Ly2439821 (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 46 | 悪性関節リウマチ | 4 |
| 271 | 強直性脊椎炎 | 12 |
| 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 | NCT01236118 (ClinicalTrials.gov) | December 2010 | 4/11/2010 | A Study of LY2439821 in Rheumatoid Arthritis | An Open-Label Extension Study to Evaluate Safety and Tolerability of Multiple Subcutaneous Doses of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate | Rheumatoid Arthritis | Drug: LY2439821 | Eli Lilly and Company | NULL | Completed | 20 Years | N/A | All | 28 | Phase 1 | Japan |
| 2 | NCT01253265 (ClinicalTrials.gov) | May 2010 | 1/12/2010 | A Study in Rheumatoid Arthritis | Multiple-Dose, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2439821 in Japanese Patients With Rheumatoid Arthritis on Concomitant Methotrexate Treatment | Rheumatoid Arthritis | Drug: LY2439821;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 20 Years | 75 Years | All | 32 | Phase 1 | Japan |
| 3 | EUCTR2009-009696-34-DE (EUCTR) | 23/11/2009 | 14/05/2009 | A Study in Patients with Rheumatoid Arthritis | A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients with Active Rheumatoid Arthritis on Concomitant DMARD Therapy | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: LY2439821 Product Code: LY2439821 INN or Proposed INN: N.A. | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 648 | Phase 2 | India;Russian Federation;Germany;Peru;Taiwan;Argentina;Romania;Korea, Republic of;Chile;Poland | ||
| 4 | NCT00966875 (ClinicalTrials.gov) | August 2009 | 25/8/2009 | A Study in Patients With Rheumatoid Arthritis | A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy | Rheumatoid Arthritis | Biological: LY2439821;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 75 Years | All | 448 | Phase 2 | United States;Argentina;Chile;Germany;India;Korea, Republic of;Peru;Poland;Romania;Russian Federation;Taiwan;Hungary |
| 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 | NCT04527380 (ClinicalTrials.gov) | January 7, 2021 | 24/8/2020 | A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab With Adalimumab Reference Arm, in Children With Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Psoriatic Arthritis;Enthesitis Related Arthritis | Drug: Ixekizumab;Drug: Adalimumab | Eli Lilly and Company | NULL | Not yet recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | Argentina;Belgium;Czechia;Denmark;France;Germany;Italy;Mexico;Netherlands;Spain;Switzerland;United Kingdom |
| 2 | EUCTR2018-000681-10-GB (EUCTR) | 24/11/2020 | 11/09/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;Switzerland;Italy;United Kingdom | ||
| 3 | EUCTR2018-000681-10-DE (EUCTR) | 23/11/2020 | 07/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 4 | EUCTR2018-000681-10-BE (EUCTR) | 22/10/2020 | 22/10/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 5 | NCT01870284 (ClinicalTrials.gov) | July 2014 | 3/6/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis | Spondylitis, Ankylosing | Drug: Ixekizumab;Drug: Placebo;Drug: Adalimumab | Eli Lilly and Company | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 3 | United States;Argentina;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom |
| 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 |
| 6 | EUCTR2011-002325-22-ES (EUCTR) | 28/10/2013 | 08/08/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 7 | EUCTR2011-002325-22-BE (EUCTR) | 28/10/2013 | 09/08/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;South Africa;Netherlands;Germany | |||
| 8 | EUCTR2011-002325-22-DE (EUCTR) | 25/10/2013 | 09/08/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 9 | EUCTR2011-002325-22-HU (EUCTR) | 26/09/2013 | 17/07/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 16.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Ixekizumab Product Code: LY2439821 INN or Proposed INN: Ixekizumab Other descriptive name: Monoclonal Antibody (MAb) Trade Name: Adalimumab Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 10 | EUCTR2011-002325-22-GB (EUCTR) | 26/09/2013 | 18/06/2013 | Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) | A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients with Active Ankylosing Spondylitis - SPIRIT-A1 | Spondylitis, Ankylosing MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Eli Lilly & Company | NULL | Not Recruiting | Female: yes Male: yes | 408 | Phase 3 | United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany | |||
| 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 |
| 11 | EUCTR2018-000681-10-FR (EUCTR) | 06/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy | |||
| 12 | EUCTR2018-000681-10-DK (EUCTR) | 31/08/2020 | An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis | Multicenter, Open-label, Efficacy, Safety, Tolerability, and Pharmacokinetic Study of Subcutaneous Ixekizumab with Adalimumab Reference Arm, in Children with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis | Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Taltz (80 mg solution for injection in pre-filled syringe) INN or Proposed INN: IXEKIZUMAB Other descriptive name: LY2439821 Trade Name: Humira Product Name: Humira INN or Proposed INN: ADALIMUMAB | Eli Lilly and Company | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | France;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland |