Clinical trial NCT02750592: Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
Official title: An Open-label, Phase III, Study of Subcutaneous Secukinumab to Assess Efficacy, Safety and Tolerability at up to 52 Weeks in Japanese Patients With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
secukinumab
AIN457H
SpondyloArthritis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the clinical efficacy, safety and tolerability of secukinumab subcutaneous injections up to 52 weeks in Japanese patients with active AS despite current or previous non-steroidal anti-inflammatory drugs (NSAIDs) and/or anti-tumor necrosis factor (TNF) α therapy. Efficacy and safety data were used to support the registration of secukinumab in Japan for the treatment of active AS.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe AS with prior documented radiologic evidence (x-ray or radiologist's report) fulfilling the Modified New York criteria for AS with active AS assessed by BASDAI ≥ 4 (0-10) and spinal pain as measured by VAS≥ 4 cm (BASDAI question #2) at Baseline
* Patients should have been on NSAIDs at the highest recommended dose for at least 3 months prior to baseline with an inadequate response or failure to respond, or less than 3 months if therapy had to be withdrawn due to intolerance, toxicity or contraindications
* Patients who have been on a TNFα inhibitor (not more than one) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to baseline or have been intolerant to at least one administration of an anti-TNFα agent

Exclusion Criteria:

* Patients with total ankylosis of the spine
* Patients previously treated with any biological immunomodulating agents except for those targeting TNFα
* Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of secukinumab therapy, including inflammatory bowel disease or uveitis
* Known infection with HIV, hepatitis B or hepatitis C at screening or baseline

Primary outcomes:
measure: Assessment of SpondyloArthritis International Society 20 Response (ASAS20)
timeFrame: week 16
Secondary outcomes:
measure: ASAS 40 Response Rate With Non-responder Imputation (NRI)
timeFrame: Week 16
measure: Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate
timeFrame: Week 16
measure: Change in High Sensitivity C-Reactive Protein (hsCRP)
timeFrame: baseline, Week 16
measure: Number of Participants With ASAS 5/6 Response Criteria
timeFrame: Week 16
measure: Mean Change From Baseline in BASDAI From Baseline
timeFrame: Baseline, week 16
measure: Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score
timeFrame: Baseline, week 16
measure: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score
timeFrame: Baseline, week 16
measure: Proportion of Participants Achieving ASAS Partial Remission
timeFrame: week 16
measure: Change in Serum Concentration of Secukinumab
timeFrame: Baseline, weeks 4, 16, 24, 52, 60
measure: Number of Participants With Immunogenicity Against Secukinumab
timeFrame: week 60
measure: Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood
timeFrame: week 60
measure: Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade
timeFrame: week 60
measure: Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities
timeFrame: week 60
measure: Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities
timeFrame: week 60
measure: Participants With Newly Occurring Notable Abnormalities in Vital Signs
timeFrame: week 60
Other outcomes:
Locations:
city: Kitakyushu-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Kita-gun
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Nankoku city
country: Japan
facility: Novartis Investigative Site
state: Kochi
city: Tenri
country: Japan
facility: Novartis Investigative Site
state: Nara
city: Okayama-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kawachinagano
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Bunkyo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: