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_ gender	Target_ size	Phase	Countries
1	EUCTR2018-002261-19-HR (EUCTR)	22/08/2019	20/11/2019	A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus	pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: PRN1008 (Rilzabrutinib) Product Code: PRN1008 INN or Proposed INN: not available Other descriptive name: PRN1008	Principia Biopharma	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	120	Phase 3	United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany
2	EUCTR2018-002261-19-DE (EUCTR)	17/05/2019	10/12/2018	A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus	pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: PRN1008 (Rilzabrutinib) Product Code: PRN1008 INN or Proposed INN: not available Other descriptive name: PRN1008	Principia Biopharma	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	120	Phase 3	United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany
3	EUCTR2018-002261-19-GB (EUCTR)	02/04/2019	17/01/2019	A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus	pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: PRN1008 (Rilzabrutinib) Product Code: PRN1008 INN or Proposed INN: not available Other descriptive name: PRN1008	Principia Biopharma	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	120	Phase 3	Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany
4	EUCTR2018-002261-19-BG (EUCTR)	12/12/2018	11/10/2018	A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus	pemphigus vulgaris [PV] or pemphigus foliaceus [PF] MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Product Name: PRN1008 (Rilzabrutinib) Product Code: PRN1008 INN or Proposed INN: not available Other descriptive name: PRN1008	Principia Biopharma	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	120	Phase 3	Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany

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

EUCTR2018-002261-19-HR
(EUCTR)

22/08/2019

20/11/2019

A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus

pemphigus vulgaris [PV] or pemphigus foliaceus [PF]
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858
MedDRA version: 21.0;Classification code 10057054;Term: Pemphigus foliaceous;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Product Name: PRN1008 (Rilzabrutinib)
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008

Principia Biopharma

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 3

United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany

EUCTR2018-002261-19-DE
(EUCTR)

17/05/2019

10/12/2018

A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus

Product Name: PRN1008 (Rilzabrutinib)
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008

Principia Biopharma

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 3

United States;Serbia;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Croatia;Australia;Bulgaria;Germany

EUCTR2018-002261-19-GB
(EUCTR)

02/04/2019

17/01/2019

A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus

Product Name: PRN1008 (Rilzabrutinib)
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008

Principia Biopharma

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 3

Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany

EUCTR2018-002261-19-BG
(EUCTR)

12/12/2018

11/10/2018

A study to evaluate the efficacy and safety of PRN1008 in patients with pemphigus

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Oral BTK Inhibitor PRN1008 in Moderate to Severe Pemphigus

Product Name: PRN1008 (Rilzabrutinib)
Product Code: PRN1008
INN or Proposed INN: not available
Other descriptive name: PRN1008

Principia Biopharma

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 3

Serbia;United Arab Emirates;United States;Taiwan;Greece;Spain;Ukraine;Turkey;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Croatia;Australia;Bulgaria;Germany