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 106. クリオピリン関連周期熱症候群 [臨床試験数:15,薬物数:13(DrugBank:4),標的遺伝子数:4,標的パスウェイ数:6] 

Searched query = "Cryopyrin-associated periodic syndrome", "Cryopyrin associated periodic fever syndrome", "Familial cold autoinflammatory syndrome", "FCAS", "Mucke-Wells syndrome", "Chronic infantile neurologic cutaneous, and articular syndrome", "CINCA syndrome", "Neonatal onset multisystem inflammatory disease", "NOMID"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04086602September 13, 201930 September 2019Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of IZD334 in Healthy Adult Participants as Well as an Open-label Cohort to Confirm the Safety, Pharmacokinetics, and Pharmacodynamics in Adult Patients With Cryopyrin-Associated Periodic SyndromesHealthy Volunteers;Cryopyrin Associated Periodic SyndromeDrug: IZD334;Drug: PlacebosInflazome UK LtdRecruiting18 Years65 YearsAll77Phase 1Australia
2NCT03923140May 23, 201917 June 2019A Clinical Study of Tranilast in the Treatment of Cryopyrin-Associated Periodic Syndrome (CAPS)Efficacy and Safety of Tranilast in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS): A Single-Arm Prospective Cohort StudyCryopyrin-Associated Periodic SyndromesDrug: TranilastPeking Union Medical College HospitalRecruitingN/AN/AAll71Phase 2China
3EUCTR2014-001393-34-BE14/04/20147 April 2015Ilaris® (canakinumab) efficacy and safety in CAPS patients without confirmed mutation on exon 3 of gene CIAS1 and young (<2yrs) CAPS patients with severe neurological (CINCA) phenotype.Ilaris® (canakinumab) efficacy and safety in CAPS patients without confirmed mutation on exon 3 of gene CIAS1 and young (<2yrs) CAPS patients with severe neurological (CINCA) phenotype.Cryopyrin-Associated Periodic Syndromes
MedDRA version: 17.1 Level: PT Classification code 10068850 Term: Cryopyrin associated periodic syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Ilaris
Product Name: Ilaris
Pharmaceutical Form: Powder for solution for injection
UZ LeuvenAuthorisedFemale: yes
Male: yes
Belgium
4EUCTR2009-016859-22-FR04/02/201315 July 2013A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS).A one-year open-label, multicenter trial to assess efficacy, safety and tolerability of canakinumab (ACZ885) and the efficacy and safety of childhood vaccinations in patients aged 4 years or younger with Cryopyrin Associated Periodic Syndromes (CAPS).Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 12.1 Level: LLT Classification code 10068850 Term: Cryopyrin associated periodic syndrome
Trade Name: ILARIS
Product Name: Canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
15France;Spain;Germany;United Kingdom
5EUCTR2011-005154-57-BE03/01/201222 August 2016A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).An open-label extension study to assess efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndromes (CAPS) - D2307E1Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 14.0 Level: PT Classification code 10068850 Term: Cryopyrin associated periodic syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Lyophilisate for solution for injection
Route of administration of the placebo: Subcutaneous use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
16Phase 3United Kingdom;Germany;Israel;Belgium;Spain;Canada;France
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT01211977August 27, 201016 December 2017A Pilot Study of XOMA 052 in Familial Cold Autoinflammatory Syndrome / Muckle-Wells Syndrome and Behcet's DiseaseA Pilot Study of XOMA 052 in Familial Cold Autoinflammatory Syndrome (FCAS) / Muckle-Wells Syndrome (MWS) and Behcet's Disease (BD)Muckle Wells Syndrome;Autoinflammatory;Behcet's DiseaseDrug: XOMA 052National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 YearsN/AAll0Phase 1/Phase 2United States
7NCT01105507August 201016 December 2017The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in CanadaAn Open Label Study to Assess the Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in CanadaCryopyrin Associated Periodic SyndromeDrug: canakinumab (company code: ACZ885D)Novartis PharmaceuticalsNot recruiting4 YearsN/AAll4Phase 3Canada
8NCT00991146October 200916 December 2017Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension PhaseAn Open-label, Efficacy and Safety Study of Canakinumab (Anti-interleukin-1ß Monoclonal Antibody) Administered for 6 Months (24 Weeks) in Japanese Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease, Followed by an Extension Phase to Provide Canakinumab to Study Patients Until it is Approved and Marketed in JapanCryopyrin-associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory DiseaseDrug: canakinumabNovartis PharmaceuticalsNot recruiting2 YearsN/AAll19Phase 3Japan
9NCT00770601January 200919 February 2015Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory DiseaseA Multi-Center, Open Label, 24-Month Treatment Study to Establish the Safety, Tolerability, Efficacy, Pharmacokinetics of Canakinumab (Anti-IL-1 Beta Antibody) in Patients With NOMID / CINCA SyndromeNOMID;CINCA SyndromeDrug: CanakinumabNovartis PharmaceuticalsNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting2 Years25 YearsBoth6Phase 3United States
10EUCTR2006-004290-97-DE19/12/200819 March 2012A Single-Centre, Open Label Study of the Safety and Tolerability of Rilonacept in Subjects Living in Germany with Muckle-Wells Syndrome (MWS), a Cryopyrin-Associated Periodic Syndrome, or Schnitzler’s Syndrome (SchS). - ACCILTRA1A Single-Centre, Open Label Study of the Safety and Tolerability of Rilonacept in Subjects Living in Germany with Muckle-Wells Syndrome (MWS), a Cryopyrin-Associated Periodic Syndrome, or Schnitzler’s Syndrome (SchS). - ACCILTRA1The medical condition to be investigated was first described by Muckle and Wells 1962. The Muckle-Wells syndrome (MWS) is rare and characterized by chronic recurrent urticaria, periodic arthritis, sensorineural deafness, general signs of inflammation and secondary amyloidosis. Schnitzler syndrome (SchS) is rare and characterized by chronic, nonpruritic urticaria and a monoclonal immunoglobulin M gammopathy. Symptoms are recurrent fever, bone pain, muscle pain, arthralgia or arthritis.Trade Name: Rilonacept
Pharmaceutical Form: Solution for injection
Charité Universitätsmedizin Berlin, Department of Dermatology and AllergyNot RecruitingFemale: yes
Male: yes
Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2007-004367-22-GB01/05/200819 March 2012An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease - D2306An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease - D2306The following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 9.1 Level: LLT Classification code 10064569 Term: Muckle-Wells syndrome
Product Name: ACZ885
Product Code: ACZ885
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Canakinumab (WHO approval pending)
CAS Number: -
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150 mg-
Novartis Pharma Services AGAuthorisedFemale: yes
Male: yes
80Germany;United Kingdom;France;Spain;Italy
12NCT00685373May 200819 October 2017Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory DiseaseAn Open-label, Long-term Safety and Efficacy Study of ACZ885 (Anti-interleukin-1ß Monoclonal Antibody) Administered for at Least 6 Months in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory DiseaseCryopyrin-Associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle Wells Syndrome;Neonatal Onset Multisystem Inflammatory DiseaseDrug: Canakinumab (ACZ885)NovartisNot recruiting3 YearsN/AAll166Phase 3United States;Belgium;France;Germany;India;Italy;Spain;Turkey;United Kingdom
13EUCTR2008-001429-32-Outside-EU/EEA20 March 2012A study to check how safe, beneficial and tolerable the drug canakinumab is for patients with NOMID / CINCA syndromeA multi-center, open label, 24-month treatment study to establish the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of canakinumab (anti-IL-1 beta antibody) in patients with NOMID / CINCA syndromeNeonatal onset multisystem inflammatory disease (abbreviated NOMID, also known as chronic infantile neurologic cutaneous and articular syndrome or CINCA)
MedDRA version: 14.1 Level: PT Classification code 10068850 Term: Cryopyrin associated periodic syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Novartis Pharma Services AGNot AvailableFemale: yes
Male: yes
7United States
14NCT00288704December 200519 October 2017Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)IL1T-AI-0505: A Multi-center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, & Efficacy of Rilonacept in Subjects With Cryopyrin-Associated Periodic Syndromes (CAPS) Using Parallel Group & Randomized Withdrawal DesignsFamilial Cold Autoinflammatory Syndrome (FCAS);Familial Cold Urticaria;Muckle-Wells Syndrome (MWS);Genetic Diseases, InbornDrug: rilonacept 160 mg;Drug: PlaceboRegeneron PharmaceuticalsNot recruiting7 YearsN/AAll104Phase 3United States
15NCT00069329September 200319 October 2017Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory DiseaseA Long-Term Outcome Study With the IL-1 Receptor Antagonist Anakinra/Kineret in Patients With Neonatal Onset Multisystem Inflammatory Disease (NOMID/CINCA Syndrome) A Therapeutic Approach to Study the Pathogenesis of This DiseaseNervous System Malformations;Arthropathy, Neurogenic;Urticaria;PapilledemaDrug: anakinraNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruitingN/AN/AAll43Phase 1/Phase 2United States

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