Clinical Trial Results:
An Open-label, One-arm, Proof of Concept Trial to Evaluate the Safety of ATX-MS-1467 (MSC2358825A) and its Effect on Immune Tolerance in Subjects with Relapsing Multiple Sclerosis
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Summary
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EudraCT number |
2013-002916-28 |
Trial protocol |
LV |
Global end of trial date |
11 Apr 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Mar 2017
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First version publication date |
17 Mar 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
EMR200166-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01973491 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Merck KGaA
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Sponsor organisation address |
Frankfurter Strasse 250, Darmstadt, Germany, 64293
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Public contact |
Communication Center Merck KGaA, Merck KGaA, +49 615172 5200 , service@merckgroup.com
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Scientific contact |
Communication Center Merck KGaA, Merck KGaA, +49 615172 5200 , service@merckgroup.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Apr 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
11 Apr 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Apr 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the trial is to evaluate the effects of ATX-MS-1467 administered intradermally, titrated to a dose of 800 microgram (mcg) every 2 weeks (biweekly), for a total period of 20 weeks on 1.5T MRI parameters compared to a Baseline Control Period off treatment in subjects with relapsing Multiple Sclerosis.
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Protection of trial subjects |
Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Feb 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
2 Months | ||
Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Latvia: 1
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Country: Number of subjects enrolled |
Russian Federation: 36
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Worldwide total number of subjects |
37
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EEA total number of subjects |
1
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
37
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
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Pre-assignment
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Screening details |
37 subjects were enrolled in the study and entered the 8-week Baseline Control Period. Following completion of the Baseline Control Period, eligible subjects entered the 4-week Titration Period followed by a 16-week Treatment Period. | ||||||||||||
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Period 1
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Period 1 title |
Baseline Control Period (8 Weeks)
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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ATX-MS-1467 | ||||||||||||
Arm description |
Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period. | ||||||||||||
Arm type |
No intervention | ||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Period 2
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Period 2 title |
Titration Period (4 Weeks)
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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ATX-MS-1467 | ||||||||||||
Arm description |
Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
ATX-MS-1467
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
Subjects received intradermal injection of ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period.
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Period 3
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Period 3 title |
Treatment Period (16 Weeks)
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Is this the baseline period? |
Yes [1] | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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ATX-MS-1467 | ||||||||||||
Arm description |
Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
ATX-MS-1467
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intradermal use
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Dosage and administration details |
Subjects received biweekly intradermal injection of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
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| Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: All analysis in the study were carried out for the subjects who received the study drug during the Treatment Period. |
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| Notes [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Baseline Characteristics were to be presented for the subjects who received study treatment. Therefore, out of 37 subjects enrolled in the study, 19 subjects who received treatment were included in the Baseline Characteristics section. |
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Baseline characteristics reporting groups
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Reporting group title |
Treatment Period (16 Weeks)
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Reporting group description |
Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period. The Safety (SAF) Analysis Set included all subjects who received at least 1 dose of investigational medicinal product (IMP). | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
ATX-MS-1467
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Reporting group description |
Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period. | ||
Reporting group title |
ATX-MS-1467
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Reporting group description |
Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period. | ||
Reporting group title |
ATX-MS-1467
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Reporting group description |
Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period. | ||
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End point title |
Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans [1] | ||||||||||||
End point description |
T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported. The modified intention-to-treat (mITT) analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.
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End point type |
Primary
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End point timeframe |
Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only descriptive statistics were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) | ||||||||||||||||||||
End point description |
The number of T1 CELs were measured using MRI scans. mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP. Here, "n" signifies those subjects who were evaluable at the specified time point.
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End point type |
Secondary
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End point timeframe |
Weeks 12, 16, 20, 24, 28 and 36
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36 | ||||||||||||||||||||
End point description |
T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0). mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP. Here, "n " signifies those subjects who were evaluable at the specified time point.
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End point type |
Secondary
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End point timeframe |
Baseline (Weeks -8, -4 and 0), Weeks 12, 16, 20, 24, 28 and 36
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36 | ||||||||||||||||||||||
End point description |
T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0). mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP. Here, "n" signifies those subjects who were evaluable at the specified time point.
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End point type |
Secondary
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End point timeframe |
Baseline (Weeks -8, -4, 0), Weeks 12, 16, 20, 24, 28 and 36
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions | ||||||||||||||||||||
End point description |
T2 lesions were measured using MRI scans. mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP. Here, "n" signifies those subjects who were evaluable at the specified time point.
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End point type |
Secondary
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End point timeframe |
Weeks 12, 16, 20, 24, 28 and 36
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36 | ||||||||||||||||||||||
End point description |
T1 CELs were measured using MRI scans. mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP. Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure and "n" signifies those subjects who were evaluable at the specified time point.
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End point type |
Secondary
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End point timeframe |
Week 0, 12, 16, 20, 24, 28 and 36
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36 | ||||||||||||||||||||||
End point description |
T1 CELs were measured using MRI scans. mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP. Here, "Number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure and "n" signifies those subjects who were evaluable at the specified time point.
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End point type |
Secondary
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End point timeframe |
Weeks 0, 12, 16, 20, 24, 28 and 36
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| No statistical analyses for this end point | |||||||||||||||||||||||
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End point title |
Mean Annualized Relapse Rate | ||||||||
End point description |
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period). Analysis population included subset of mITT analysis set who had relapse.
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End point type |
Secondary
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End point timeframe |
Week 20
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to First Relapse | ||||||||
End point description |
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The miTT analysis set was evaluable. Here, "99999" indicated data not available as very few subjects had relapse during the study.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 36
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Total Expanded Disability Status Scale (EDSS) Score at Week 20 | ||||||||||||
End point description |
EDSS is an ordinal scale in half-point increments that qualifies disability in subjects with Multiple Sclerosis. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as any other neurological findings due to Multiple Sclerosis. Total EDSS score ranges from 0 (normal neurological examination) to 10 (death due to MS). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0). mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP. Here, "n" signifies those subjects who were evaluable at the specified time point.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 20
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Total Multiple Sclerosis Functional Composite (MSFC) Score at Week 20 | ||||||||||||
End point description |
The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0). The mITT analysis set was evaluable. Here, "n" signifies those subjects who were eva
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End point type |
Secondary
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End point timeframe |
Baseline (Week 0) and Week 20
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation | ||||||||||||||
End point description |
An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent adverse events are defined as any AE with a start date on or after the date of first dose and within 28 days after the date of last dose in the current study. TEAEs include both Serious TEAEs and non-serious TEAEs.Safety Set.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 25
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Number of Subjects Experiencing Injection Site Reactions (ISRs) | ||||||
End point description |
Treatment-emergent ISRs were defined as any ISR with a start date on or after the date of first dose and within 7 days after the date of last dose in the current study. Injection site reactions were identified as erythema, induration, pruritus, nodules and/or cysts, ecchymosis, pain and local edema. The SAF Analysis Set included all subjects who received at least 1 dose of IMP.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 22
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline up to Week 25
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
ATX-MS-1467
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Reporting group description |
Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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06 May 2014 |
1) Removed the requirement for purified protein derivative skin test at Visit 1 (Screening) as part of the inclusion criteria.
2) Clarified the timeframe between the optional lumbar puncture at Visit 4 and Visit 5, and timing of Visit 15 lumbar puncture.
3) Deleted the laboratory parameter "cholinesterase". |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
