Ixekizumab ( DrugBank: Ixekizumab )


8 diseases
告示番号疾患名(ページ内リンク)臨床試験数
36表皮水疱症1
37膿疱性乾癬(汎発型)1
46悪性関節リウマチ1
107若年性特発性関節炎9
160先天性魚鱗癬1
162類天疱瘡(後天性表皮水疱症を含む。)1
269化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群1
271強直性脊椎炎15

36. 表皮水疱症


臨床試験数 : 163 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-001542-19-FR
(EUCTR)
22/07/202003/04/2020Comparing the Efficacy and Safety of Ixekizumab to Placebo in Patients > 6 years of age with EB simplex generalized severeA 12-Week Multicentre, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Placebo in Patients > 6 years of age with EB simplex generalized severe - EB Epidermolysis bullosa simplex
MedDRA version: 20.0;Level: PT;Classification code 10014989;Term: Epidermolysis bullosa;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: Ixekizumab
Product Name: Taltz 80mg
Product Code: 3400930060797
CHU NICENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
0Phase 2France

37. 膿疱性乾癬(汎発型)


臨床試験数 : 79 薬物数 : 57 - (DrugBank : 21) / 標的遺伝子数 : 20 - 標的パスウェイ数 : 102
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03942042
(ClinicalTrials.gov)
July 5, 20197/5/2019A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic PsoriasisA Multicenter, Open-Label, Post Marketing Clinical Trial to Evaluate the Efficacy And Safety Of Ixekizumab in Patients With Generalized Pustular Psoriasis and Erythrodermic PsoriasisGeneralized Pustular Psoriasis;Erythrodermic PsoriasisDrug: IxekizumabEli Lilly and CompanyNULLCompleted20 YearsN/AAll12Phase 4Japan

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05080218
(ClinicalTrials.gov)
November 15, 20216/10/2021COVID-19 VaccinE Response in Rheumatology PatientsThe SARS-CoV-2 Vaccine Response and Safety in Rheumatology Patients and the Influence of Temporary Interruptions in Immunomodulatory TherapyRheumatoid Arthritis;Psoriatic Arthritis;SpondylarthritisDrug: Upadacitinib;Drug: Abatacept;Drug: Secukinumab;Drug: Tofacitinib;Drug: TNF Inhibitor;Drug: Canakinumab Injection;Drug: Baricitinib;Drug: IxekizumabJeffrey CurtisUniversity of Alabama at Birmingham;University of Nebraska;University of Pennsylvania;AbbVie;Bristol-Myers Squibb;Novartis;Eli Lilly and Company;PfizerRecruiting18 Years85 YearsAll1000Phase 4United States

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04527380
(ClinicalTrials.gov)
April 13, 202124/8/2020A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic ArthritisMulticenter, 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 ArthritisJuvenile Psoriatic Arthritis;Enthesitis Related ArthritisDrug: Ixekizumab;Drug: AdalimumabEli Lilly and CompanyNULLRecruiting2 Years17 YearsAll100Phase 3Argentina;Belgium;Czechia;Denmark;France;Germany;Italy;Mexico;Netherlands;Spain;Switzerland;United Kingdom
2EUCTR2018-000681-10-CZ
(EUCTR)
25/02/202122/12/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Belgium;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Switzerland
3EUCTR2018-000681-10-IT
(EUCTR)
23/12/202024/05/2021An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 - TALZ Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
Product Name: Ixekizumab
Product Code: [TALTZ]
INN or Proposed INN: ixekizumab
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: Adalimumab
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
4EUCTR2018-000681-10-DK
(EUCTR)
14/12/202031/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
5EUCTR2018-000681-10-GB
(EUCTR)
24/11/202011/09/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;Switzerland;Italy;United Kingdom
6EUCTR2018-000681-10-DE
(EUCTR)
23/11/202007/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
7EUCTR2018-000681-10-BE
(EUCTR)
22/10/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
8EUCTR2018-000681-10-NL
(EUCTR)
07/01/2021An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Italy
9EUCTR2018-000681-10-FR
(EUCTR)
06/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy

160. 先天性魚鱗癬


臨床試験数 : 42 薬物数 : 71 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 112
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2200059272
2022-06-012022-04-27A Basket Trial of the Safety and Efficacy of Ixekizumab in Participants with Autoimmune Inflammatory Skin DiseasesA Basket Trial of the Safety and Efficacy of Ixekizumab in Participants with Autoimmune Inflammatory Skin Diseases pityriasis rubra pilaris, hidradenitis suppurativa, Netherton syndrome, erythrokeratodermia variabilis and erythrokeratoderma progressive symmetricapityriasis rubra pilaris, Netherton syndrome, erythrokeratodermia variabilis and erythrokeratoderma progressive symmetrica:Ixekizumab at different doses in adults and juveniles with different body weight;hidradenitis suppurativa:Ixekizumab at different doses in adults and juveniles with different body weight;Dermatology Hospital of Southern Medical UniversityNULLPendingBothpityriasis rubra pilaris, Netherton syndrome, erythrokeratodermia variabilis and erythrokeratoderma progressive symmetrica:30;hidradenitis suppurativa:10;Phase 2China

162. 類天疱瘡(後天性表皮水疱症を含む。)


臨床試験数 : 90 薬物数 : 122 - (DrugBank : 47) / 標的遺伝子数 : 34 - 標的パスウェイ数 : 144
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03099538
(ClinicalTrials.gov)
August 15, 201721/3/2017Ixekizumab in the Treatment of Bullous PemphigoidIxekizumab in the Treatment of Bullous PemphigoidBullous Pemphigoid;PemphigoidDrug: IxekizumabMayo ClinicEli Lilly and CompanyCompleted18 YearsN/AAll4Phase 2United States

269. 化膿性無菌性関節炎・壊疽性膿皮症・アクネ症候群


臨床試験数 : 23 薬物数 : 30 - (DrugBank : 12) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 106
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03137160
(ClinicalTrials.gov)
May 4, 201727/4/2017An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma GangrenosumAn Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma GangrenosumPyoderma GangrenosumBiological: IxekizumabOhio State UniversityEli Lilly and CompanyCompleted18 YearsN/AAll5Phase 2United States

271. 強直性脊椎炎


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04527380
(ClinicalTrials.gov)
April 13, 202124/8/2020A Study of Ixekizumab (LY2439821) in Children With Juvenile Idiopathic Arthritis Categories of Enthesitis-related Arthritis (Including Juvenile Onset Ankylosing Spondylitis) and Juvenile Psoriatic ArthritisMulticenter, 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 ArthritisJuvenile Psoriatic Arthritis;Enthesitis Related ArthritisDrug: Ixekizumab;Drug: AdalimumabEli Lilly and CompanyNULLRecruiting2 Years17 YearsAll100Phase 3Argentina;Belgium;Czechia;Denmark;France;Germany;Italy;Mexico;Netherlands;Spain;Switzerland;United Kingdom
2EUCTR2018-000681-10-CZ
(EUCTR)
25/02/202122/12/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Belgium;Spain;Denmark;Germany;Netherlands;United Kingdom;Italy;Switzerland
3EUCTR2018-000681-10-IT
(EUCTR)
23/12/202024/05/2021An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 - TALZ Juvenile Idiopathic Arthritis subtypes of enthesitis-related arthritis (including juvenile-onset ankylosing spondylitis) and juvenile psoriatic arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Taltz (80 mg solution for injection in pre-filled syringe)
Product Name: Ixekizumab
Product Code: [TALTZ]
INN or Proposed INN: ixekizumab
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: Adalimumab
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
4EUCTR2018-000681-10-DK
(EUCTR)
14/12/202031/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
5EUCTR2018-000681-10-GB
(EUCTR)
24/11/202011/09/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;Switzerland;Italy;United Kingdom
6EUCTR2018-000681-10-DE
(EUCTR)
23/11/202007/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
7NCT01870284
(ClinicalTrials.gov)
July 20143/6/2013Study 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 SpondylitisSpondylitis, AnkylosingDrug: Ixekizumab;Drug: Placebo;Drug: AdalimumabEli Lilly and CompanyNULLWithdrawn18 YearsN/ABoth0Phase 3United States;Argentina;Belgium;Canada;Czech Republic;France;Germany;Hungary;Mexico;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
8EUCTR2011-002325-22-BE
(EUCTR)
28/10/201309/08/2013Study 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 & CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;South Africa;Netherlands;Germany
9EUCTR2011-002325-22-ES
(EUCTR)
28/10/201308/08/2013Study 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 & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
10EUCTR2011-002325-22-DE
(EUCTR)
25/10/201309/08/2013Study 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 & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
11EUCTR2011-002325-22-HU
(EUCTR)
26/09/201317/07/2013Study 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 & CompanyNULLNot RecruitingFemale: yes
Male: yes
408United States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
12EUCTR2011-002325-22-GB
(EUCTR)
26/09/201318/06/2013Study 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]
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 & CompanyNULLNot Recruiting Female: yes
Male: yes
408 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Spain;Ukraine;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;South Africa;Netherlands;Germany
13EUCTR2018-000681-10-BE
(EUCTR)
22/10/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Czech Republic;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy
14EUCTR2018-000681-10-NL
(EUCTR)
07/01/2021An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland;Italy
15EUCTR2018-000681-10-FR
(EUCTR)
06/08/2020An Ixekizumab study with Adalimumab reference arm in children and young adults with Juvenile Idiopathic Arthritis Subtypes of Enthesitis-related ArthritisMulticenter, 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 CompanyNULLNAFemale: yes
Male: yes
100Phase 3France;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy