Ravagalimab ( DrugBank: Ravagalimab )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
53シェーグレン症候群1
97潰瘍性大腸炎7

53. シェーグレン症候群


臨床試験数 : 283 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-003131-31-NL
(EUCTR)
05/02/202012/12/2019Ravagalimab Vs Placebo in Subjects with Moderately to Severely Active Primary Sjogren's SyndromeA Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects with Moderately to Severely Active Primary Sjogren’s Syndrome. Moderately to Severely Active Primary Sjogren's Syndrome
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ravagalimab
Product Code: ABBV-323
INN or Proposed INN: Ravagalimab
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Netherlands

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 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
1EUCTR2018-000930-37-HU
(EUCTR)
17/08/202024/06/2020A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyA Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ravagalimab
Product Code: ABBV-323
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;France;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
2EUCTR2018-000930-37-ES
(EUCTR)
27/05/201922/01/2019A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyA Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ABBV-323
INN or Proposed INN: RAVAGALIMAB
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
3EUCTR2018-000930-37-DE
(EUCTR)
24/04/201918/10/2018A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyA Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ravagalimab
Product Code: ABBV-323
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;United States;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
4EUCTR2018-000930-37-IT
(EUCTR)
19/04/201914/06/2021A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyA Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy - NA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ravagalimab
Product Code: [ABBV-323]
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;United States;Hungary;Canada;Spain;Netherlands;Germany;United Kingdom;Italy;Korea, Republic of
5NCT03695185
(ClinicalTrials.gov)
March 26, 20192/10/2018A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyA Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyUlcerative Colitis (UC)Drug: ABBV-323 Dose A;Drug: ABBV-323 Dose BAbbVieNULLCompleted18 Years75 YearsAll42Phase 2United States;Canada;France;Germany;Hungary;Italy;Korea, Republic of;Netherlands;Spain;United Kingdom
6EUCTR2018-000930-37-GB
(EUCTR)
03/01/201901/11/2018A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyA Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ravagalimab
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2United States;France;Hungary;Canada;Spain;Netherlands;Germany;Italy;United Kingdom;Korea, Republic of
7EUCTR2018-000930-37-NL
(EUCTR)
21/12/201811/10/2018A Study to Investigate safety and how well Ravagalimab (ABBV-323) works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior TherapyA Multicenter, Single-Arm, Open-Label Study to Investigate the Efficacy and Safety of Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Ravagalimab
Product Code: ABBV-323
INN or Proposed INN: Not assigned
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;United States;Hungary;Canada;Spain;Germany;Netherlands;United Kingdom;Italy;Korea, Republic of