DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
13	多発性硬化症／視神経脊髄炎	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-002180-33-PL (EUCTR)	16/11/2016	14/07/2016	Multiple sclerosis therapy with transdermal myelin peptide stimulation.	Multiple sclerosis therapy with transdermal myelin peptide stimulation.	relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: Avonex INN or Proposed INN: Interferon beta 1-A Other descriptive name: INTERFERON BETA-1A	Centrum Neurologii Krzysztof Selmaj	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220	Phase 2	Poland
2	NCT02427776 (ClinicalTrials.gov)	January 2015	2/4/2015	A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis	A Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimulated and Expanded ex Vivo by a Myelin Oligodendrocyte Glycoprotein Peptide Modified by the Introduction of a Thioreductase Motif Into the Flanking Residues of the Cell Epitope - A First-in-human Trial (SCLEROLYM TRIAL)	Multiple Sclerosis, Relapsing-Remitting	Biological: Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope	Imcyse SA	NULL	Terminated	18 Years	50 Years	All	2	Phase 1;Phase 2	Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-002180-33-PL
(EUCTR)

16/11/2016

14/07/2016

Multiple sclerosis therapy with transdermal myelin peptide stimulation.

relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: SMderpept
INN or Proposed INN: PLP peptide
INN or Proposed INN: MBP peptide
INN or Proposed INN: MOG peptide
Product Name: SMderpept
INN or Proposed INN: PLP peptide
INN or Proposed INN: MBP peptide
INN or Proposed INN: MOG peptide
Product Name: Avonex
INN or Proposed INN: Interferon beta 1-A
Other descriptive name: INTERFERON BETA-1A

Centrum Neurologii Krzysztof Selmaj

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 2

Poland

NCT02427776
(ClinicalTrials.gov)

January 2015

2/4/2015

A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis

A Clinical Trial to Document Safety and Radiological Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis Treated With Autologous CD4+ T Cells, Stimulated and Expanded ex Vivo by a Myelin Oligodendrocyte Glycoprotein Peptide Modified by the Introduction of a Thioreductase Motif Into the Flanking Residues of the Cell Epitope - A First-in-human Trial (SCLEROLYM TRIAL)

Multiple Sclerosis, Relapsing-Remitting

Biological: Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope

Imcyse SA

NULL

Terminated

18 Years

50 Years

All

Phase 1;Phase 2

Belgium