Stelara 130mg / 26mL concentrate for solution for ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
96クローン病1

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004527-16-IT
(EUCTR)
21/12/202129/09/2021A study to test whether BI 706321 combined with ustekinumab helps people with Crohn’s DiseaseA Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment - InCharge Crohn`s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Stelara 130mg / 26mL concentrate for solution for infusion
Product Name: Stelara 130mg / 26mL concentrate for solution for infusion
Product Code: [Stelara 130mg / 26mL concentrate for solution for
INN or Proposed INN: USTEKINUMAB
Product Name: BI 706321
Product Code: [BI 706321]
Product Name: BI 706321
Product Code: [BI 706321]
Product Name: BI 706321
Product Code: [BI 706321]
Trade Name: STELARA - 90 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) 1 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 1 ML
Product Name: Stelara 90mg/1ml solution for injection in pre-filled syringe (PFS)
Product Code: [Stelara 90mg/1ml solution for injecti
BOEHRINGER INGELHEIM INTERNATIONAL GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2France;United States;Czechia;Spain;Poland;Belgium;Italy