Who is sponsoring NCT01097668?

NCT01097668 is sponsored by Apitope Technology (Bristol) Ltd..

What drugs are being tested in NCT01097668?

Interventions in NCT01097668: ATX-MS-1467.

What condition does NCT01097668 study?

NCT01097668 studies Relapsing Remitting Multiple Sclerosis.

Is NCT01097668 still recruiting?

NCT01097668 is currently completed. Last updated 3 February 2015.

Are results published for NCT01097668?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2015-02-03 · How we verify

NCT01097668

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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).

Completed Phase 1 Results posted Last updated 3 February 2015

What this trial tests

Phase 1 trial testing ATX-MS-1467 in Relapsing Remitting Multiple Sclerosis in 43 participants. Completed in 1 July 2013.

Timeline

1 March 2010

Primary endpoint
1 July 2013

1 July 2013

Quick facts

Lead sponsor	Apitope Technology (Bristol) Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	1 March 2010
Primary completion	1 July 2013
Estimated completion	1 July 2013
Sites	16 locations across Russia, United Kingdom

Drugs / interventions tested

ATX-MS-1467 — full drug profile →

Conditions studied

Relapsing Remitting Multiple Sclerosis — all drugs for Relapsing Remitting Multiple Sclerosis →

Sponsor

Apitope Technology (Bristol) Ltd. — full company profile →

Who can join

Adults 18 to 55, any sex, with Relapsing Remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety and Tolerability
Time frame: 48 weeks
Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Evolving understanding of autoimmune mechanisms and new therapeutic strategies of autoimmune disorders.
Song Y, Li J, Wu Y. · · 2024 · cited 109× · PMID 39362875 · DOI 10.1038/s41392-024-01952-8
Epitope-specific immunotherapy targeting CD4-positive T cells in coeliac disease: two randomised, double-blind, placebo-controlled phase 1 studies.
Goel G, King T, Daveson AJ, Andrews JM, et al · · 2017 · cited 104× · PMID 28506538 · DOI 10.1016/s2468-1253(17)30110-3
Neuroimmunotherapies Targeting T Cells: From Pathophysiology to Therapeutic Applications.
Bittner S, Wiendl H. · · 2016 · cited 24× · PMID 26563391 · DOI 10.1007/s13311-015-0405-3
Induction of Antigen-Specific Tolerance in T Cell Mediated Diseases.
Passerini L, Gregori S. · · 2020 · cited 16× · PMID 33133064 · DOI 10.3389/fimmu.2020.02194
Delivery route considerations for designing antigen-specific biomaterial strategies to combat autoimmunity.
Ackun-Farmmer MA, Jewell CM. · · 2023 · cited 15× · PMID 36938103 · DOI 10.1002/anbr.202200135

Verify or expand the search:

Other trials of ATX-MS-1467

Trials testing the same drug.

NCT01973491 — ATX-MS-1467 in Multiple Sclerosis · Phase 2 · completed

Other recruiting trials for Relapsing Remitting Multiple Sclerosis

Currently open trials in the same condition.

NCT06796504 — The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study · NA · recruiting
NCT05949580 — Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple · recruiting
NCT06282081 — Serum Neurofilament Light in Multiple Sclerosis · active not recruiting
NCT05327322 — Functional Outcomes From Diets in Multiple Sclerosis · NA · active not recruiting
NCT05171972 — Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab Treatment · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01097668 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Apitope Technology (Bristol) Ltd.
Last refreshed: 3 February 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01097668.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing