32 participants

Primary outcome timeframe

From the first dose (week 0) to study endpoint (week 20)

Results posted on

2014-11-21

Participant Flow

Subjects were recruited and screened between 2 January 2012 and 22 July 2013 at 5 trial centers in Europe (1 in Germany, 2 in Poland, and 2 in the United Kingdom). Screening could occur between 10 and 35 days prior to dosing on day 1. Subject eligibility was determined at the screening visit and confirmed before the first dose on day 1.

Participant milestones

Participant milestones
Measure	MOR103 0.5 mg/kg MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 2.0 mg/kg MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo Placebo administered intravenously once every 2 weeks for a total of 6 doses
Overall Study STARTED	9	8	9	6
Overall Study COMPLETED	8	7	8	5
Overall Study NOT COMPLETED	1	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	MOR103 0.5 mg/kg MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 2.0 mg/kg MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo Placebo administered intravenously once every 2 weeks for a total of 6 doses
Overall Study Consent withdrawn	0	1	1	1
Overall Study Physician Decision	1	0	0	0

Baseline Characteristics

Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=8 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 2.0 mg/kg n=9 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo n=6 Participants Placebo administered intravenously once every 2 weeks for a total of 6 doses	Total n=31 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 10.63 • n=5 Participants	48.6 years STANDARD_DEVIATION 4.98 • n=7 Participants	48.3 years STANDARD_DEVIATION 11.47 • n=5 Participants	43.5 years STANDARD_DEVIATION 15.03 • n=4 Participants	47.3 years STANDARD_DEVIATION 10.42 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	3 Participants n=4 Participants	20 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	5 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Poland	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	6 participants n=21 Participants
Region of Enrollment Germany	2 participants n=5 Participants	5 participants n=7 Participants	3 participants n=5 Participants	2 participants n=4 Participants	12 participants n=21 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	2 participants n=4 Participants	13 participants n=21 Participants
Diagnosis Relapsing-remitting multiple sclerosis	7 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	25 participants n=21 Participants
Diagnosis Secondary progressive multiple sclerosis	1 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	0 participants n=4 Participants	5 participants n=21 Participants
Diagnosis Unknown	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Time since diagnosis	5.6 years STANDARD_DEVIATION 8.68 • n=5 Participants	13.1 years STANDARD_DEVIATION 7.38 • n=7 Participants	10.7 years STANDARD_DEVIATION 8.97 • n=5 Participants	5.5 years STANDARD_DEVIATION 7.66 • n=4 Participants	9.0 years STANDARD_DEVIATION 8.51 • n=21 Participants
Gadolinium (Gd)-enhancing lesions 1 or more Gd-enhancing lesions	3 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants	10 participants n=21 Participants
Gadolinium (Gd)-enhancing lesions No Gd-enhancing lesions	5 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants	3 participants n=4 Participants	21 participants n=21 Participants

PRIMARY outcome

Timeframe: From the first dose (week 0) to study endpoint (week 20)

Population: All subjects who received 1 or more dose of placebo or MOR103 (safety population).

Outcome measures

Outcome measures
Measure	MOR103 2.0 mg/kg n=9 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo n=6 Participants Placebo administered intravenously once every 2 weeks for a total of 6 doses	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=8 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs) Any TEAE	88.9 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs) Any TEAE related to treatment	33.3 percentage of participants	83.3 percentage of participants	75.0 percentage of participants	50.0 percentage of participants
Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs) Any TEAE with MS exacerbation/relapse	0.0 percentage of participants	50.0 percentage of participants	62.5 percentage of participants	12.5 percentage of participants
Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs) Any TESAE	0 percentage of participants	16.7 percentage of participants	0 percentage of participants	12.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline, week 14, week 16, and week 20/end of study

Population: All subjects who received 1 or more dose of placebo or MOR103 (safety population). Data were missing for 1 patient each in the MOR103 1.0 mg/kg and 2.0 mg/kg groups at week 14 and week 16. Data were also missing for 1 patient in the placebo group at all post-baseline timepoints (week 14, 16, and 20).

To assess the potential immunogenicity of MOR103, a central bioanalytical laboratory (Eurofins Medinet BV, Breda, The Netherlands) tested serum samples obtained at baseline and at 3 post-treatment time points (week 14, week 16, and week 20/end of study) for anti-MOR103 antibodies.

Outcome measures

Outcome measures
Measure	MOR103 2.0 mg/kg n=9 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo n=6 Participants Placebo administered intravenously once every 2 weeks for a total of 6 doses	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=8 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples Week 14	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples Baseline	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples Week 16	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples Week 20	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Week 0 (dose 1) to week 20 (end of study)

Population: Pharmacokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data were not available for all patients at each time point.

MOR103 serum levels were measured at each visit. At all visits during the dosing period (weeks 0, 2, 6, 8, and 10), serum samples were taken before MOR103 administration (pre-dose) and 1 hour after the dose. In addition, at week 0 (first dose) and week 10 (last dose), additional samples were obtained at 2 hours and 4 hours after MOR103 administration. At visits that followed the dosing period (weeks 12, 14, 16, and 20), a single serum sample was obtained at any time during the visit.

Outcome measures

Outcome measures
Measure	MOR103 2.0 mg/kg n=8 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo Placebo administered intravenously once every 2 weeks for a total of 6 doses	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=7 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Mean Serum Concentration of MOR103 Over Time Week 8: Pre-dose	3.654 mg/L Standard Deviation 1.539	—	0.934 mg/L Standard Deviation 0.386	2.138 mg/L Standard Deviation 0.867
Mean Serum Concentration of MOR103 Over Time Week 10: Pre-dose	3.584 mg/L Standard Deviation 1.859	—	0.929 mg/L Standard Deviation 0.323	2.143 mg/L Standard Deviation 0.884
Mean Serum Concentration of MOR103 Over Time Week 20	0.118 mg/L Standard Deviation 0.034	—	0.118 mg/L Standard Deviation 0.076	0.179 mg/L Standard Deviation 0.097
Mean Serum Concentration of MOR103 Over Time Week 0: Pre-dose	0 mg/L Standard Deviation 0	—	0 mg/L Standard Deviation 0	3.778 mg/L Standard Deviation 9.995
Mean Serum Concentration of MOR103 Over Time Week 0: 1 hour after 1st dose	34.834 mg/L Standard Deviation 6.770	—	7.686 mg/L Standard Deviation 3.00	17.907 mg/L Standard Deviation 3.180
Mean Serum Concentration of MOR103 Over Time Week 0: 2 hours after 1st dose	33.600 mg/L Standard Deviation 6.336	—	7.935 mg/L Standard Deviation 1.827	17.715 mg/L Standard Deviation 3.004
Mean Serum Concentration of MOR103 Over Time Week 0: 4 hours after 1st dose	30.259 mg/L Standard Deviation 4.921	—	7.458 mg/L Standard Deviation 1.337	16.765 mg/L Standard Deviation 2.816
Mean Serum Concentration of MOR103 Over Time Week 2: Pre-dose	2.372 mg/L Standard Deviation 0.779	—	0.555 mg/L Standard Deviation 0.225	1.422 mg/L Standard Deviation 0.588
Mean Serum Concentration of MOR103 Over Time Week 2: 1 hour after 2nd dose	39.536 mg/L Standard Deviation 7.535	—	8.053 mg/L Standard Deviation 0.839	22.021 mg/L Standard Deviation 6.700
Mean Serum Concentration of MOR103 Over Time Week 4: Pre-dose	3.070 mg/L Standard Deviation 1.205	—	1.671 mg/L Standard Deviation 2.547	1.544 mg/L Standard Deviation 0.283
Mean Serum Concentration of MOR103 Over Time Week 4: 1 hour after 3rd dose	37.605 mg/L Standard Deviation 5.734	—	6.972 mg/L Standard Deviation 2.947	21.351 mg/L Standard Deviation 5.435
Mean Serum Concentration of MOR103 Over Time Week 6: Pre-dose	3.494 mg/L Standard Deviation 1.440	—	0.924 mg/L Standard Deviation 0.322	1.831 mg/L Standard Deviation 0.297
Mean Serum Concentration of MOR103 Over Time Week 6: 1 hour after 4th dose	42.200 mg/L Standard Deviation 15.467	—	9.298 mg/L Standard Deviation 1.155	21.836 mg/L Standard Deviation 6.077
Mean Serum Concentration of MOR103 Over Time Week 8: 1 hour after 5th dose	40.464 mg/L Standard Deviation 4.432	—	9.120 mg/L Standard Deviation 1.618	22.283 mg/L Standard Deviation 4.738
Mean Serum Concentration of MOR103 Over Time Week 10: 1 hour after 6th and last dose	38.853 mg/L Standard Deviation 6.720	—	8.536 mg/L Standard Deviation 1.787	23.675 mg/L Standard Deviation 7.695
Mean Serum Concentration of MOR103 Over Time Week 10: 2 hours after 6th and last dose	37.361 mg/L Standard Deviation 8.238	—	8.820 mg/L Standard Deviation 2.037	21.204 mg/L Standard Deviation 6.972
Mean Serum Concentration of MOR103 Over Time Week 10: 4 hours after 6th and last dose	35.652 mg/L Standard Deviation 6.106	—	7.942 mg/L Standard Deviation 1.105	20.960 mg/L Standard Deviation 6.521
Mean Serum Concentration of MOR103 Over Time Week 12	3.966 mg/L Standard Deviation 2.069	—	0.907 mg/L Standard Deviation 0.240	2.065 mg/L Standard Deviation 0.606
Mean Serum Concentration of MOR103 Over Time Week 14	1.318 mg/L Standard Deviation 0.419	—	0.351 mg/L Standard Deviation 0.140	0.869 mg/L Standard Deviation 0.341
Mean Serum Concentration of MOR103 Over Time Week 16	0.720 mg/L Standard Deviation 0.480	—	0.175 mg/L Standard Deviation 0.072	0.416 mg/L Standard Deviation 0.205

SECONDARY outcome

Timeframe: Week 0 (first dose) and week 10 (last dose)

Population: Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).

At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Cmax values for each patient were calculated based on these data, and the mean Cmax values for the dose cohort are presented here. Because Cmax refers to the maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable, as they represent the concentration of MOR103, but not the Cmax.

Outcome measures

Outcome measures
Measure	MOR103 2.0 mg/kg n=8 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo Placebo administered intravenously once every 2 weeks for a total of 6 doses	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=7 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses Week 10 (last dose)	40.37 mg/L Standard Deviation 6.37	—	9.03 mg/L Standard Deviation 1.81	22.53 mg/L Standard Deviation 7.71
Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses Week 0 (first dose)	35.67 mg/L Standard Deviation 6.73	—	8.60 mg/L Standard Deviation 2.08	18.70 mg/L Standard Deviation 2.97

SECONDARY outcome

Timeframe: Week 0 (first dose) and week 10 (last dose)

At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Tmax values for each patient were calculated based on these data, and the mean Tmax values for the dose cohort are presented here. Because Tmax refers to the time to maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.

Outcome measures

Outcome measures
Measure	MOR103 2.0 mg/kg n=8 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo Placebo administered intravenously once every 2 weeks for a total of 6 doses	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=7 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses Week 10 (last dose)	1.31 hour Standard Deviation 0.47	—	2.03 hour Standard Deviation 0.89	1.44 hour Standard Deviation 1.13
Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses Week 0 (first dose)	1.39 hour Standard Deviation 0.50	—	1.89 hour Standard Deviation 1.01	1.49 hour Standard Deviation 1.12

SECONDARY outcome

Timeframe: Week 0 (first dose) and week 10 (last dose)

Population: Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). Data were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).

At week 0 (first dose) and week 10 (last dose), serum samples were obtained at pre-dose and at 1, 2, 4, and 336 hours after start of dosing. To calculate the accumulation ratio, the apparent AUC calculated for the last dose was divided by the apparent AUC following the first dose using the described time points for each dosing. Because AUC is a summary outcome, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.

Outcome measures

Outcome measures
Measure	MOR103 2.0 mg/kg n=7 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo Placebo administered intravenously once every 2 weeks for a total of 6 doses	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=7 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Accumulation Ratio for Area Under the MOR103 Serum Concentration Versus Time Curve (AUC) Over One Dosing Interval: Ratio of Week 10 (Last Dose) AUC to Week 0 (First Dose) AUC	1.32 ratio of AUC values Standard Deviation 0.22	—	1.20 ratio of AUC values Standard Deviation 0.13	1.31 ratio of AUC values Standard Deviation 0.20

SECONDARY outcome

Timeframe: Week 4, week 8, week 12, and week 16.

Population: MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 4, 8, 12, and 16 were: MOR103 0.5 mg/kg: 8,8,8,8 MOR103 1.0 m/kg: 6,6,6,6 MOR103 2.0 mg/kg: 8,7,7,7 Placebo: 6, 6, 4, 5

Magnetic resonance imaging (MRI) tests were performed at screening (to confirm subject eligibility) and at Weeks 4, 8, 2, and 16. MRIs at post-screening time points were used to assess the number of new lesions as revealed by gadolinium (Gd) enhancement. Gd-enhanced MRIs reveal new brain lesions reflecting areas of active inflammation. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).

Outcome measures

Outcome measures
Measure	MOR103 2.0 mg/kg n=9 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo n=6 Participants Placebo administered intravenously once every 2 weeks for a total of 6 doses	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=8 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Number of New T1 Gadolinium-enhancing Lesions Week 4	1 Number of new T1 Gd-enhancing lesions	4 Number of new T1 Gd-enhancing lesions	8 Number of new T1 Gd-enhancing lesions	1 Number of new T1 Gd-enhancing lesions
Number of New T1 Gadolinium-enhancing Lesions Week 8	1 Number of new T1 Gd-enhancing lesions	3 Number of new T1 Gd-enhancing lesions	3 Number of new T1 Gd-enhancing lesions	2 Number of new T1 Gd-enhancing lesions
Number of New T1 Gadolinium-enhancing Lesions Week 12	1 Number of new T1 Gd-enhancing lesions	0 Number of new T1 Gd-enhancing lesions	11 Number of new T1 Gd-enhancing lesions	3 Number of new T1 Gd-enhancing lesions
Number of New T1 Gadolinium-enhancing Lesions Week 16	1 Number of new T1 Gd-enhancing lesions	3 Number of new T1 Gd-enhancing lesions	8 Number of new T1 Gd-enhancing lesions	6 Number of new T1 Gd-enhancing lesions

SECONDARY outcome

Timeframe: Week 8, week 12, and week 16.

Population: MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 8, 12, and 16 were: MOR103 0.5 mg/kg: 8,8,8 MOR103 1.0 m/kg: 6,6,6 MOR103 2.0 mg/kg: 7,7,7 Placebo: 6, 4, 5

T2-weighted magnetic resonance imaging (MRI) tests were performed at Weeks 8, 12, and 16 to assess the number of new or enlarging T2 brain lesions, a sign of MS activity. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).

Outcome measures

Outcome measures
Measure	MOR103 2.0 mg/kg n=9 Participants MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo n=6 Participants Placebo administered intravenously once every 2 weeks for a total of 6 doses	MOR103 0.5 mg/kg n=8 Participants MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=8 Participants MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Number of New or Enlarging T2 Lesions Week 16	0 Number of new or enlarging T2 lesions	5 Number of new or enlarging T2 lesions	16 Number of new or enlarging T2 lesions	9 Number of new or enlarging T2 lesions
Number of New or Enlarging T2 Lesions Week 8	2 Number of new or enlarging T2 lesions	9 Number of new or enlarging T2 lesions	23 Number of new or enlarging T2 lesions	3 Number of new or enlarging T2 lesions
Number of New or Enlarging T2 Lesions Week 12	0 Number of new or enlarging T2 lesions	1 Number of new or enlarging T2 lesions	9 Number of new or enlarging T2 lesions	3 Number of new or enlarging T2 lesions

Adverse Events

MOR103 0.5 mg/kg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

MOR103 1.0 mg/kg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

MOR103 2.0 mg/kg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Pooled Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MOR103 0.5 mg/kg n=8 participants at risk MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 1.0 mg/kg n=8 participants at risk MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	MOR103 2.0 mg/kg n=9 participants at risk MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.	Pooled Placebo n=6 participants at risk Placebo administered intravenously once every 2 weeks for a total of 6 doses
Nervous system disorders Multiple sclerosis relapse	0.00% 0/8 • From first dose of study medication to last visit (week 20) Patients were examined for adverse events (AEs) at all study visits. Data for treatment-emergent AEs (AEs occurring or worsening after the first dose of medication) are presented here.	12.5% 1/8 • From first dose of study medication to last visit (week 20) Patients were examined for adverse events (AEs) at all study visits. Data for treatment-emergent AEs (AEs occurring or worsening after the first dose of medication) are presented here.	0.00% 0/9 • From first dose of study medication to last visit (week 20) Patients were examined for adverse events (AEs) at all study visits. Data for treatment-emergent AEs (AEs occurring or worsening after the first dose of medication) are presented here.	16.7% 1/6 • From first dose of study medication to last visit (week 20) Patients were examined for adverse events (AEs) at all study visits. Data for treatment-emergent AEs (AEs occurring or worsening after the first dose of medication) are presented here.

Other adverse events

Additional Information

Roman Korolkiewicz

MorphoSys

Phone: +49 89 89927 208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All information supplied by MorphoSys is considered confidential until publication and shall not be disclosed without prior written consent from MorphoSys. No data can be published in any format without prior approval of MorphoSys, which has final decision on approving submissions for publication. In the event of disagreement in the content of a publication, both the Author's and MorphoSys' opinion will be fairly and sufficiently represented in the publication.
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