Cfz533    (DrugBank: -)

4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
11重症筋無力症3
46悪性関節リウマチ1
49全身性エリテマトーデス5
53シェーグレン症候群18

11. 重症筋無力症 [臨床試験数:226,薬物数:172(DrugBank:45),標的遺伝子数:43,標的パスウェイ数:118
Searched query = "Myasthenia", "MG"
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.
3 / 226 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02565576
(ClinicalTrials.gov)
September 29, 201523/6/2015Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia GravisA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Preliminarily Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of CFZ533 in Patients With Moderate to Severe Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: Placebo;Drug: CFZ533Novartis PharmaceuticalsNULLCompleted18 Years85 YearsAll44Phase 2Canada;Denmark;Germany;Russian Federation;Taiwan
2EUCTR2015-000097-35-DK
(EUCTR)
03/09/201516/06/2015Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine.
MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
44Phase 2Taiwan;Canada;Denmark;Russian Federation;Germany
3EUCTR2015-000097-35-DE
(EUCTR)
02/09/201505/06/2015Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine.
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
Other descriptive name: CFZ533
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
44Phase 2Taiwan;Canada;Denmark;Russian Federation;Germany

46. 悪性関節リウマチ [臨床試験数:4,183,薬物数:2,538(DrugBank:401),標的遺伝子数:183,標的パスウェイ数:219
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
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 / 4,183 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02089087
(ClinicalTrials.gov)
January 7, 201313/3/2014Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose CFZ533 in Rheumatoid Arthritis PatientsA Randomized, Double-blind, Placebo-controlled, Single Ascending Dose First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CFZ533 in Healthy Subjects and Rheumatoid Arthritis PatientsRheumatoid ArthritisBiological: CFZ533;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll75Phase 1United States;Taiwan

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.
5 / 827 trials 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-FR
(EUCTR)
05/02/201913/11/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE)
MedDRA version: 20.0;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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 2Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
2NCT03656562
(ClinicalTrials.gov)
December 19, 201819/7/2018Study the Efficacy and Safety of VAY736 and CFZ533 in SLE PatientsA Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus (SLE)Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 PlaceboNovartis PharmaceuticalsNULLRecruiting18 Years75 YearsAll120Phase 2Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Thailand
3EUCTR2018-001508-12-ES
(EUCTR)
12/12/201809/10/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) Systemic lupus erythematosus (SLE)
MedDRA version: 20.0;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]
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120Phase 2Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
4EUCTR2018-001508-12-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
5EUCTR2018-001508-12-CZ
(EUCTR)
02/11/201828/08/2018Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE) A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
135Phase 2Taiwan;Spain;Thailand;Russian Federation;Israel;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.
18 / 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
8NCT03905525
(ClinicalTrials.gov)
October 1, 201925/3/2019Study 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)Sjögren SyndromeDrug: CFZ533;Other: PlaceboNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll260Phase 2United States;Australia;Austria;Brazil;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Russian Federation;Slovenia;Turkey;United Kingdom
9EUCTR2018-004476-35-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
10EUCTR2018-004476-35-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
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-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
12EUCTR2018-004476-35-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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: 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
13EUCTR2018-004476-35-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
14EUCTR2018-004476-35-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
15EUCTR2013-004808-19-DE
(EUCTR)
05/02/201607/12/2015Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's primary Sjögren’s 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 Code: CFZ533
INN or Proposed INN: Not yet established
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
66Phase 2United States;Hungary;Germany;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02291029
(ClinicalTrials.gov)
October 22, 20144/11/2014Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's SyndromeA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CFZ533 in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: CFZ533 active - Cohort 1;Drug: CFZ533 placebo- Cohort 1;Drug: CFZ533 active - Cohort 2;Drug: CFZ533 placebo - Cohort 2;Drug: CFZ533 active -Cohort 3;Drug: CFZ533 active - Cohort 3Novartis PharmaceuticalsNULLCompleted18 Years75 YearsAll69Phase 2United States;Germany;Hungary;Switzerland;United Kingdom
17EUCTR2013-004808-19-GB
(EUCTR)
23/07/201407/03/2014Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's primary Sjögren’s 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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
66Phase 2United States;Hungary;Germany;Switzerland;United Kingdom
18EUCTR2013-004808-19-HU
(EUCTR)
02/07/201406/05/2014Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's primary Sjögren’s syndrome
MedDRA version: 18.1;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 Code: CFZ533
INN or Proposed INN: Not yet established
Product Code: CFZ533
INN or Proposed INN: Not yet established
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Hungary;Germany;United Kingdom;Switzerland