QGE031 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
162類天疱瘡(後天性表皮水疱症を含む。)4

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 90 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-003370-10-FR
(EUCTR)
24/05/201328/09/2015Safety, 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: QGE031Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;France;Taiwan;Austria;Germany
2EUCTR2012-003370-10-DE
(EUCTR)
23/01/201323/10/2012Safety, 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 AGNULLNot RecruitingFemale: yes
Male: yes
42United States;Taiwan;Austria;Germany
3NCT01688882
(ClinicalTrials.gov)
January 201317/9/2012Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid TreatmentA 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 TreatmentBullous PemphigoidDrug: QGE031;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated20 Years80 YearsAll20Phase 2United States;Austria;France;Germany;Japan;Taiwan
4EUCTR2012-003370-10-AT
(EUCTR)
13/11/201203/10/2012Safety, 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: QGE031Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
42United States;Taiwan;Austria;Germany