96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209

  
10 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1JPRN-jRCT2031200406
27/03/202110/03/2021A Study of JNJ-64304500 as Add-on Therapy in Participants with Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET Crohn DiseaseGroup 1- Standard of Care (SOC) Biological Therapy: Adalimumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo subcutaneous (SC) injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to adalimumab or its biosimilar as SOC therapy.

Group 2: SOC Biological Therapy: Ustekinumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo SC injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to ustekinumab as SOC therapy.
Numaguchi HirotakaNULLNot Recruiting>= 18age old<= 65age oldBoth70Phase 2Canada;France;Germany;Italy;Spain;United States Of America;Japan
2NCT04655807
(ClinicalTrials.gov)
March 3, 202130/11/2020A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-64304500;Drug: Placebo;Drug: Adalimumab;Drug: UstekinumabJanssen Research & Development, LLCNULLWithdrawn18 Years65 YearsAll0Phase 2United States;Canada;France;Germany;Italy;Japan;Spain;Sweden
3EUCTR2020-002701-26-IT
(EUCTR)
12/01/202107/04/2021A clinical study to evaluate the safety and effectiveness of JNJ-64304500 as an add-on therapy to standard of care biologic therapy with anti-tumor necrosis factor alpha or anti-interleukin 12/23 in responder not remitter participants with active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: JNJ-64304500
Product Code: [JNJ-64304500]
INN or Proposed INN: JNJ-64304500
Other descriptive name: sezione * D.3.6.2.1 - valore: 400mg alla settimana 0, in seguito 200mg ogni due settimane
JANSSEN CILAG INTERNATIONAL NVNULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;United States;Canada;Spain;Germany;Japan;Italy;Sweden
4EUCTR2016-000634-21-FR
(EUCTR)
28/01/201908/11/2018A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
693Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
5EUCTR2016-000634-21-PL
(EUCTR)
13/01/201711/10/2016A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
654Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Korea, Republic of
6EUCTR2016-000634-21-IT
(EUCTR)
29/12/201622/01/2021A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn¿s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn¿s Disease - - Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: -
Product Code: JNJ-64304500
INN or Proposed INN: -
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA¿
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: -
JANSSEN CILAG INTERNATIONAL NVNULLNot RecruitingFemale: yes
Male: yes
654Phase 2United States;Korea, Democratic People's Republic of;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Korea, Republic of
7EUCTR2016-000634-21-HU
(EUCTR)
11/11/201612/09/2016A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
693Phase 2United States;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
8EUCTR2016-000634-21-GB
(EUCTR)
11/11/201603/08/2016 A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
654 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
9EUCTR2016-000634-21-DE
(EUCTR)
08/11/201607/07/2016A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
INN or Proposed INN: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
654Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
10NCT02877134
(ClinicalTrials.gov)
August 25, 201619/8/2016A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's DiseaseA Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-64304500;Drug: Placebo;Drug: UstekinumabJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll388Phase 2United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Czechia;Italy;Serbia