Low dose ( 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15

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT04314375
(ClinicalTrials.gov)
March 202317/3/2020Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative ColitisA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: PlaceboBausch Health Americas, Inc.NULLNot yet recruiting5 Years17 YearsAll70Phase 4NULL
2JPRN-jRCT2021220013
01/07/202218/06/2022A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative ColitisA Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis with an Inadequate Response to Conventional Therapy Ulcerative Colitis (UC)Ozanimod High Dose
Ozanimod Low Dose
Liu W. JerryNULLPending>= 2age old<= 17age oldBoth120Phase 2-3France;United States;Japan
3JPRN-jRCT2011210030
11/01/202230/08/2021Phase 2 Dose-finding UC StudyA 54-Week, Multicenter, Randomized, Double-blind, Placebocontrolled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Expedition Lead-in Ulcerative Colitis, Colitis, Ulcerative, IBD- Brazikumab low dose: IV brazikumab 720 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10

- Brazikumab high-dose: IV brazikumab 1440 mg at Week 0 (Day 1), Week 2, and Week 6 followed by SC brazikumab 120 mg or 240 mg every 4 weeks beginning at Week 10

- Placebo: IV placebo at Week 0 (Day 1), Week 2, and Week 6 followed by SC placebo every 4 weeks beginning at Week 10
Ageishi YujiNULLRecruiting>= 18age old<= 80age oldBoth21Phase 2Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;United States;Japan
4JPRN-jRCT2071210030
19/10/202131/05/2021A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative ColitisA Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy Colitis, UlcerativeInduction Period: Participants >=30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >=30 kg were included in this arm.

Induction Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of >15 to <30 kg were included in this arm.

Induction Period: Participants 10 to 15 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period. Participants with UC having Baseline weight of 10 to 15 kg were included in this arm.

Maintenance Period: Participants >=30 kg, Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.

Maintenance Period: Participants >=30 kg, Vedolizumab 150 mg
Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >=30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.

Maintenance Period: Participants >15 to <30 kg, Vedolizumab 200 mg
Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.

Maintenance Period: Participants >15 to <30 kg, Vedolizumab 100 mg
Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Wee
Shikamura MitsuhiroNULLRecruiting>= 2age old<= 17age oldBoth120Phase 3United States;Belgium;Bosnia;Croatia;Australia;Canada;Czech Republic;Germany;Hungary;Italy;Lithuania;Poland;New Zealand;Romania;Russia;Slovakia;Spain;United Kingdom;Israel;China;Ukraine;Japan
5NCT04857112
(ClinicalTrials.gov)
September 29, 202119/4/2021Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative ColitisA Phase 2, Randomized, Double-Blinded, Placebo Controlled, Parallel Group Study Evaluating the Efficacy and Safety of Amiselimod (MT-1303) in Subjects With Mild to Moderate Ulcerative Colitis (UC)Ulcerative ColitisDrug: Low Dose MT-1303;Drug: High Dose MT-1303;Drug: PlaceboBausch Health Americas, Inc.NULLRecruiting18 Years75 YearsAll336Phase 2United States
6JPRN-JapicCTI-163356
29/9/201623/08/2016I6T-MC-AMACA Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis Ulcerative ColitisIntervention name : LY3074828
INN of the intervention : mirikizumab
Dosage And administration of the intervention : Induction:High, Mid or Low dose LY3074828. Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:LY3074828 dose schedule1 or 2.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Induction:Placebo Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:Placebo
Eli Lilly Japan K.K.NULLcomplete1875BOTH30Phase 2Japan, North America, Europe, Oceania
7NCT02493712
(ClinicalTrials.gov)
January 20167/7/2015A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-MA Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative ColitisColitis, UlcerativeDrug: High dose;Drug: Low dose;Drug: PlaceboHoly Stone Healthcare Co., LtdinVentiv Health ClinicalCompleted18 Years75 YearsAll51Phase 2Italy;Taiwan
8NCT02200445
(ClinicalTrials.gov)
February 201522/7/2014Low Dose IL-2 for Ulcerative ColitisA Phase I Study of Low Dose Subcutaneous Interleukin-2 (IL-2) For The Treatment of Ulcerative Colitis.Ulcerative ColitisDrug: Interleukin-2 (aldesleukin).Scott SnapperNULLCompleted18 Years70 YearsAll26Phase 1United States
9NCT02093663
(ClinicalTrials.gov)
December 12, 201417/3/2014Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative ColitisA Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance PhasesUlcerative ColitisDrug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose)ShireNULLCompleted5 Years17 YearsAll107Phase 3United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands
10NCT01988506
(ClinicalTrials.gov)
January 6, 20147/11/2013Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory DiseasesInduction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic ApproachRheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic SclerosisDrug: Interleukin 2Assistance Publique - Hôpitaux de ParisIltoo PharmaCompleted18 YearsN/AAll81Phase 2France
11NCT01959165
(ClinicalTrials.gov)
November 21, 20138/10/2013MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis PatientsUlcerative ColitisDrug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching PlaceboAstraZenecaNULLCompleted18 Years65 YearsAll44Phase 2Japan
12NCT01810185
(ClinicalTrials.gov)
March 201311/3/2013Low Dose Naltrexone in Symptomatic Inflammatory Bowel DiseaseLow Dose Naltrexone in Symptomatic Inflammatory Bowel DiseaseInflammatory Bowel Disease;Crohn's Disease;Ulcerative ColitisDrug: Low dose naltrexone;Drug: PlaceboSanta Barbara Cottage HospitalNULLWithdrawn18 YearsN/ABoth0Phase 2United States
13NCT01697670
(ClinicalTrials.gov)
September 201228/9/2012Photodynamic Therapy for Ulcerative ColitisA Multicenter, Open Phase II Study to Assess the Effect and Safety of Low Dose Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative ColitisUlcerative ColitisDrug: Photodynamic therapy with GliolanUniversity of ZurichSwiss National Science FoundationRecruiting18 YearsN/ABoth7Phase 1Switzerland
14NCT01240915
(ClinicalTrials.gov)
February 201110/11/2010A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative ColitisA Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative ColitisColitis, UlcerativeDrug: placebo;Drug: MultiStem low dose;Drug: MultiStem high dosePfizerAthersys, IncCompleted18 YearsN/AAll105Phase 2United States;Belgium;Canada;Germany;Hungary;Italy;Slovakia;Sweden
15NCT00659802
(ClinicalTrials.gov)
February 7, 20088/4/2008Phase II Study of HMPL-004 in Patients With Ulcerative ColitisA Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without MesalamineUlcerative ColitisDrug: HMPL-004 low dose;Drug: Placebo;Drug: HMPL-004 high doseHutchison Medipharma LimitedNULLCompleted18 YearsN/AAll224Phase 2United States