Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
271強直性脊椎炎6

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_
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agemin
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PhaseCountries
1EUCTR2009-011591-30-GB
(EUCTR)
21/09/201020/10/2009An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 Ankylosing spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;Netherlands;United Kingdom
2EUCTR2009-011591-30-NL
(EUCTR)
17/05/201018/11/2009Safety and tolerability of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitisAn open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 Ankylosing spondylitis
MedDRA version: 14.1;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: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United States;Germany;Netherlands;United Kingdom
3EUCTR2009-011591-30-DE
(EUCTR)
03/03/201008/12/2009An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 Ankylosing spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Netherlands;Germany;United Kingdom
4EUCTR2008-002631-33-NL
(EUCTR)
23/02/200917/09/2008Efficacy of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitisRandomized, double-blind, placebo-controlled, multi-center, phase II, proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 ankylosing spondylitis
MedDRA version: 13.1;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: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;United Kingdom;Netherlands
5EUCTR2008-002631-33-GB
(EUCTR)
14/01/200925/07/2008Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209 Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Germany;United Kingdom;Netherlands
6EUCTR2008-002631-33-DE
(EUCTR)
15/12/200820/08/2008Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis
Product Name: AIN457
Product Code: AIN457
Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United Kingdom;Germany;Netherlands