13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

  
14 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003625-16-HR
(EUCTR)
26/08/202012/11/2020An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple SclerosisAn Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603, TGTX1101
TG Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Belarus;Poland;Ukraine;Romania;Croatia;Russian Federation;Georgia
2NCT04130997
(ClinicalTrials.gov)
November 18, 201916/10/2019An Extension Study of Ublituximab in Participants With Relapsing Multiple SclerosisAn Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple SclerosisRelapsing Multiple Sclerosis (RMS)Biological: UblituximabTG Therapeutics, Inc.NULLEnrolling by invitation18 YearsN/AAll900Phase 3United States;Belarus;Croatia;Georgia;Poland;Russian Federation;Serbia;Ukraine
3EUCTR2017-000639-15-HR
(EUCTR)
19/12/201713/04/2018UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDY Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
TG TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Serbia;Belarus;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;Georgia;United Kingdom
4EUCTR2017-000638-75-PL
(EUCTR)
13/12/201720/09/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
TG Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Serbia;Belarus;Spain;Poland;Ukraine;Russian Federation;Georgia;United Kingdom
5EUCTR2017-000639-15-PL
(EUCTR)
06/12/201722/09/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDY Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
TG Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Belarus;Spain;Poland;Ukraine;Romania;Croatia;Russian Federation;United Kingdom
6EUCTR2017-000638-75-ES
(EUCTR)
05/12/201710/10/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
TG TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Serbia;Belarus;United States;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom
7EUCTR2017-000639-15-ES
(EUCTR)
05/12/201710/10/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDY Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
TG TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Belarus;United States;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom
8EUCTR2017-000638-75-GB
(EUCTR)
05/12/201706/09/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
TG TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3United States;Serbia;Belarus;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom
9EUCTR2017-000639-15-GB
(EUCTR)
04/12/201706/09/2017Ublituximab In Multiple Sclerosis Treatment EffectsPhase III: UbliTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - Ultimate II Study Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ubltuximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
TG TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3United States;Belarus;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom
10NCT03277261
(ClinicalTrials.gov)
August 1, 20177/9/2017A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS)UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY)Relapsing Multiple Sclerosis (RMS)Biological: Ublituximab;Drug: TeriflunomideTG Therapeutics, Inc.NULLCompleted18 Years55 YearsAll500Phase 3United States
11NCT03277248
(ClinicalTrials.gov)
August 1, 20177/9/2017A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2)ubLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY)Relapsing Multiple Sclerosis (RMS)Biological: Ublituximab;Drug: TeriflunomideTG Therapeutics, Inc.NULLCompleted18 Years55 YearsAll500Phase 3United States
12NCT03381170
(ClinicalTrials.gov)
June 1, 201718/12/2017An Extension of the TG1101-RMS201 TrialAn Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple SclerosisRelapsing Remitting Multiple SclerosisBiological: UblituximabTG Therapeutics, Inc.NULLActive, not recruiting18 Years55 YearsAll48Phase 2United States
13NCT02738775
(ClinicalTrials.gov)
March 18, 201610/4/2016Phase 2 Study of Ublituximab in Patients With Relapsing Forms of Multiple SclerosisA Placebo-Controlled Multi-Center Phase 2 Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients With Relapsing Forms of Multiple Sclerosis.Multiple SclerosisBiological: Ublituximab;Drug: PlaceboTG Therapeutics, Inc.NULLCompleted18 Years55 YearsAll48Phase 2United States
14NCT02276963
(ClinicalTrials.gov)
January 201621/10/2014Ublituximab for Acute Neuromyelitis Optica (NMO) RelapsesPhase I, Single-Center, Open Label Trial of Ublituximab + Glucocorticoids for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: UblituximabJohns Hopkins UniversityNULLCompleted18 Years100 YearsAll6Phase 1United States