NCT01097668

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

SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Apitope Technology (Bristol) Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with relapsing forms of multiple sclerosis. This will be an open label upward dose titration involving injections on 9 occasions, each two weeks apart. After dosing is complete there will be a 22 week follow up period. Blood samples will be drawn throughout the study to monitor safety and the body's response to the injections and MRI scans will be performed on several occasions to follow the course of the multiple sclerosis during the trial.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	ATX-MS-1467	Disease specific immune modulating treatment for multiple sclerosis

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-04-02
• Last updated: 2015-02-16
• Results posted: 2015-02-16

Locations

16 sites across 2 countries: Russia, United Kingdom