ISCALIMAB ( DrugBank: Iscalimab )

2 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
49	全身性エリテマトーデス	4
53	シェーグレン症候群	21

49. 全身性エリテマトーデス

臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-001508-12-FR (EUCTR)	05/02/2019	13/11/2018	Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SL ...	A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess p ...	Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: ...	Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 ...	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Austr ...
2	EUCTR2018-001508-12-ES (EUCTR)	12/12/2018	09/10/2018	Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SL ...	A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess p ...	Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: ...	Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 ...	Novartis Farmacéutica, S.A.	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	120	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ...	Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Austr ...
3	EUCTR2018-001508-12-DE (EUCTR)	05/12/2018	28/08/2018	Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SL ...	A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess ph ...	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: ...	Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 ...	Novartis Pharma AG	NULL	Not Recruiting	Female: yes Male: yes	135	Phase 2	United States;Czechia;Taiwan;Spain;Thailand;Israel;Russian Federation;France;Czech Republic;Hungary; ...
4	EUCTR2018-001508-12-CZ (EUCTR)	02/11/2018	28/08/2018	Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SL ...	A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess ph ...	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: ...	Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 ...	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	135	Phase 2	Argentina;Russian Federation;Hungary;Japan;Thailand;Spain;Czech Republic;China;Taiwan;Korea, Republi ...

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53. シェーグレン症候群

臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188

diseases per page:

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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
1	EUCTR2020-001942-20-SE (EUCTR)	20/04/2022	02/03/2022	Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose l ...	Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrom ...	Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Unite ...
2	EUCTR2020-001942-20-NL (EUCTR)	26/10/2021	10/05/2021	Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose l ...	Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrom ...	Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Unite ...
3	EUCTR2020-001942-20-IT (EUCTR)	14/04/2021	04/06/2021	Study of safety and tolerability of CFZ533 in patients with Sjögren's Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose l ...	Sjögren’s Syndrome. MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's synd ...	Product Name: iscalimab Product Code: [CFZ533] INN or Proposed INN: ISCALIMAB	NOVARTIS PHARMA AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Unite ...
4	EUCTR2020-001942-20-PT (EUCTR)	31/03/2021	10/11/2020	Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose l ...	Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrom ...	Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Unite ...
5	EUCTR2020-001942-20-DE (EUCTR)	09/02/2021	29/10/2020	Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose l ...	Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrom ...	Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Unite ...
6	JPRN-jRCT2071200072	07/01/2021	21/12/2020	Study of Safety and Tolerability of CFZ533 in Patients With Sjogren's Syndrome (TWINSS Extn)	A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose L ...	Sjogren's Syndrome Sjogren's Syndrome, autoimmune, ESSDAI, ESSPRI, anti-CD40, CFZ533, iscalimab, TWI ...	Arm 1 - Iscalimab Dose 1 Arm 2 - Iscalimab Dose 2 and Placebo	Yamada Hiroyuki	NULL	Recruiting	>= 18age old	<= 90age old	Both	16	Phase 2	Australia;Hungary;Japan
7	NCT04541589 (ClinicalTrials.gov)	January 5, 2021	14/8/2020	Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's Syndrome	A TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose L ...	Sjögren's Syndrome	Drug: CFZ533 (iscalimab);Other: CFZ533 Placebo	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	90 Years	All	214	Phase 2	United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;France;Germany;Greece;Hungary ...
8	EUCTR2020-001942-20-GR (EUCTR)	04/12/2020	12/10/2020	Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose l ...	Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrom ...	Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;Unite ...
9	EUCTR2020-001942-20-HU (EUCTR)	16/11/2020	17/09/2020	Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome	A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose l ...	Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrom ...	Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	160	Phase 2	Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of;United States;Slovenia;Greece; ...
10	EUCTR2018-004476-35-RO (EUCTR)	11/08/2020	27/04/2022	Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients wit ...	A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safet ...	Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrom ...	Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 2	Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;Unite ...

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