SB012 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎2

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-004599-36-DE
(EUCTR)
23/04/201403/02/2014SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once dailySB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE Active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Product Name: SB012
INN or Proposed INN: hgd40
sterna biologicals GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
2NCT02129439
(ClinicalTrials.gov)
April 201430/4/2014Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis PatientsSB012 for Treatment of Active Ulcerative Colitis: Prospective Multi-centre Randomised Double-blind Placebo-controlled Phase IIa Clinical Trial to Evaluate Efficacy, Pharmacokinetics, Tolerability and Safety of SB012 Enema Administered ODColitis, UlcerativeDrug: SB012;Drug: PlaceboSterna Biologicals GmbH & Co. KGNULLCompleted18 Years75 YearsAll20Phase 1/Phase 2Germany