Indigo ( DrugBank: Indigo )


3 diseases
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7
289クロンカイト・カナダ症候群1
300IgG4関連疾患7

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_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000037220
2020-10-012020-08-27A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitisA randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis ulcerative colitisTraditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules;Shuguang Hospital affiliated to Shanghai University of traditional Chinese MedicineNULLRecruitingBothTraditional Chinese medicine group:40;Western medicine group:40;China
2ITMCTR2000003772
2020-10-012020-08-27A randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitisA randomized controlled clinical trial of Qingdai(indigo naturalis) in the treatment of mild to moderate active ulcerative colitis ulcerative colitisTraditional Chinese medicine group:Qingdai (indigo naturalis);Western medicine group:Mesalazine granules;Shuguang Hospital affiliated to Shanghai University of traditional Chinese MedicineNULLRecruitingBothTraditional Chinese medicine group:40;Western medicine group:40;China
3JPRN-jRCTs031190156
09/12/201909/12/2019IN for practical useStudy on efficacy and safety of indigo naturalis in patients with intractable ulcerative colitis. ulcertive colitisadministration of one indigo naturalis FC enteric-coated tablet (including 0.5g indigo naturalis per tablet)twice a day for 4 weeksKanai TakanoriNULLRecruiting>= 16age oldNot applicableBoth100Phase 3Japan
4JPRN-UMIN000029633
2017/12/2720/10/2017The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis.The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis. - The efficacy of indigo naturalis-containing suppository in patients with active ulcerative colitis. ulcerative colitisadministration of the suppository ,which contains 0.05g indigo naturalis, for 4 weeksKeio University School of MedicineNULLComplete: follow-up complete18years-oldNot applicableMale and Female10Not selectedJapan
5JPRN-jRCTs071180073
08/08/201722/03/2019Further maintenance of remission for a year after Qing-Dai withdrawal in ulcerative colitis treatment:randomized controlled trialFurther maintenance of remission for a year after Qing-Dai withdrawal in ulcerative colitis treatment:randomized controlled trial - None Ulcerative colitis
Ulcerative colitis
arm A :stop oral administration of indigo naturalis
arm B :continue oral administration of indigo naturalis
Kitazono TakanariNULLComplete>= 16age oldNot applicableBoth40Phase 2Japan
6JPRN-UMIN000021460
2015/10/2013/03/2016Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer.Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer. - Chromoendoscopy of colitic cancer using an acetic acid indigocarmine mixture patients with ulcerative colitis had high risk of colitic cancer.A:patients suspected dysplasia(low/high grade) or cancer.B:patients had plan of treatment of the dysplasia or cancer.40mL AIM solution (0.6% acetic acid with 0.4% IC) was sprinkled onto the lesions and images were recorded.Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesNULLComplete: follow-up complete20years-old80years-oldMale and Female30Not selectedJapan
7JPRN-UMIN000017359
2015/05/0701/05/2015Investigation of the safety of Indigo naturalis for the patients with ulcerative colitisInvestigation of the safety of Indigo naturalis for the patients with ulcerative colitis - Investigation of the safety of Indigo naturalis for the patients with ulcerative colitis ulcerative colitisOral administration of Indigo naturalis
2g/day, 4 weeks
Osaka University, Graduate School of Medicine, Department of Gastroenterology and HepatologyNULLRecruiting20years-old95years-oldMale and Female20Not selectedJapan

289. クロンカイト・カナダ症候群


臨床試験数 : 1 薬物数 : 1 - (DrugBank : 1) / 標的遺伝子数 : 0 - 標的パスウェイ数 : 0
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000025246
2016/12/1313/12/2016Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome.Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome. - Safety and efficacy of indigo naturalis for chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndrome. chronic enteropathy associated with SLCO2A1 and Cronkhite-Canada syndromeindigo naturalis 2g/day for oral administration is be administered daily in 2 divided doses during 8weeks.Keio University Gastroenterology and HepatologyNULLComplete: follow-up complete20years-old69years-oldMale and Female6Not selectedJapan

300. IgG4関連疾患


臨床試験数 : 40 薬物数 : 47 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05662241
(ClinicalTrials.gov)
September 30, 202214/12/2022A Phase 3 Study of Obexelimab in Patients With IgG4-Related DiseaseA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With IgG4-Related Disease (INDIGO)IgG4 Related DiseaseDrug: Obexelimab;Other: PlaceboZenas BioPharma (USA), LLCNULLRecruiting18 YearsN/AAll200Phase 3United States
2JPRN-jRCTs051210171
07/02/202207/02/2022The treatment using indigo naturalis for autoimmune pancreatitisSafety of indigo naturalis in patients with autoimmune pancreatitis - Indigo naturalis for autoimmune pancreatitis Autoimmune pancreatitis
Autoimmune pancreatitis
Administration of indigo naturalisKamata KenNULLRecruiting>= 20age oldNot applicableBoth10Phase 2Japan
3EUCTR2017-002214-31-NL
(EUCTR)
23/07/201909/08/2018Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) IgG4-Related Disease
MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: XmAb5871
INN or Proposed INN: XmAb5871
Other descriptive name: XMAB5871
Xencor, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Netherlands;Germany;Sweden
4EUCTR2017-002214-31-IT
(EUCTR)
26/02/201904/11/2020Study to Evaluate the Safety and Effectiveness of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO)Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) - INDIGO IgG4-Related Disease
MedDRA version: 21.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: NA
Product Code: [XmAb5871]
Xencor INCNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden
5EUCTR2017-002214-31-BE
(EUCTR)
22/10/2018Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) IgG4-Related Disease
MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: XmAb5871
INN or Proposed INN: XmAb5871
Other descriptive name: XMAB5871
Xencor, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden
6EUCTR2017-002214-31-GB
(EUCTR)
03/08/2018Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) IgG4-Related Disease
MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: XmAb5871
INN or Proposed INN: XmAb5871
Other descriptive name: XMAB5871
Xencor, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden;United States;Spain;Israel;United Kingdom
7EUCTR2017-002214-31-SE
(EUCTR)
17/10/2018Study to Evaluate The Safety And Effectiveness of XmAb®5871 In Patients With IgG4-Related Disease (INDIGO)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of XmAb®5871 in Patients with IgG4-Related Disease (INDIGO) IgG4-Related Disease
MedDRA version: 20.0;Level: LLT;Classification code 10071581;Term: IgG4 related sclerosing disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: XmAb5871
INN or Proposed INN: XmAb5871
Other descriptive name: XMAB5871
Xencor, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Netherlands;Sweden