DDrare: Database of Drug Development for Rare Diseases

Searched query = "Pemphigus"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = ALXN1830; ARGX-113; Acetaminophen; Acetaminophen/paracetamol; Acetate; Antihistamine (cetirizine or equivalent); Azathioprine; CELLCEPT®; CORTANCYL 20 mg; Carboxymethylcellulose; CellCept 500 mg comprimidos recubiertos; CellCept®500 mg comprimidos; Cellcept® in autoimmune bullous dermatoses; Cellulose; Cetirizine; Cohort 1: 1.0 x 10^8 PolyTregs; Cohort 2: 2.5x10^8 PolyTregs; Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine; Cortancyl; Corticosteroids'therapy; Cotton; Cyclophosphamide; DSG3-CAART; Dapsone; Dermoval; Device: Carboxymethylcellulose with ionic silver (Aquacel Ag); Device: Cellulose acetate with petrolatum; Device: Cotton gauze with petrolatum; Device: Nanocrystalline silver (Acticoat); Dexamethasone; Dexamethasone (50mg 1dd6, 3 consecutive days/month); Dexamethasone 0.5mg/5ml solution; Dexamethasone 0.5mg/5ml solution in Mucolox™; EFGARTIGIMOD ALFA; Efgartigimod; Efgartigimod PH20 SC; Efgartigimod alfa; Enbrel (Etanercept); Etanercept; Filgrastim; GLYCINE; GSK1841157; General Corticotherapy; Glycine; Hematopoietic stem cell transplantation; Human interleukin-2; INCB050465; INCB050465 0.3 mg; INCB050465 0.3mg; INCB050465 1.0 mg; INCB050465 1.0mg; INCB050465 2.5mg; INCB050465 HYDROCHLORIDE; INTERLEUKIN-2; IVIg; Ianalumab; Imatinib; Infliximab; Intratect; Intratect 5%; Intravenous immunoglobulin; KC706; MABTHERA; MABTHERA®; MMF; MTX; MabThera; Mabthera; Mabthéra; Mathéra; Methotrexate; Methylprednisolone; Micofenolato mofetilo; Mycophenolate; Mycophenolate Mofetil; Mycophenolate Mofetil (MMF) 3 g/Day; Mycophenolate Mofetil 2 g/Day; Mycophenolate mofetil; OFATUMUMAB; ONO-4059; Ofatumumab; Other: Autologous Platelet rich plasma; Other: IVIg; PI-0824; PREDNISONE; PRN1008; PRN1008 (Rilzabrutinib); PRN1008 Freebase; PRN1008 Oral Tablet; Paracetamol; Parsaclisib; Petrolatum; Prednisolone; Prednisone; Prednisone/Prednisolone; RITUXIMAB; RO0452294/V02; RO1061443/F02; Rapamycin; Recombinant human interleukin-2 (rhIL-2); Rituximab; Rituximab (MABTHERA® or RITUXAN®).; Rituximab and Cyclophosphamide IV; Silver; Sirolimus; Sirolimus (formerly known as Rapamycin); TPM203; Tirabrutinib; Triamcinolone; Triamcinolone Acetonide; VAY736; WATER FOR INJECTION; Water; [NA]

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	NCT02613910 (ClinicalTrials.gov)	December 23, 2015	23/11/2015	Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris	OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris	Pemphigus	Drug: Ofatumumab;Drug: Acetaminophen /paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone /Prednisolone	GlaxoSmithKline	NULL	Terminated	N/A	N/A	All	1	Phase 3	United States
2	EUCTR2013-001370-20-PL (EUCTR)	03/07/2015	23/04/2015	Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris	OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris	Pemphigus Vulgaris MedDRA version: 19.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB	Glaxo Group Ltd	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 3	United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
3	EUCTR2013-001370-20-FR (EUCTR)	20/04/2015	13/07/2015	Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris	OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris	Pemphigus Vulgaris MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB	Glaxo Group Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	136		United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Korea, Republic of
4	EUCTR2013-001370-20-GR (EUCTR)	12/12/2014	11/12/2014	Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris	OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris	Pemphigus Vulgaris MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB	Glaxo Group Ltd	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 3	United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
5	EUCTR2013-001370-20-IT (EUCTR)	26/11/2014	25/08/2014	Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris	OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris	Pemphigus Vulgaris MedDRA version: 17.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB	Glaxo Group Ltd	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 3	United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
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
6	EUCTR2013-001370-20-HR (EUCTR)	17/11/2014	02/12/2014	Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris	OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris	Pemphigus Vulgaris MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB Product Name: ofatumumab Product Code: GSK1841157 INN or Proposed INN: OFATUMUMAB	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	136	Phase 3	United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of
7	NCT01920477 (ClinicalTrials.gov)	August 13, 2013	3/7/2013	Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris	OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris	Pemphigus Vulgaris	Biological: Ofatumumab;Biological: Placebo	Novartis Pharmaceuticals	NULL	Terminated	18 Years	70 Years	All	35	Phase 3	United States;Australia;Greece;Israel;Italy;Japan;Poland;Romania;Croatia;France;Korea, Republic of;Russian Federation;Ukraine

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

NCT02613910
(ClinicalTrials.gov)

December 23, 2015

23/11/2015

Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris

OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris

Pemphigus

Drug: Ofatumumab;Drug: Acetaminophen /paracetamol;Drug: Antihistamine (cetirizine or equivalent);Drug: Prednisone /Prednisolone

GlaxoSmithKline

NULL

Terminated

N/A

All

Phase 3

United States

EUCTR2013-001370-20-PL
(EUCTR)

03/07/2015

23/04/2015

Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris

OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris

Pemphigus Vulgaris
MedDRA version: 19.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB

Glaxo Group Ltd

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 3

United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of

EUCTR2013-001370-20-FR
(EUCTR)

20/04/2015

13/07/2015

Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris

OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris

Pemphigus Vulgaris
MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB

Glaxo Group Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

136

United States;France;Poland;Ukraine;Croatia;Australia;Russian Federation;Israel;Italy;Japan;China;Korea, Republic of

EUCTR2013-001370-20-GR
(EUCTR)

12/12/2014

11/12/2014

Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris

OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris

Pemphigus Vulgaris
MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB

Glaxo Group Ltd

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 3

United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of

EUCTR2013-001370-20-IT
(EUCTR)

26/11/2014

25/08/2014

Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris

OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris

Pemphigus Vulgaris
MedDRA version: 17.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB

Glaxo Group Ltd

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 3

United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of

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

EUCTR2013-001370-20-HR
(EUCTR)

17/11/2014

02/12/2014

Study of subcutaneous Ofatumumab Injections for Pemphigus Vulgaris

OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects with Pemphigus Vulgaris

Pemphigus Vulgaris
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
Product Name: ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

136

Phase 3

United States;Greece;Ukraine;Israel;Russian Federation;Italy;France;Poland;Croatia;Australia;China;Japan;Korea, Republic of

NCT01920477
(ClinicalTrials.gov)

August 13, 2013

3/7/2013

Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris

OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris

Pemphigus Vulgaris

Biological: Ofatumumab;Biological: Placebo

Novartis Pharmaceuticals

NULL

Terminated

18 Years

70 Years

All

Phase 3

United States;Australia;Greece;Israel;Italy;Japan;Poland;Romania;Croatia;France;Korea, Republic of;Russian Federation;Ukraine