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：44］
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 of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04086602 | September 13, 2019 | 30 September 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 | Recruiting | 18 Years | 65 Years | All | 77 | Phase 1 | Australia | |
| 2 | NCT03923140 | May 23, 2019 | 17 June 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 | Recruiting | N/A | N/A | All | 71 | Phase 2 | China | |
| 3 | EUCTR2014-001393-34-BE | 14/04/2014 | 7 April 2015 | 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 Pharmaceutical Form: Powder for solution for injection | UZ Leuven | Authorised | Female: yes Male: yes | Belgium | |||||
| 4 | EUCTR2009-016859-22-FR | 04/02/2013 | 15 July 2013 | 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 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 AG | Authorised | Female: yes Male: yes | 15 | France;Spain;Germany;United Kingdom | ||||
| 5 | EUCTR2011-005154-57-BE | 03/01/2012 | 22 August 2016 | 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 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 AG | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | United Kingdom;Germany;Israel;Belgium;Spain;Canada;France | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT01211977 | August 27, 2010 | 16 December 2017 | 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) | Not recruiting | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | United States | |
| 7 | NCT01105507 | August 2010 | 16 December 2017 | 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 | Not recruiting | 4 Years | N/A | All | 4 | Phase 3 | Canada | |
| 8 | NCT00991146 | October 2009 | 16 December 2017 | 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 | Not recruiting | 2 Years | N/A | All | 19 | Phase 3 | Japan | |
| 9 | NCT00770601 | January 2009 | 19 February 2015 | 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) | Not recruiting | 2 Years | 25 Years | Both | 6 | Phase 3 | United States |
| 10 | EUCTR2006-004290-97-DE | 19/12/2008 | 19 March 2012 | 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 Pharmaceutical Form: Solution for injection | Charité Universitätsmedizin Berlin, Department of Dermatology and Allergy | Not Recruiting | Female: yes Male: yes | Germany | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2007-004367-22-GB | 01/05/2008 | 19 March 2012 | 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 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 AG | Authorised | Female: yes Male: yes | 80 | Germany;United Kingdom;France;Spain;Italy | ||||
| 12 | NCT00685373 | May 2008 | 19 October 2017 | 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 | Not recruiting | 3 Years | N/A | All | 166 | Phase 3 | United States;Belgium;France;Germany;India;Italy;Spain;Turkey;United Kingdom | |
| 13 | EUCTR2008-001429-32-Outside-EU/EEA | 20 March 2012 | A study to check how safe, beneficial and tolerable the drug canakinumab 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 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 AG | Not Available | Female: yes Male: yes | 7 | United States | |||||
| 14 | NCT00288704 | December 2005 | 19 October 2017 | 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 | Not recruiting | 7 Years | N/A | All | 104 | Phase 3 | United States | |
| 15 | NCT00069329 | September 2003 | 19 October 2017 | 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) | Not recruiting | N/A | N/A | All | 43 | Phase 1/Phase 2 | United States |