ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborators:
Aptiv Solutions
ClinStar Europe LLC (Russia)
Information provided by (Responsible Party):
Apitope Technology (Bristol) Ltd.
ClinicalTrials.gov Identifier:
NCT01097668
First received: March 31, 2010
Last updated: February 3, 2015
Last verified: February 2015
Results First Received: December 23, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Biological: ATX-MS-1467

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Screening and study procedures were performed at hospital clinics within the United Kingdom and Russian Federation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were human lymphocyte antigen (HLA)-DRB1*15 positive with relapsing-remitting multiple sclerosis as defined by the McDonald criteria and as assessed by a neurologist.

Reporting Groups
  Description
Intradermal Injection Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
Subcutaneous Injection Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.

Participant Flow:   Overall Study
    Intradermal Injection     Subcutaneous Injection  
STARTED     21     22  
Week 20     21 [1]   22 [1]
Week 48     19     20  
COMPLETED     19     20  
NOT COMPLETED     2     2  
Withdrawal by Subject                 1                 2  
Lost to Follow-up                 1                 0  
[1] Patient evaluability time point = week 20



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
>=18 and <=55 years Gender, female and male

Reporting Groups
  Description
Intradermal Injection Injections of ATX-MS-1467 given by the intradermal route
Subcutaneous Injection Injections of ATX-MS-1467 given by the subcutaneous route
Total Total of all reporting groups

Baseline Measures
    Intradermal Injection     Subcutaneous Injection     Total  
Number of Participants  
[units: participants]
  21     22     43  
Age  
[units: years]
Mean ( Full Range )
  33.0  
  ( 22 to 53 )  
  31.6  
  ( 18 to 52 )  
  32.3  
  ( 18 to 53 )  
Gender  
[units: participants]
     
Female     17     13     30  
Male     4     9     13  
Region of Enrollment  
[units: participants]
     
Russian Federation     14     20     34  
United Kingdom     7     2     9  



  Outcome Measures
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1.  Primary:   Safety and Tolerability   [ Time Frame: 48 weeks ]

2.  Secondary:   The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).   [ Time Frame: 16 and 20 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chief Executive Officer
Organization: Apitope Technology (Bristol) Ltd
phone: +44(0)117 3707720
e-mail: keith.martin@apitope.com


No publications provided


Responsible Party: Apitope Technology (Bristol) Ltd.
ClinicalTrials.gov Identifier: NCT01097668     History of Changes
Other Study ID Numbers: ATX-MS-1467-002
Study First Received: March 31, 2010
Results First Received: December 23, 2014
Last Updated: February 3, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russian Republic: Ministry of Health and Social Development of the Russian Federation