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	NCT02383589 (ClinicalTrials.gov)	May 26, 2015	4/3/2015	A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)	A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris	Pemphigus Vulgaris	Drug: Mycophenolate Mofetil Placebo;Drug: Mycophenolate Mofetil;Drug: Rituximab;Drug: Rituximab Placebo	Hoffmann-La Roche	Genentech, Inc.	Completed	18 Years	75 Years	All	135	Phase 3	United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine
2	EUCTR2014-000382-41-FR (EUCTR)	02/04/2015	24/06/2015	A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris	A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX	Pemphigus Vulgaris (PV) 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]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 3	United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
3	EUCTR2014-000382-41-IT (EUCTR)	12/03/2015	02/02/2015	A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris	A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX	Pemphigus Vulgaris (PV) 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]	Trade Name: MABTHERA ® Product Name: Rituximab Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB Trade Name: CELLCEPT® Product Name: Mycophenolate mofetil Product Code: RO1061443/F02 INN or Proposed INN: Mycophenolate mofetil	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 3	United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
4	EUCTR2014-000382-41-ES (EUCTR)	09/03/2015	22/12/2014	A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris	A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX	Pemphigus Vulgaris (PV) 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]		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	124	Phase 3	France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
5	EUCTR2014-000382-41-DE (EUCTR)	06/03/2015	09/12/2014	A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus Vulgaris	A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX	Pemphigus Vulgaris (PV) 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]		F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	132	Phase 3	France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
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	EUCTR2004-000526-75-ES (EUCTR)	06/02/2006	12/12/2005	Estudio multicéntrico, prospectivo, aleatorizado, con doble enmascaramiento, controlado con placebo, de grupos paralelos y 52 semanas de duración para evaluar la eficacia y la seguridad del micofenolato mofetilo (MMF) como tratamiento complementario para conseguir remisión con una dosis reducida de corticosteroides en pacientes con pénfigo vulgar - Seguridad y Eficacia de micofenolato mofetilo en Pemphigus Vulgaris	Estudio multicéntrico, prospectivo, aleatorizado, con doble enmascaramiento, controlado con placebo, de grupos paralelos y 52 semanas de duración para evaluar la eficacia y la seguridad del micofenolato mofetilo (MMF) como tratamiento complementario para conseguir remisión con una dosis reducida de corticosteroides en pacientes con pénfigo vulgar - Seguridad y Eficacia de micofenolato mofetilo en Pemphigus Vulgaris	Pénfigo vulgar MedDRA version: 8.1;Level: LLT;Classification code 10052802	Trade Name: CellCept®500 mg comprimidos Product Name: CellCept 500 mg comprimidos recubiertos INN or Proposed INN: micofenolato mofetilo	Aspreva pharmaceuticals Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	72		Spain
7	NCT00683930 (ClinicalTrials.gov)	May 2004	19/5/2008	A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)	A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel Group, Mult-center, 52-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission With Reduced Corticosteroid in Subjects With Pemphigus Vulgaris	Pemphigus Vulgaris (PV)	Drug: Mycophenolate Mofetil 2 g/Day;Drug: Mycophenolate Mofetil (MMF) 3 g/Day;Drug: Placebo	Hoffmann-La Roche	Aspreva Pharmaceuticals	Completed	18 Years	70 Years	All	96	Phase 3	United States;Canada;Germany;Israel;Switzerland;Turkey;Ukraine;United Kingdom;India

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

NCT02383589
(ClinicalTrials.gov)

May 26, 2015

4/3/2015

A Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants With Pemphigus Vulgaris (PV)

A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

Pemphigus Vulgaris

Drug: Mycophenolate Mofetil Placebo;Drug: Mycophenolate Mofetil;Drug: Rituximab;Drug: Rituximab Placebo

Hoffmann-La Roche

Genentech, Inc.

Completed

18 Years

75 Years

All

135

Phase 3

United States;Argentina;Australia;Brazil;Canada;France;Germany;Israel;Italy;Spain;Turkey;Ukraine

EUCTR2014-000382-41-FR
(EUCTR)

02/04/2015

24/06/2015

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX

Pemphigus Vulgaris (PV)
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]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 3

United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy

EUCTR2014-000382-41-IT
(EUCTR)

12/03/2015

02/02/2015

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX

Pemphigus Vulgaris (PV)
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]

Trade Name: MABTHERA ®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 3

United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy

EUCTR2014-000382-41-ES
(EUCTR)

09/03/2015

22/12/2014

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX

Pemphigus Vulgaris (PV)
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]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

124

Phase 3

France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy

EUCTR2014-000382-41-DE
(EUCTR)

06/03/2015

09/12/2014

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus Vulgaris

A randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX

Pemphigus Vulgaris (PV)
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]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

132

Phase 3

France;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy

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

EUCTR2004-000526-75-ES
(EUCTR)

06/02/2006

12/12/2005

Estudio multicéntrico, prospectivo, aleatorizado, con doble enmascaramiento, controlado con placebo, de grupos paralelos y 52 semanas de duración para evaluar la eficacia y la seguridad del micofenolato mofetilo (MMF) como tratamiento complementario para conseguir remisión con una dosis reducida de corticosteroides en pacientes con pénfigo vulgar - Seguridad y Eficacia de micofenolato mofetilo en Pemphigus Vulgaris

Pénfigo vulgar
MedDRA version: 8.1;Level: LLT;Classification code 10052802

Trade Name: CellCept®500 mg comprimidos
Product Name: CellCept 500 mg comprimidos recubiertos
INN or Proposed INN: micofenolato mofetilo

Aspreva pharmaceuticals Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Spain

NCT00683930
(ClinicalTrials.gov)

May 2004

19/5/2008

A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)

A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel Group, Mult-center, 52-week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Achieve Remission With Reduced Corticosteroid in Subjects With Pemphigus Vulgaris

Pemphigus Vulgaris (PV)

Drug: Mycophenolate Mofetil 2 g/Day;Drug: Mycophenolate Mofetil (MMF) 3 g/Day;Drug: Placebo

Hoffmann-La Roche

Aspreva Pharmaceuticals

Completed

18 Years

70 Years

All

Phase 3

United States;Canada;Germany;Israel;Switzerland;Turkey;Ukraine;United Kingdom;India