53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details


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

  
21 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2020-001942-20-SE
(EUCTR)
20/04/202202/03/2022Study 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 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
2EUCTR2020-001942-20-NL
(EUCTR)
26/10/202110/05/2021Study 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-IT
(EUCTR)
14/04/202104/06/2021Study 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 - Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome Sjögren’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: iscalimab
Product Code: [CFZ533]
INN or Proposed INN: ISCALIMAB
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 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
4EUCTR2020-001942-20-PT
(EUCTR)
31/03/202110/11/2020Study 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 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
5EUCTR2020-001942-20-DE
(EUCTR)
09/02/202129/10/2020Study 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 2Portugal;United States;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
6JPRN-jRCT2071200072
07/01/202121/12/2020Study 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 Levels Administered Subcutaneously in Patients With Sjogren's Syndrome Sjogren's Syndrome
Sjogren's Syndrome, autoimmune, ESSDAI, ESSPRI, anti-CD40, CFZ533, iscalimab, TWINSS Extension
Arm 1 - Iscalimab Dose 1
Arm 2 - Iscalimab Dose 2 and Placebo
Yamada HiroyukiNULLRecruiting>= 18age old<= 90age oldBoth16Phase 2Australia;Hungary;Japan
7NCT04541589
(ClinicalTrials.gov)
January 5, 202114/8/2020Study 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 PharmaceuticalsNULLRecruiting18 Years90 YearsAll214Phase 2United States;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Russian Federation;Sweden;Turkey;United Kingdom
8EUCTR2020-001942-20-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
9EUCTR2020-001942-20-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 2Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Portugal
10EUCTR2018-004476-35-RO
(EUCTR)
11/08/202027/04/2022Study 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
11EUCTR2018-004476-35-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 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of
12EUCTR2018-004476-35-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 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;Korea, Republic of;Sweden
13EUCTR2018-004476-35-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
14EUCTR2018-004476-35-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;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
15EUCTR2018-004476-35-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
16EUCTR2018-004476-35-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
17EUCTR2018-004476-35-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 AGNULLNot RecruitingFemale: yes
Male: yes
260Phase 2Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of;United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France
18EUCTR2018-004476-35-PT
(EUCTR)
19/08/201923/05/2019Study 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: 20.0;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 finished Female: yes
Male: yes
260 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;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
19EUCTR2018-004476-35-FR
(EUCTR)
13/08/201920/06/2019Study 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: 20.0;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
20EUCTR2018-004476-35-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 2Colombia;Argentina;Russian Federation;Romania;Hungary;United States;Japan;United Kingdom;Portugal;Greece;Canada;Austria;Netherlands;Sweden;Turkey;Brazil;Korea, Republic of;Italy;Israel;Slovenia;Australia;Chile;France;Germany
21EUCTR2018-004476-35-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 AGNULLNot RecruitingFemale: 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