Secukinumab 150 mg/1 mL Solution for injection ( DrugBank: Secukinumab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
37膿疱性乾癬(汎発型)1
271強直性脊椎炎1

37. 膿疱性乾癬(汎発型)


臨床試験数 : 74 薬物数 : 53 - (DrugBank : 20) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 101
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-003086-34-BE
(EUCTR)
10/02/201409/12/2013Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects with Moderate to Severe Chronic Palmoplantar Pustular PsoriasisA 52-week, multicenter, randomized, double-blind, placebo-controlledstudy of subcutaneous secukinumab to demonstrate efficacy as assessedby palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI) at16 weeks of treatment, compared to placebo, and to assess long-termsafety, tolerability, and efficacy in subjects with moderate to severechronic palmoplantar pustular psoriasis - amended with an optionalextension treatment period of up to a total of 148 weeks moderate to severe chronic palmoplantar pustular psoriasis
MedDRA version: 20.0;Level: PT;Classification code 10037575;Term: Pustular psoriasis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Level: LLT;Classification code 10037158;Term: Psoriasis palm & soles;System Organ Class: 100000018190;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Secukinumab 150 mg/1 mL Solution for injection
Product Code: AIN457
INN or Proposed INN: SECUKINUMAB
Other descriptive name: SECUKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3France;Poland;Spain;Belgium;Austria;Russian Federation;Germany;Italy;United Kingdom;Sweden

271. 強直性脊椎炎


臨床試験数 : 563 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-001089-40-BE
(EUCTR)
23/01/201402/12/20133-year follow-up study of secukinumab treatment in patients with active Ankylosing SpondylitisAn extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis Ankylosing spondylitis
MedDRA version: 18.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab 150 mg/1 ml Solution for injection
Product Name: Secukinumab
Product Code: AIN457
INN or Proposed INN: Secukinumab 75 mg/0.5 ml Solution for injection
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Taiwan;Turkey;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Belgium;Peru;Bulgaria;Germany;Netherlands