97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
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
Showing 1 to 10 of 34 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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| 1 | JPRN-jRCT2031220308 | 01/11/2022 | 01/09/2022 | A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis A Study of Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Seve ... | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy with Guselkumab and Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis - DUET-UC A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Stud ... | Colitis, Ulcerative | Guselkumab Guselkumab will be administered as subcutaneous injection. Participants will receive guselkumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. Golimumab Golimumab will be administered as subcutaneous injection. Participants will receive golimumab dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (High-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 1 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Mid-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 2 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Participants who are eligible and willing to continue the study intervention that they are receiving at Week 44 may enter the long-term extension. JNJ-78934804 (Low-dose) JNJ-78934804 will be administered subcutaneously as per defined regimen. Participants will receive JNJ-78934804 dose regimen 3 SC. All participants who meet inadequate response criteria will be escalated to an active treatment. Particip Guselkumab Guselkumabwill be administered as subcutaneous injection. Participants will receive guselku ... | Nishikawa Kazuko | NULL | Pending | >= 18age old | <= 65age old | Both | 550 | Phase 2 | Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmark;Spain;Estonia;France;United Kingdom Of Great Britain;Greece;Hungary;India;Israel;Italy;Korea;Republic Of Lithuania;Mexico;Netherlands;Norway;NewZealand;Poland;Portugal;Serbia;Japan Argentina;Australia;Austria,;Belgium;Bulgaria;Brazil;Canada;Switzerland;Chile;Czechia;Germany;Denmar ... |
| 2 | JPRN-jRCT2031220186 | 10/08/2022 | 06/07/2022 | A Basket Long-term Extension Study of Ustekinumab in Pediatric Participants | A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Cl ... | Crohn Disease, Ulcerative Colitis, Psoriatic Arthritis | Participants will have continued access to ustekinumab for primary study (CNTO1275CRD1001, CNTO1275PUC3001, CNTO1275CRD3004 & CNTO1275JPA3001) participants who in the opinion of the investigator will continue to benefit from ustekinumab therapy. All blinded participants who enroll in the long-term extension (LTE) from blinded primary studies with both every 8 weeks (q8w) and every 12 weeks (q12w) dosing groups just prior to the end of the primary study will be assigned to the q8w dosing regimen. Participants enrolling in the LTE from an unblinded primary study will remain on the final dosing regimen that they were receiving in the primary study. Ustekinumab will be administered as a SC injection. Participants will have continued access to ustekinumabfor primary study (CNTO1275CRD1001, CNTO1275PU ... | Nishikawa Kazuko | NULL | Pending | >= 2age old | < 18age old | Both | 151 | Phase 3 | France;Poland;United States Of America;Japan |
| 3 | JPRN-jRCT2021220013 | 01/07/2022 | 18/06/2022 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Acti ... | A 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 A Phase 2/3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacok ... | Ulcerative Colitis (UC) | Ozanimod High Dose Ozanimod Low Dose | Liu W. Jerry | NULL | Pending | >= 2age old | <= 17age old | Both | 120 | Phase 2-3 | France;United States;Japan |
| 4 | ITMCTR2200006063 | 2022-06-05 | 2022-06-05 | A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative colitis A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative col ... | A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative colitis A systematic study on the syndrome differentiation standard of lingnan wet syndrome - ulcerative col ... | Ulcerative colitis | No intervention:No intervention;Pure western medicine intervention:Mesalazine ;Intervention of integrated Chinese and Western medicine:Mesalazine + invigorating spleen and removing dampness;Simple Chinese medicine intervention:Shenling Baizhu powder + special prescription; No intervention:No intervention;Pure western medicine intervention:Mesalazine;Intervention of integr ... | Guangdong Provincial Hospital of Chinese Medicine | NULL | Pending | 18 | 75 | Both | No intervention:25;Pure western medicine intervention:25;Intervention of integrated Chinese and Western medicine:25;Simple Chinese medicine intervention:25; | Phase 1 | China |
| 5 | ChiCTR2200059150 | 2022-05-05 | 2022-04-26 | Study on the mechanism of Qingchangxiaopi Decoction and UC large intestine damp-heat syndrome from the activation of LPDC through TLR5-IRF4 pathway to mediate intestinal inflammation Study on the mechanism of Qingchangxiaopi Decoction and UC large intestine damp-heat syndrome from t ... | Study on the mechanism of Qingchangxiaopi Decoction and UC large intestine damp-heat syndrome from the activation of LPDC through TLR5-IRF4 pathway to mediate intestinal inflammation Study on the mechanism of Qingchangxiaopi Decoction and UC large intestine damp-heat syndrome from t ... | Ulcerative colitis (UC) | Intervention group:Qingchangxiaopi Decoction;Control group:Mesalazine; | Dongguan Hospital of Guangzhou University of Chinese Medinine | NULL | Pending | 18 | 70 | Both | Intervention group:30;Control group:30; | China | |
| 6 | JPRN-jRCTs052210199 | 22/03/2022 | 22/03/2022 | Comparison of GI tract pH and motility between patients with ulcerative colitis and healthy controls Comparison of GI tract pH and motility between patients with ulcerative colitis and healthy controls ... | Comparison of total gastrointestinal pH and motility between healthy subjects and patients with ulcerative colitis using wireless motility/pH capsule Comparison of total gastrointestinal pH and motility between healthy subjects and patients with ulce ... | Ulcerative colitis | arm UC arm Health control In each case, the SmartPill motility capsule is orally taken with 50 ml of water. The temperature, pH and pressure of the entire digestive tract are measured in real time. Also, the transit time of each of the stomach, small intestine, and large intestine is calculated from the transit time of the capsule. arm UC arm Health control In each case, the SmartPill motility capsule is orally taken with 50 ml of w ... | Nakamura Shiro | Higuchi Kazuhide | Pending | >= 20age old | <= 79age old | Both | 25 | N/A | Japan |
| 7 | JPRN-jRCT2051210087 | 17/09/2021 | 22/09/2021 | Safety and pharmacokinetics study in healthy Japanese volunteers | A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple doses of ABX464 capsules in healthy Japanese volunteers. - Safety and pharmacokinetics study in healthy Japanese volunteers A Phase 1 study to assess the safety, tolerability and pharmacokinetics after single and multiple do ... | Ulcerative colitis | Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo - 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen group. Following a blinded review of available safety data by the DSMB after the subjects of the first dose regimen have received the study treatment (ABX464, 9 subjects and placebo, 3 subjects), the 50 mg dose regimen group will open for enrolment and receive the study treatment. For each dose regimen group, subjects will be admitted to the study center on D?1, administered the study treatment on D1, orally in the morning in the standardized fed conditions, and discharged from the study center on D4 after completion of study assessments. Subjects will visit the study center on D8 and D15 (End of Study [EoS] visit) for PK and safety assessments. Body weight, vital signs, laboratory parameters including renal and hepatic markers, will be evaluated at screening and at each visit to the study center. Part B Following a blinded review of available safety and PK data by the DSMB after the subjects of part A have received the study treatment (ABX464 or placebo), the part B will start for enrolment. Part B includes the following two dose regimen groups: - 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days - 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects). Enrolment will start with the 25 mg dose regimen. Part A Part A includes the following two dose regimen groups: - 25 mg dose regimen group: ABX46425 mg ... | Owada Yasuko | NULL | Pending | >= 20age old | <= 45age old | Male | 48 | Phase 1 | Japan |
| 8 | ITMCTR2100005038 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Ser ... | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Ser ... | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 9 | ChiCTR2100048502 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Ser ... | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Ser ... | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 10 | ITMCTR2100005012 | 2021-07-12 | 2021-07-04 | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen ... | A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen deficiency and dampness-blocking syndrome in remission period A randomized controlled trial of Xuyan decoction in the treatment of ulcerative colitis with spleen ... | Ulcerative colitis | Control group:Mesalazine sustained-release granules;Experimental group:Xuyan Decoction; | Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Control group:44;Experimental group:44; | China |