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Phase Ib Study to Evaluate MOR103 in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01517282
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : October 13, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Biological: MOR103
Other: Placebo
Enrollment 32
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Hide Arm/Group Description MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses. MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. Placebo administered intravenously once every 2 weeks for a total of 6 doses
Period Title: Overall Study
Started 9 [1] 8 9 [2] 6
Completed 8 7 8 5
Not Completed 1 1 1 1
Reason Not Completed
Consent withdrawn             0             1             1             1
Physician Decision             1             0             0             0
[1]
One patient was randomized but did not receive study medication based on the investigator's decision
[2]
1 patient completed the trial, but received only 4 doses of medication and 2 MRIs due to pregnancy
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo Total
Hide Arm/Group Description MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses. MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. Placebo administered intravenously once every 2 weeks for a total of 6 doses Total of all reporting groups
Overall Number of Baseline Participants 8 8 9 6 31
Hide Baseline Analysis Population Description
All subjects who received 1 or more dose of placebo or MOR103 (safety population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 9 participants 6 participants 31 participants
47.8  (10.63) 48.6  (4.98) 48.3  (11.47) 43.5  (15.03) 47.3  (10.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 6 participants 31 participants
Female
4
  50.0%
6
  75.0%
7
  77.8%
3
  50.0%
20
  64.5%
Male
4
  50.0%
2
  25.0%
2
  22.2%
3
  50.0%
11
  35.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 6 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
White
7
  87.5%
8
 100.0%
9
 100.0%
5
  83.3%
29
  93.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 6 participants 31 participants
Poland 2 1 1 2 6
Germany 2 5 3 2 12
United Kingdom 4 2 5 2 13
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 6 participants 31 participants
Relapsing-remitting multiple sclerosis 7 6 6 6 25
Secondary progressive multiple sclerosis 1 1 3 0 5
Unknown 0 1 0 0 1
Time since diagnosis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 9 participants 6 participants 31 participants
5.6  (8.68) 13.1  (7.38) 10.7  (8.97) 5.5  (7.66) 9.0  (8.51)
Gadolinium (Gd)-enhancing lesions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 9 participants 6 participants 31 participants
1 or more Gd-enhancing lesions 3 3 1 3 10
No Gd-enhancing lesions 5 5 8 3 21
1.Primary Outcome
Title Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs)
Hide Description 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
Time Frame From the first dose (week 0) to study endpoint (week 20)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received 1 or more dose of placebo or MOR103 (safety population).
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Hide Arm/Group Description:
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Placebo administered intravenously once every 2 weeks for a total of 6 doses
Overall Number of Participants Analyzed 8 8 9 6
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 100 100 88.9 100
Any TEAE related to treatment 75.0 50.0 33.3 83.3
Any TEAE with MS exacerbation/relapse 62.5 12.5 0.0 50.0
Any TESAE 0 12.5 0 16.7
2.Secondary Outcome
Title Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples
Hide Description 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.
Time Frame Baseline, week 14, week 16, and week 20/end of study
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Hide Arm/Group Description:
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Placebo administered intravenously once every 2 weeks for a total of 6 doses
Overall Number of Participants Analyzed 8 8 9 6
Measure Type: Number
Unit of Measure: percentage of participants
Baseline 100 100 100 100
Week 14 100 100 100 100
Week 16 100 100 100 100
Week 20 100 100 100 100
3.Secondary Outcome
Title Mean Serum Concentration of MOR103 Over Time
Hide Description 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.
Time Frame Week 0 (dose 1) to week 20 (end of study)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg
Hide Arm/Group Description:
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Overall Number of Participants Analyzed 8 7 8
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 0: Pre-dose 0  (0) 3.778  (9.995) 0  (0)
Week 0: 1 hour after 1st dose 7.686  (3.00) 17.907  (3.180) 34.834  (6.770)
Week 0: 2 hours after 1st dose 7.935  (1.827) 17.715  (3.004) 33.600  (6.336)
Week 0: 4 hours after 1st dose 7.458  (1.337) 16.765  (2.816) 30.259  (4.921)
Week 2: Pre-dose 0.555  (0.225) 1.422  (0.588) 2.372  (0.779)
Week 2: 1 hour after 2nd dose 8.053  (0.839) 22.021  (6.700) 39.536  (7.535)
Week 4: Pre-dose 1.671  (2.547) 1.544  (0.283) 3.070  (1.205)
Week 4: 1 hour after 3rd dose 6.972  (2.947) 21.351  (5.435) 37.605  (5.734)
Week 6: Pre-dose 0.924  (0.322) 1.831  (0.297) 3.494  (1.440)
Week 6: 1 hour after 4th dose 9.298  (1.155) 21.836  (6.077) 42.200  (15.467)
Week 8: Pre-dose 0.934  (0.386) 2.138  (0.867) 3.654  (1.539)
Week 8: 1 hour after 5th dose 9.120  (1.618) 22.283  (4.738) 40.464  (4.432)
Week 10: Pre-dose 0.929  (0.323) 2.143  (0.884) 3.584  (1.859)
Week 10: 1 hour after 6th and last dose 8.536  (1.787) 23.675  (7.695) 38.853  (6.720)
Week 10: 2 hours after 6th and last dose 8.820  (2.037) 21.204  (6.972) 37.361  (8.238)
Week 10: 4 hours after 6th and last dose 7.942  (1.105) 20.960  (6.521) 35.652  (6.106)
Week 12 0.907  (0.240) 2.065  (0.606) 3.966  (2.069)
Week 14 0.351  (0.140) 0.869  (0.341) 1.318  (0.419)
Week 16 0.175  (0.072) 0.416  (0.205) 0.720  (0.480)
Week 20 0.118  (0.076) 0.179  (0.097) 0.118  (0.034)
4.Secondary Outcome
Title Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses
Hide Description 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.
Time Frame Week 0 (first dose) and week 10 (last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg
Hide Arm/Group Description:
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Overall Number of Participants Analyzed 8 7 8
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 0 (first dose) 8.60  (2.08) 18.70  (2.97) 35.67  (6.73)
Week 10 (last dose) 9.03  (1.81) 22.53  (7.71) 40.37  (6.37)
5.Secondary Outcome
Title Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses
Hide Description 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.
Time Frame Week 0 (first dose) and week 10 (last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg
Hide Arm/Group Description:
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Overall Number of Participants Analyzed 8 7 8
Mean (Standard Deviation)
Unit of Measure: hour
Week 0 (first dose) 1.89  (1.01) 1.49  (1.12) 1.39  (0.50)
Week 10 (last dose) 2.03  (0.89) 1.44  (1.13) 1.31  (0.47)
6.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Week 0 (first dose) and week 10 (last dose)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg
Hide Arm/Group Description:
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Overall Number of Participants Analyzed 8 7 7
Mean (Standard Deviation)
Unit of Measure: ratio of AUC values
1.20  (0.13) 1.31  (0.20) 1.32  (0.22)
7.Secondary Outcome
Title Number of New T1 Gadolinium-enhancing Lesions
Hide Description 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).
Time Frame Week 4, week 8, week 12, and week 16.
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Hide Arm/Group Description:
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Placebo administered intravenously once every 2 weeks for a total of 6 doses
Overall Number of Participants Analyzed 8 8 9 6
Measure Type: Number
Unit of Measure: Number of new T1 Gd-enhancing lesions
Week 4 8 1 1 4
Week 8 3 2 1 3
Week 12 11 3 1 0
Week 16 8 6 1 3
8.Secondary Outcome
Title Number of New or Enlarging T2 Lesions
Hide Description 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).
Time Frame Week 8, week 12, and week 16.
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Hide Arm/Group Description:
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
Placebo administered intravenously once every 2 weeks for a total of 6 doses
Overall Number of Participants Analyzed 8 8 9 6
Measure Type: Number
Unit of Measure: Number of new or enlarging T2 lesions
Week 8 23 3 2 9
Week 12 9 3 0 1
Week 16 16 9 0 5
Time Frame From first dose of study medication to last visit (week 20)
Adverse Event Reporting Description 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.
 
Arm/Group Title MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Hide Arm/Group Description MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses. MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. Placebo administered intravenously once every 2 weeks for a total of 6 doses
All-Cause Mortality
MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   1/8 (12.50%)   0/9 (0.00%)   1/6 (16.67%) 
Nervous system disorders         
Multiple sclerosis relapse  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MOR103 0.5 mg/kg MOR103 1.0 mg/kg MOR103 2.0 mg/kg Pooled Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   8/8 (100.00%)   8/9 (88.89%)   6/6 (100.00%) 
Ear and labyrinth disorders         
Vertigo  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Eye disorders         
Cataract  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Eye pain  1  1/8 (12.50%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Vision blurred  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Visual acuity reduced  1  3/8 (37.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Visual impairment  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Constipation  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Diarrhea  1  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  0/6 (0.00%) 
Gingival bleeding  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Nausea  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Oesophageal pain  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Toothache  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
General disorders         
Asthenia  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Chest discomfort  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Fatigue  1  2/8 (25.00%)  0/8 (0.00%)  1/9 (11.11%)  2/6 (33.33%) 
Feeling hot  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Feeling of body temperature change  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Gait disturbance  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Influenza-like illness  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Injection site pain  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Oedema peripheral  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  2/6 (33.33%) 
Infections and infestations         
Cystitis  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Gastroenteritis  1  0/8 (0.00%)  0/8 (0.00%)  2/9 (22.22%)  0/6 (0.00%) 
Herpes simplex  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Lower respiratory tract infection  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Nasopharyngitis  1  4/8 (50.00%)  3/8 (37.50%)  1/9 (11.11%)  4/6 (66.67%) 
Oral herpes  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Rhinitis  1  0/8 (0.00%)  2/8 (25.00%)  0/9 (0.00%)  0/6 (0.00%) 
Sinusitis  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Urinary tract infection  1  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  1/6 (16.67%) 
Viral infection  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications         
Arthropod bite  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Fall  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Urethral injury  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Investigations         
Aspartate aminotransferase increased  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Blood cholesterol increased  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Blood creatinine phosphokinase increased  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Blood potassium increased  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
C-reactive protein increased  1  0/8 (0.00%)  1/8 (12.50%)  1/9 (11.11%)  0/6 (0.00%) 
Carbon monoxide diffusing capacity decreased  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Hemoglobin urine present  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Hysteroscopy  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Lymphocyte count decreased  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Lymphocyte count increased  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Nuclear magnetic resonance imaging abnormal  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Peak expiratory flow rate decreased  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Red blood cells urine positive  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
White blood cell count decreased  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
White blood cell count increased  1  1/8 (12.50%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/8 (12.50%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Back pain  1  3/8 (37.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Joint swelling  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Muscle contracture  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Muscle spasms  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Muscle twitching  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Musculoskeletal stiffness  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Pain in extremity  1  1/8 (12.50%)  1/8 (12.50%)  1/9 (11.11%)  0/6 (0.00%) 
Nervous system disorders         
Balance disorder  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Cerebellar syndrome  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Decreased vibratory sense  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  1/6 (16.67%) 
Dizziness  1  0/8 (0.00%)  1/8 (12.50%)  0/9 (0.00%)  0/6 (0.00%) 
Headache  1  1/8 (12.50%)  3/8 (37.50%)  1/9 (11.11%)  2/6 (33.33%) 
Migraine  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Multiple sclerosis relapse  1  4/8 (50.00%)  1/8 (12.50%)  0/9 (0.00%)  3/6 (50.00%) 
Paresthesia  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  2/6 (33.33%) 
Sciatica  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Sensory disturbance  1  3/8 (37.50%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Sinus headache  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Somnolence  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Pregnancy, puerperium and perinatal conditions         
Pregnancy  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Psychiatric disorders         
Depression  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Insomnia  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Mental disorder due to a general medical condition  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Renal and urinary disorders         
Dysuria  1  0/8 (0.00%)  0/8 (0.00%)  1/9 (11.11%)  0/6 (0.00%) 
Pollakiuria  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Reproductive system and breast disorders         
Menopausal symptoms  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Postmenopausal hemorrhage  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Vaginal discharge  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/8 (0.00%)  2/8 (25.00%)  0/9 (0.00%)  0/6 (0.00%) 
Dyspnea  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Oropharyngeal pain  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Rhinalgia  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Sinus congestion  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders         
Blister  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Surgical and medical procedures         
Intra-uterine contraceptive device  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Intra-uterine contraceptive device removal  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Vascular disorders         
Hypertension  1  0/8 (0.00%)  0/8 (0.00%)  0/9 (0.00%)  1/6 (16.67%) 
Phlebitis  1  1/8 (12.50%)  0/8 (0.00%)  0/9 (0.00%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Key limitations of this trial include its small sample size and limited duration. Efficacy assessments were not made in this study. Larger clinical trials will be required to evaluate the potential of MOR103 in treating patients with MS.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roman Korolkiewicz
Organization: MorphoSys
Phone: +49 89 89927 208
EMail: roman.korolkiewicz@morphosys.com
Layout table for additonal information
Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT01517282    
Other Study ID Numbers: 2011-001064-22
First Submitted: January 10, 2012
First Posted: January 25, 2012
Results First Submitted: October 8, 2014
Results First Posted: October 13, 2014
Last Update Posted: November 21, 2014