Vobarilizumab ( DrugBank: Vobarilizumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス3

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-000372-95-DE
(EUCTR)
08/10/201517/06/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
2EUCTR2015-000372-95-HU
(EUCTR)
24/09/201530/06/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Hungary;Czech Republic;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
3EUCTR2015-000372-95-CZ
(EUCTR)
20/08/201516/06/2015Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus ErythematosusA Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000017968;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody
Ablynx N.V.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of