106. クリオピリン関連周期熱症候群 Cryopyrin-associated periodic syndrome Clinical trials / Disease details
臨床試験数 : 42 / 薬物数 : 24 - (DrugBank : 4) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 48
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04868968 (ClinicalTrials.gov) | September 20, 2021 | 22/4/2021 | Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS) | An Open-label, Single Arm Phase II Study of DFV890 to Assess the Safety, Tolerability and Efficacy in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS) | Familial Cold Autoinflammatory Syndrome | Drug: DFV890 | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 80 Years | All | 6 | Phase 2 | United States;Germany;Italy |
| 2 | EUCTR2020-005948-33-DE (EUCTR) | 26/07/2021 | 26/02/2021 | Study of safety, tolerability and efficacy of DFV890 in participants with familial cold auto-inflammatory syndrome (FCAS) | An open-label, single arm phase II study of DFV890 to assess the safety, tolerability and efficacy in participants with familial cold auto-inflammatory syndrome (FCAS) | Familial Cold Autoinflammatory Syndrome (FCAS) 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: DFV890 Product Code: DFV890 INN or Proposed INN: Not yet established | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 2 | United States;Germany;Italy | ||
| 3 | EUCTR2020-005948-33-IT (EUCTR) | 07/06/2021 | 08/06/2021 | Study of safety, tolerability and efficacy of DFV890 in participants with familial cold auto-inflammatory syndrome (FCAS) | An open-label, single arm phase II study of DFV890 to assess the safety, tolerability and efficacy in participants with familial cold auto-inflammatory syndrome (FCAS) - - | Familial Cold Autoinflammatory Syndrome (FCAS). 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: - Product Code: [DFV890] | NOVARTIS PHARMA AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 6 | Phase 1;Phase 2 | United States;Germany;Italy | ||
| 4 | NCT04524858 (ClinicalTrials.gov) | October 23, 2020 | 19/8/2020 | Study 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 Therapy | Cryopyrin-Associated Periodic Syndrome | Drug: ATI-450 | Aclaris Therapeutics, Inc. | NULL | Terminated | 18 Years | N/A | All | 1 | Phase 2 | United States |
| 5 | EUCTR2020-000489-40-GB (EUCTR) | 22/09/2020 | 03/04/2020 | A Phase IIb study to Evaluate the Safety, Tolerability and Efficacy of IZD174 in Patients with Cryopyrin-Associated Periodic Syndromes | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 14 | Phase 2 | Ireland;Australia;United Kingdom | ||
| 6 | NCT04086602 (ClinicalTrials.gov) | September 13, 2019 | 9/9/2019 | Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334 | A 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 Syndromes | Healthy Volunteers;Cryopyrin Associated Periodic Syndrome | Drug: IZD334;Drug: Placebos | Inflazome UK Ltd | NULL | Completed | 18 Years | 65 Years | All | 64 | Phase 1 | Australia |
| 7 | NCT03923140 (ClinicalTrials.gov) | May 23, 2019 | 14/4/2019 | A 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 Study | Cryopyrin-Associated Periodic Syndromes | Drug: Tranilast | Peking Union Medical College Hospital | NULL | Recruiting | N/A | N/A | All | 71 | Phase 2 | China |
| 8 | EUCTR2014-001393-34-BE (EUCTR) | 14/04/2014 | 03/04/2014 | 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. | 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 Leuven | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 9 | EUCTR2011-005154-57-GB (EUCTR) | 09/03/2013 | 13/11/2013 | 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). | 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] | Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Canada;Belgium;Spain;Israel;Germany;United Kingdom | ||
| 10 | EUCTR2011-005154-57-FR (EUCTR) | 08/02/2013 | 19/01/2012 | 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). | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | France;Canada;Belgium;Spain;Israel;Germany;United Kingdom | |||
| 11 | EUCTR2009-016859-22-FR (EUCTR) | 04/02/2013 | 14/06/2010 | 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). | 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 INN or Proposed INN: CANAKINUMAB Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 12 | EUCTR2011-005154-57-DE (EUCTR) | 04/06/2012 | 01/02/2012 | 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). | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | France;Canada;Spain;Belgium;Israel;Germany;United Kingdom | |||
| 13 | EUCTR2011-005154-57-ES (EUCTR) | 20/03/2012 | 27/01/2012 | An 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.A | NULL | Not Recruiting | Female: yes Male: yes | 16 | France;Canada;Belgium;Spain;Israel;Germany;United Kingdom | |||
| 14 | NCT01576367 (ClinicalTrials.gov) | January 16, 2012 | 17/2/2012 | Efficacy, 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 Disease | 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) | Cryopyrin-associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory Disease | Biological: ACZ885 | Novartis Pharmaceuticals | NULL | Completed | 1 Year | 4 Years | All | 17 | Phase 3 | Belgium;Canada;France;Germany;Spain;Switzerland;United Kingdom |
| 15 | EUCTR2011-005154-57-BE (EUCTR) | 03/01/2012 | 06/12/2011 | 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). | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | France;Canada;Spain;Belgium;Israel;Germany;United Kingdom | ||
| 16 | EUCTR2009-016859-22-DE (EUCTR) | 11/11/2010 | 22/06/2010 | 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 | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Belgium;Spain;Germany;United Kingdom | |||
| 17 | NCT01302860 (ClinicalTrials.gov) | November 2010 | 22/2/2011 | Efficacy, 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 Disease | 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;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory Disease | Drug: ACZ885 | Novartis Pharmaceuticals | NULL | Completed | 1 Month | 60 Months | All | 17 | Phase 3 | Belgium;Canada;France;Germany;Spain;Switzerland;United Kingdom |
| 18 | EUCTR2009-016859-22-GB (EUCTR) | 15/10/2010 | 01/07/2010 | 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). | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 19 | EUCTR2009-016859-22-ES (EUCTR) | 27/08/2010 | 30/06/2010 | 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) | 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.A | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Belgium;Spain;Germany;United Kingdom | |||
| 20 | NCT01211977 (ClinicalTrials.gov) | August 27, 2010 | 29/9/2010 | A Pilot Study of XOMA 052 in Familial Cold Autoinflammatory Syndrome / Muckle-Wells Syndrome and Behcet's Disease | A 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 Disease | Drug: XOMA 052 | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | United States |
| 21 | EUCTR2009-016859-22-BE (EUCTR) | 12/08/2010 | 14/07/2010 | 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 | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | France;Spain;Belgium;Germany;United Kingdom | |||
| 22 | NCT01105507 (ClinicalTrials.gov) | August 2010 | 25/3/2010 | The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada | An 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 | Drug: canakinumab (company code: ACZ885D) | Novartis Pharmaceuticals | NULL | Completed | 4 Years | N/A | All | 4 | Phase 3 | Canada |
| 23 | EUCTR2007-004367-22-BE (EUCTR) | 16/10/2009 | 21/08/2009 | 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 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 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | France;Spain;Belgium;Germany;Italy;United Kingdom | |||
| 24 | NCT00991146 (ClinicalTrials.gov) | October 2009 | 6/10/2009 | Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase | An 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 Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle-Wells Syndrome;Neonatal Onset Multisystem Inflammatory Disease | Drug: canakinumab | Novartis Pharmaceuticals | NULL | Completed | 2 Years | N/A | All | 19 | Phase 3 | Japan |
| 25 | NCT00770601 (ClinicalTrials.gov) | January 26, 2009 | 9/10/2008 | Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease | A 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 Syndrome | NOMID;CINCA Syndrome | Drug: Canakinumab | Novartis Pharmaceuticals | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Terminated | 2 Years | 25 Years | All | 7 | Phase 3 | United States |
| 26 | NCT01045772 (ClinicalTrials.gov) | January 2009 | 7/1/2010 | Safety 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 Syndrome | Drug: rilonacept | Charite University, Berlin, Germany | NULL | Completed | 18 Years | N/A | Both | 10 | Phase 2 | Germany |
| 27 | EUCTR2006-004290-97-DE (EUCTR) | 19/12/2008 | 17/10/2006 | 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, or Schnitzler’s Syndrome (SchS). - ACCILTRA1 | 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, 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: Rilonacept | Charité Universitätsmedizin Berlin, Department of Dermatology and Allergy | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 28 | EUCTR2007-004367-22-FR (EUCTR) | 18/06/2008 | 03/04/2008 | 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 Muckle-Wells Syndrome with overlapping symptoms of 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | France;Belgium;Spain;Germany;Italy;United Kingdom | |||
| 29 | EUCTR2007-004367-22-DE (EUCTR) | 02/06/2008 | 13/03/2008 | 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 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 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | United Kingdom;Germany;France;Spain;Italy | |||
| 30 | EUCTR2007-004367-22-GB (EUCTR) | 01/05/2008 | 07/03/2008 | 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 | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Spain;Germany;Italy;United Kingdom | ||
| 31 | NCT00685373 (ClinicalTrials.gov) | May 2008 | 27/5/2008 | Efficacy 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 Disease | 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 | Cryopyrin-Associated Periodic Syndromes;Familial Cold Autoinflammatory Syndrome;Muckle Wells Syndrome;Neonatal Onset Multisystem Inflammatory Disease | Drug: Canakinumab (ACZ885) | Novartis | NULL | Completed | 3 Years | N/A | All | 166 | Phase 3 | United States;Belgium;France;Germany;India;Italy;Spain;Turkey;United Kingdom |
| 32 | EUCTR2007-004367-22-IT (EUCTR) | 14/03/2008 | 07/05/2008 | An 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 | An 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 80 | Germany;United Kingdom;France;Spain;Italy | |||
| 33 | EUCTR2004-002980-26-FR (EUCTR) | 07/06/2007 | 29/03/2007 | An 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 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | France;Spain;Germany;United Kingdom | ||
| 34 | NCT00288704 (ClinicalTrials.gov) | December 2005 | 6/2/2006 | Rilonacept 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 Designs | Familial Cold Autoinflammatory Syndrome (FCAS);Familial Cold Urticaria;Muckle-Wells Syndrome (MWS);Genetic Diseases, Inborn | Drug: rilonacept 160 mg;Drug: Placebo | Regeneron Pharmaceuticals | NULL | Completed | 7 Years | N/A | All | 104 | Phase 3 | United States |
| 35 | NCT00069329 (ClinicalTrials.gov) | September 2003 | 22/9/2003 | Anakinra to Treat Patients With Neonatal Onset Multisystem Inflammatory Disease | A 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 Disease | Nervous System Malformations;Arthropathy, Neurogenic;Urticaria;Papilledema | Drug: anakinra | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | Terminated | N/A | N/A | All | 43 | Phase 1/Phase 2 | United States |
| 36 | EUCTR2008-001429-32-Outside-EU/EEA (EUCTR) | 09/03/2012 | A study to check how safe, beneficial and tolerable the drugcanakinumab is for patients with NOMID / CINCA syndrome | A 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 AG | NULL | NA | Female: yes Male: yes | 7 | United States | ||||
| 37 | EUCTR2015-003490-15-Outside-EU/EEA (EUCTR) | 14/04/2016 | Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase | An 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 Pharmaceuticals | NULL | NA | Female: yes Male: yes | 20 | Japan | ||||
| 38 | EUCTR2009-016859-22-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 AG | NULL | NA | Female: yes Male: yes | 15 | Canada;Israel;Switzerland | ||||
| 39 | EUCTR2013-000300-42-Outside-EU/EEA (EUCTR) | 18/01/2013 | A 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: Kineret | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NULL | NA | Female: yes Male: yes | 50 | United States | ||||
| 40 | EUCTR2007-004367-22-Outside-EU/EEA (EUCTR) | 09/03/2012 | A 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 AG | NULL | NA | Female: yes Male: yes | 166 | India;Turkey;United States | ||||
| 41 | EUCTR2009-016859-22-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] | Trade Name: ILARIS Product Name: canakinumab Product Code: ACZ885 INN or Proposed INN: CANAKINUMAB | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Canada;Belgium;Spain;Ireland;Israel;Germany;United Kingdom;Switzerland | |||
| 42 | EUCTR2015-003491-69-Outside-EU/EEA (EUCTR) | 14/04/2016 | The Safety and Efficacy of Canakinumab in Patients Aged 4 Years or Older Diagnosed With Cryopyrin-associated Periodic Syndromes (CAPS) in Canada | An 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 Pharmaceuticals | NULL | NA | Female: yes Male: no | 4 | Canada |