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

This study has been completed.

Sponsor:

Collaborators:

Aptiv Solutions

ClinStar, LLC

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

History of Changes

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 ]

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If the Investigator drafts a publication, he/she agrees to send it to Apitope for review and comment before its submission to the journal. If Apitope considers that the proposed publication contains patentable material or information which should be protected as valuable confidential information, Apitope reserves the right to delay submission to the journal until patent applications have been filed and/or require the deletion of the confidential information from the proposed publication.

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

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

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