DDrare: Database of Drug Development for Rare Diseases

Searched query = "Pemphigoid", "Epidermolysis bullosa acquisita"
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 = 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE; AC-203 1% Topical Ointment; AKST4290; ARAVA; Acetate; Apremilast; Avdoralimab; Avdoralimab (IPH5401); Azathioprine; Azathioprine or Mycophenolate mofetil; BIV009; Benralizumab; Bertilimumab; Blood test; CC; CC-10004; CORTANCYL 20 mg; Carboxymethylcellulose; Cellcept® in autoimmune bullous dermatoses; Cellulose; Clobetasol; Clobetasol 0.05% Topical Ointment; Clobetasol Propionate cream treatment; Clobetasol propionate; Clobetasol propionate + Methotrexate; Clobetasol propionate alone; Collagenase; Cortancyl; Cotton; Cultivated oral mucosal epithelial sheet transplantation; Cyclophosphamide; Cyclophosphamide 50Mg Oral Tablet; Cyclosporine; DERMOVAL; DF2156A; DUPILUMAB; Data report; Dermoval; Device: Carboxymethylcellulose with ionic silver (Aquacel Ag); Device: Cellulose acetate with petrolatum; Device: Cotton gauze with petrolatum; Device: Nanocrystalline silver (Acticoat); Dexamethasone; Dexamethasone 0.5mg/5ml solution; Dexamethasone 0.5mg/5ml solution in Mucolox™; Doxycycline; Dupilumab; Dupixent; Gold; Halometasone; INTERLEUKIN-2; IPH5401; Imatinib; Infliximab; Ixekizumab; Ladarixin; Leflunomide; MABTHERA; MTX; MabThera; Mabthera; Mabthéra; Mathéra; Medrone; Mepolizumab; Mepolizumab (a-IL-5 antibody); Methotrexate; Methylprednisolone; Minocycline; Mometasone; Mometasone furoate; Mycophenolate; Mycophenolate mofetil; Myfortic; Myfortic 180 mg; Myfortic 180 mg Filmtabletten; NNC0215-0384; NPB-01; Nicotinamide; Omalizumab; Oral corticosteroids (OCS); Otezla; Other: Blood sample and cotton skin swabs; Other: Control; PREDNISONE; Petrolatum; Prednisolone; Prednisone; Procedure: Clobetasol propionate; Procedure: Impedance analysis; Procedure: bone densitometry; Procedure: collagenase; Procedure: radiographs of the thoracic and lumbar spine; QGE031; RESTASIS; RITUXIMAB; RVA576; Riboflavin; Rituximab; Rituximab 1g IV; Rituximab combined with Omalizumab; SIMVASTATIN; Silver; Simvastatin; Simvastatin-ratiopharm; Simvastatin-ratiopharm®; Solu-Medrone; Tildrakizumab; Tildrakizumab Prefilled Syringe; Topical infliximab; Treatment systemic therapy (prednisone); Treatment with systemic therapy (doxycycline); Treatment with systemic therapy (methotrexate); Treatment with systemic therapy (prednisone); Treatment with topical superpotent corticosteroid therapy; Tripterygium; Ustekinumab

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	EUCTR2012-003370-10-FR (EUCTR)	24/05/2013	28/09/2015	Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.	A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment	refractory bullous pemphigoid MedDRA version: 18.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: QGE031	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	42	Phase 2	United States;France;Taiwan;Austria;Germany
2	EUCTR2012-003370-10-DE (EUCTR)	23/01/2013	23/10/2012	Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.	A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment	Refractory Bullous Pemphigoid MedDRA version: 16.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: QGE031 INN or Proposed INN: QGE031	Novartis Pharma Services AG	NULL	Not Recruiting			Female: yes Male: yes	42		United States;Taiwan;Austria;Germany
3	NCT01688882 (ClinicalTrials.gov)	January 2013	17/9/2012	Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment	A Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Bullous Pemphigoid With Disease Refractory to Oral Steroid Treatment	Bullous Pemphigoid	Drug: QGE031;Drug: Placebo	Novartis Pharmaceuticals	NULL	Terminated	20 Years	80 Years	All	20	Phase 2	United States;Austria;France;Germany;Japan;Taiwan
4	EUCTR2012-003370-10-AT (EUCTR)	13/11/2012	03/10/2012	Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.	A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment	Refractory Bullous Pemphigoid MedDRA version: 15.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: QGE031	Novartis Pharma AG	NULL	Not Recruiting			Female: yes Male: yes	42		United States;Taiwan;Austria;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

EUCTR2012-003370-10-FR
(EUCTR)

24/05/2013

28/09/2015

Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.

A randomized, double-blind, placebo controlled, parallel group study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of QGE031 in the treatment of patients with bullous pemphigoid with disease refractory to oral steroid treatment

refractory bullous pemphigoid
MedDRA version: 18.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: QGE031

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;France;Taiwan;Austria;Germany

EUCTR2012-003370-10-DE
(EUCTR)

23/01/2013

23/10/2012

Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.

Refractory Bullous Pemphigoid
MedDRA version: 16.1;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: QGE031
INN or Proposed INN: QGE031

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

United States;Taiwan;Austria;Germany

NCT01688882
(ClinicalTrials.gov)

January 2013

17/9/2012

Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment

A Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of QGE031 in the Treatment of Patients With Bullous Pemphigoid With Disease Refractory to Oral Steroid Treatment

Bullous Pemphigoid

Drug: QGE031;Drug: Placebo

Novartis Pharmaceuticals

NULL

Terminated

20 Years

80 Years

All

Phase 2

United States;Austria;France;Germany;Japan;Taiwan

EUCTR2012-003370-10-AT
(EUCTR)

13/11/2012

03/10/2012

Safety, efficacy and PK/PD of QGE031 vs. placebo in patients with active bullous phemphigoid despite oral steroid treatment.

Refractory Bullous Pemphigoid
MedDRA version: 15.0;Level: LLT;Classification code 10006567;Term: Bullous pemphigoid;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: QGE031

Novartis Pharma AG

NULL

Not Recruiting

Female: yes
Male: yes

United States;Taiwan;Austria;Germany