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1
53シェーグレン症候群12

49. 全身性エリテマトーデス [臨床試験数:827,薬物数:638(DrugBank:168),標的遺伝子数:108,標的パスウェイ数:191
Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 827 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-001508-12-DE
(EUCTR)
05/12/201828/08/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736
Product Code: CFZ533
INN or Proposed INN: iscalimab
Other descriptive name: CFZ533
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 2Taiwan;Thailand;Spain;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of

53. シェーグレン症候群 [臨床試験数:234,薬物数:270(DrugBank:85),標的遺伝子数:49,標的パスウェイ数:174
Searched query = "Sjogren syndrome", "Sjögren syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
12 / 234 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04541589
(ClinicalTrials.gov)
December 18, 202014/8/2020Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's SyndromeA TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's SyndromeSjögren's SyndromeDrug: CFZ533 (iscalimab);Other: CFZ533 PlaceboNovartis PharmaceuticalsNULLNot yet recruiting18 Years90 YearsAll160Phase 2NULL
2EUCTR2020-001942-20-GR
(EUCTR)
04/12/202012/10/2020Study of safety and tolerability of CFZ533 in patients with Sjögren’s SyndromeA TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: ISCALIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
3EUCTR2020-001942-20-HU
(EUCTR)
16/11/202017/09/2020Study of safety and tolerability of CFZ533 in patients with Sjögren’s SyndromeA TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: ISCALIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
4EUCTR2018-004476-35-NL
(EUCTR)
26/03/202013/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
5EUCTR2018-004476-35-SE
(EUCTR)
22/01/202002/07/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-004476-35-GB
(EUCTR)
07/01/202006/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
7EUCTR2018-004476-35-DE
(EUCTR)
22/10/201924/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
8EUCTR2018-004476-35-AT
(EUCTR)
26/09/201910/07/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
9EUCTR2018-004476-35-IT
(EUCTR)
10/09/201928/04/2020Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
10EUCTR2018-004476-35-SI
(EUCTR)
06/09/201917/09/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-004476-35-HU
(EUCTR)
07/08/201904/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
12EUCTR2018-004476-35-GR
(EUCTR)
07/08/201919/06/2019Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s SyndromeA 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS Sjögren 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: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of