GSK3196165 (Otilimab) ( DrugBank: Otilimab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ4
256筋型糖原病1

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04333147
(ClinicalTrials.gov)
May 12, 202027/3/2020Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid ArthritisArthritis, RheumatoidBiological: Otilimab (GSK3196165);Drug: csDMARD(s)GlaxoSmithKlineIqvia Pty LtdRecruiting18 YearsN/AAll3000Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hungary;India;Japan;Korea, Republic of;Latvia;Lithuania;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom
2NCT04134728
(ClinicalTrials.gov)
October 31, 201918/10/2019Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) InhibitorsA 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase InhibitorsArthritis, RheumatoidBiological: GSK3196165 (Otilimab);Biological: Sarilumab;Drug: Placebo to GSK3196165/ Sarilumab;Drug: csDMARDsGlaxoSmithKlineIqvia Pty LtdCompleted18 YearsN/AAll550Phase 3United States;Argentina;Belgium;Canada;Czechia;Germany;Hungary;Italy;Japan;Korea, Republic of;Lithuania;Poland;South Africa;Spain;United Kingdom
3NCT03970837
(ClinicalTrials.gov)
June 5, 201916/5/2019Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs)A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDsArthritis, RheumatoidBiological: GSK3196165 (Otilimab);Drug: Tofacitinib;Drug: Placebo to GSK3196165 (Otilimab);Drug: Placebo to Tofacitinib;Drug: csDMARDsGlaxoSmithKlineIqvia Pty LtdActive, not recruiting18 YearsN/AAll1764Phase 3United States;Argentina;Australia;Brazil;Bulgaria;China;Colombia;Estonia;France;Germany;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Thailand;United Kingdom
4NCT03980483
(ClinicalTrials.gov)
May 16, 201915/5/2019Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateArthritis, Rheumatoid;Glycogen Storage Disease Type IIBiological: GSK3196165 (Otilimab);Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acidGlaxoSmithKlineIqvia Pty LtdActive, not recruiting18 YearsN/AAll1537Phase 3United States;Argentina;Canada;China;Czechia;Hungary;India;Italy;Latvia;Lithuania;Malaysia;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom

256. 筋型糖原病


臨床試験数 : 180 薬物数 : 153 - (DrugBank : 30) / 標的遺伝子数 : 31 - 標的パスウェイ数 : 134
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03980483
(ClinicalTrials.gov)
May 16, 201915/5/2019Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateA 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateArthritis, Rheumatoid;Glycogen Storage Disease Type IIBiological: GSK3196165 (Otilimab);Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acidGlaxoSmithKlineIqvia Pty LtdActive, not recruiting18 YearsN/AAll1537Phase 3United States;Argentina;Canada;China;Czechia;Hungary;India;Italy;Latvia;Lithuania;Malaysia;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom