CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 43 enrolled
Drug / intervention
ATX-MS-1467biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01097668
NCT01097668Phase 1Completed
CompareCT.gov

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).

Apitope Technology (Bristol) Ltd.·interventional·Posted Apr 2, 2010·Updated Feb 16, 2015

In Brief

A Phase 1 clinical trial evaluating ATX-MS-1467 for Relapsing Remitting Multiple Sclerosis. Completed, enrolled 43 participants across 16 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Remitting Multiple Sclerosis
CountriesRussia, United Kingdom
CollaboratorsAptiv Solutions, ClinStar, LLC

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2010
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.3 years ago

Interventions

ATX-MS-1467biological

Disease specific immune modulating treatment for multiple sclerosis