106. クリオピリン関連周期熱症候群
[臨床試験数:39,薬物数:23(DrugBank:4),標的遺伝子数:4,標的パスウェイ数:46

Searched query = "Cryopyrin-associated periodic syndrome", "Cryopyrin associated periodic fever syndrome", "Familial cold autoinflammatory syndrome", "FCAS", "Mucke-Wells syndrome", "MWS", "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: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04524858
(ClinicalTrials.gov)
October 23, 202019/8/2020Study of ATI-450 in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS)A Phase 2a, Open-Label, Single-Arm Study to Investigate the Safety and Efficacy of ATI-450 for the Maintenance of Remission in Patients With Cryopyrin-Associated Periodic Syndrome (CAPS) Previously Managed With Anti-IL-1 TherapyCryopyrin-Associated Periodic SyndromeDrug: ATI-450Aclaris Therapeutics, Inc.NULLRecruiting18 YearsN/AAll10Phase 2United States
2EUCTR2020-000489-40-GB
(EUCTR)
22/09/202003/04/2020A Phase IIb study to Evaluate the Safety, Tolerability and Efficacy of IZD174 in Patients with Cryopyrin-Associated Periodic SyndromesA Multi-Centre, Randomised, Open-Label, Phase IIb Study to Evaluate the Safety, Tolerability and Efficacy of IZD174 in Patients with Cryopyrin Associated Periodic Syndromes Cryopyrin-associated periodic syndrome (CAPS)
MedDRA version: 20.0;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]
Product Name: IZD174
Product Code: C-028380
INN or Proposed INN: N/A
Other descriptive name: Inzomelid
Product Name: IZD174
Product Code: C-028380
INN or Proposed INN: N/A
Other descriptive name: Inzomelid
Inflazome (Australia) Pty Ltd.NULLNot RecruitingFemale: yes
Male: yes
14Phase 2Ireland;Australia;United Kingdom
3NCT04086602
(ClinicalTrials.gov)
September 13, 20199/9/2019Safety 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 LtdNULLCompleted18 Years65 YearsAll64Phase 1Australia
4NCT03923140
(ClinicalTrials.gov)
May 23, 201914/4/2019A 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 HospitalNULLRecruitingN/AN/AAll71Phase 2China
5EUCTR2014-001393-34-BE
(EUCTR)
14/04/201403/04/2014Ilaris® (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
UZ LeuvenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-005154-57-GB
(EUCTR)
09/03/201313/11/2013A 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) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 17.0;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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
16Phase 3France;Canada;Belgium;Spain;Israel;Germany;United Kingdom
7EUCTR2011-005154-57-FR
(EUCTR)
08/02/201319/01/2012A 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) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
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]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
16France;Canada;Belgium;Spain;Israel;Germany;United Kingdom
8EUCTR2009-016859-22-FR
(EUCTR)
04/02/201314/06/2010A 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
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
15Phase 3France;Belgium;Spain;Ireland;Germany;United Kingdom
9EUCTR2011-005154-57-DE
(EUCTR)
04/06/201201/02/2012A 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) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
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]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
16France;Canada;Spain;Belgium;Israel;Germany;United Kingdom
10EUCTR2011-005154-57-ES
(EUCTR)
20/03/201227/01/2012An extension study to check how safe, beneficial and tolerable the drugcanakinumab, along with childhood vaccines, is for patients with crypoyrin associated periodic syndromes (CAPS).An open-label extension study to assess efficacy, safety and tolerabilityof canakinumab and the efficacy and safety of childhood vaccinations inpatients with Cryopyrin Associated Periodic Syndromes (CAPS) - D2307E1 Cryopyrin Associated Periodic Syndromes (CAPS)
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]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
16France;Canada;Belgium;Spain;Israel;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT01576367
(ClinicalTrials.gov)
January 16, 201217/2/2012Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory DiseaseAn 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)Cryopyrin-associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory DiseaseBiological: ACZ885Novartis PharmaceuticalsNULLCompleted1 Year4 YearsAll17Phase 3Belgium;Canada;France;Germany;Spain;Switzerland;United Kingdom
12EUCTR2011-005154-57-BE
(EUCTR)
03/01/201206/12/2011A 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) - D2307E1 Cryopyrin 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
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
16Phase 3France;Canada;Spain;Belgium;Israel;Germany;United Kingdom
13EUCTR2009-016859-22-DE
(EUCTR)
11/11/201022/06/2010A 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). - D2307A 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). - D2307 Cryopyrin Associated Periodic Syndromes (CAPS)
MedDRA version: 12.1;Level: LLT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome
Trade Name: ILARIS
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
15France;Belgium;Spain;Germany;United Kingdom
14NCT01302860
(ClinicalTrials.gov)
November 201022/2/2011Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory DiseaseA 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;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory DiseaseDrug: ACZ885Novartis PharmaceuticalsNULLCompleted1 Month60 MonthsAll17Phase 3Belgium;Canada;France;Germany;Spain;Switzerland;United Kingdom
15EUCTR2009-016859-22-GB
(EUCTR)
15/10/201001/07/2010A 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: 17.0;Level: PT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
15Phase 3France;Belgium;Spain;Ireland;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2009-016859-22-ES
(EUCTR)
27/08/201030/06/2010Ensayo multicéntrico abierto de un año de seguimiento para evaluar la eficacia, seguridad y tolerabilidad de canakinumab (ACZ885) y la eficacia y seguridad de las vacunas pediátricas en pacientes de 4 años de edad o menores con Síndromes Periódicos Asociados a Criopirina (CAPS)Ensayo multicéntrico abierto de un año de seguimiento para evaluar la eficacia, seguridad y tolerabilidad de canakinumab (ACZ885) y la eficacia y seguridad de las vacunas pediátricas en pacientes de 4 años de edad o menores con Síndromes Periódicos Asociados a Criopirina (CAPS) Síndromes Periódicos Asociados a Criopirina (CAPS)
MedDRA version: 12.1;Level: LLT;Classification code 10068850;Term: Cryopyrin associated periodic syndrome
Product Name: CANAKINUMAB
INN or Proposed INN: CANAKINUMAB
Other descriptive name: CANAKINUMAB
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
15France;Belgium;Spain;Germany;United Kingdom
17NCT01211977
(ClinicalTrials.gov)
August 27, 201029/9/2010A 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)NULLWithdrawn18 YearsN/AAll0Phase 1;Phase 2United States
18EUCTR2009-016859-22-BE
(EUCTR)
12/08/201014/07/2010A 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). - D2307A 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). - D2307 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
INN or Proposed INN: CANAKINUMAB
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
15France;Spain;Belgium;Germany;United Kingdom
19NCT01105507
(ClinicalTrials.gov)
August 201025/3/2010The 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 PharmaceuticalsNULLCompleted4 YearsN/AAll4Phase 3Canada
20EUCTR2007-004367-22-BE
(EUCTR)
16/10/200921/08/2009An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of 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 thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306 The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab (WHO approval pending)
Other descriptive name: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
80France;Spain;Belgium;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00991146
(ClinicalTrials.gov)
October 20096/10/2009Efficacy 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 PharmaceuticalsNULLCompleted2 YearsN/AAll19Phase 3Japan
22NCT00770601
(ClinicalTrials.gov)
January 20099/10/2008Canakinumab 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)Terminated2 Years25 YearsAll6Phase 3United States
23NCT01045772
(ClinicalTrials.gov)
January 20097/1/2010Safety and Tolerability of Rilonacept in Muckle-Wells Syndrome (MWS) or Schnitzler Syndrome (SchS)A 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 (CAPS), or Schnitzler Syndrome (SchS)Muckle-Wells Syndrome;Schnitzler SyndromeDrug: rilonaceptCharite University, Berlin, GermanyNULLCompleted18 YearsN/ABoth10Phase 2Germany
24EUCTR2006-004290-97-DE
(EUCTR)
19/12/200817/10/2006A 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). - ACCILTRA1 The 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: RilonaceptCharité Universitätsmedizin Berlin, Department of Dermatology and AllergyNULLNot RecruitingFemale: yes
Male: yes
Germany
25EUCTR2007-004367-22-FR
(EUCTR)
18/06/200803/04/2008An 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 Muckle-Wells Syndrome with overlapping symptoms of 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 Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease. - D2306 The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome
Product Name: ACZ885
Product Code: ACZ885
INN or Proposed INN: Canakinumab (WHO approval pending)
Other descriptive name: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
80France;Belgium;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2007-004367-22-DE
(EUCTR)
02/06/200813/03/2008An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1ß monoclonal antibody) administered for at least 6 months in patients with thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of 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 thefollowing cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Muckle-Wells Syndrome with overlappingsymptoms of Neonatal Onset Multisystem Inflammatory Disease - D2306 The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease
MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome
Product Code: ACZ885
INN or Proposed INN: Canakinumab (WHO approval pending)
Other descriptive name: Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
80United Kingdom;Germany;France;Spain;Italy
27EUCTR2007-004367-22-GB
(EUCTR)
01/05/200807/03/2008 An 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 - D2306 An 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 - D2306 The 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
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
80Phase 3France;Belgium;Spain;Germany;Italy;United Kingdom
28NCT00685373
(ClinicalTrials.gov)
May 200827/5/2008Efficacy 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)NovartisNULLCompleted3 YearsN/AAll166Phase 3United States;Belgium;France;Germany;India;Italy;Spain;Turkey;United Kingdom
29EUCTR2007-004367-22-IT
(EUCTR)
14/03/200807/05/2008An open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1β 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 Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease - NDAn open-label, long-term safety and efficacy study of ACZ885 (anti-interleukin-1β 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 Muckle-Wells Syndrome with overlapping symptoms of Neonatal Onset Multisystem Inflammatory Disease - ND Muckle-Wells Syndrome, Familial Cold autoinflammatory syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10064569;Term: Muckle-Wells syndrome
Product Name: anti-interleukin-1B monoclonal antibody
Product Code: ACZ885
INN or Proposed INN: anti-interleukin-1B monoclonal antibody
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
80Germany;United Kingdom;France;Spain;Italy
30EUCTR2004-002980-26-FR
(EUCTR)
07/06/200729/03/2007An open-label, phase II dose titration study of ACZ885 (human anti-IL-1beta monoclonal antibody) to assess the clinical efficacy, safety, pharmacokinetics and pharmacodynamics in patients with NALP3 mutations - A2102An open-label, phase II dose titration study of ACZ885 (human anti-IL-1beta monoclonal antibody) to assess the clinical efficacy, safety, pharmacokinetics and pharmacodynamics in patients with NALP3 mutations - A2102 Muckle-Wells Syndrome: rare hereditary, autosomal dominant, systemic inflammatory disease, characterized by recurrent episodes of fever, arthralgia, myalgia, urticarial rash, and conjunctivitis. Laboratory findings show an elevation of acute phase proteins such as CRP and SAA, a high ESR, together with leukocytosis, and hypergammaglobulinemia. Severe long term complications include progressive sensorineural deafness, and systemic AA amyloidosis.
MedDRA version: 9.1;Level: LLT;Classification code 10064573;Term: Neonatal-onset multisystemic inflammatory disease
MedDRA version: 9.1;Classification code 10064570;Term: Familial cold autoinflammatory syndrome
Product Code: ACZ885
Other descriptive name: ACZ885 drug substance
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
34Phase 2France;Spain;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00288704
(ClinicalTrials.gov)
December 20056/2/2006Rilonacept 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 PharmaceuticalsNULLCompleted7 YearsN/AAll104Phase 3United States
32NCT00069329
(ClinicalTrials.gov)
September 200322/9/2003Anakinra 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)NULLTerminatedN/AN/AAll43Phase 1;Phase 2United States
33EUCTR2009-016859-22-Outside-EU/EEA
(EUCTR)
09/03/2012?A study to check how safe, beneficial and tolerable the drugcanakinumab, along with childhood vaccines, is for patients withCryopyrin Associated Periodic Syndromes (CAPS).A one-year open-label, multicenter trial to assess efficacy, safety andtolerability of canakinumab (ACZ885) and the efficacy and safety ofchildhood vaccinations in patients aged 4 years or younger withCryopyrin Associated Periodic Syndromes (CAPS). - D2307 Cryopyrin Associated Periodic Syndromes (CAPS)
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]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
15Canada;Israel;Switzerland
34EUCTR2009-016859-22-IE
(EUCTR)
07/03/2013 ?A study to check how safe, beneficial and tolerable the drug canakinumab, along with childhood vaccines, is for patients with Crypoyrin 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). - D2307 Cryopyrin Associated Periodic Syndromes (CAPS)
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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
15Phase 3France;Canada;Belgium;Spain;Ireland;Israel;Germany;United Kingdom;Switzerland
35EUCTR2008-001429-32-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drugcanakinumab 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 syndrome Neonatal 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
INN or Proposed INN: CANAKINUMAB
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
7United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2013-000300-42-Outside-EU/EEA
(EUCTR)
18/01/2013A long-term study with the IL-1 receptor blocker anakinra/kineret® in patients with neonatal onset multisystem inflammatory disease (NOMID/CINCA syndrome)A long-term outcome study with the IL-1 receptor antagonist Anakinra/Kineret® in patients with Neonatal onset multisystem inflammatory disease (Nomid/Cinca syndrome) neonatal onset multisystem inflammatory disease (NOMID/CINCA);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Trade Name: KineretNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLNAFemale: yes
Male: yes
50United States
37EUCTR2015-003490-15-Outside-EU/EEA
(EUCTR)
14/04/2016Efficacy 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 Japan Cryopyrin-associated Periodic SyndromesFamilial Cold Autoinflammatory SyndromeMuckle-Wells SyndromeNeonatal Onset Multisystem Inflammatory Disease
MedDRA version: 19.0;Level: PT;Classification code 10064570;Term: Familial cold autoinflammatory syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Level: LLT;Classification code 10064574;Term: NOMID;Classification code 10068850;Term: Cryopyrin associated periodic syndrome;Classification code 10064569;Term: Muckle-Wells 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: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis PharmaceuticalsNULLNAFemale: yes
Male: yes
20Phase AJapan
38EUCTR2007-004367-22-Outside-EU/EEA
(EUCTR)
09/03/2012A study to check how safe, beneficial and tolerable the drugcanakinumab is for patients with Crypoyrin Associated Periodic Syndromes (CAPS).An 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 - D2306 The following cryopyrin-associated periodic syndromes:Familial Cold Autoinflammatory Syndrome,Muckle-Wells Syndrome,or Neonatal Onset Multisystem Inflammatory Disease
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]
Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
INN or Proposed INN: CANAKINUMAB
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
166India;Turkey;United States
39EUCTR2015-003491-69-Outside-EU/EEA
(EUCTR)
14/04/2016The 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 Canada Cryopyrin Associated Periodic Syndrome
MedDRA version: 19.0;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
INN or Proposed INN: CANAKINUMAB
Novartis PharmaceuticalsNULLNAFemale: yes
Male: no
4Canada