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Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT02750592
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 will be used to support the registration of secukinumab in Japan for the treatment of active AS.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: secukinumab 150mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 22, 2016
Actual Primary Completion Date : July 5, 2017
Actual Study Completion Date : May 16, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: secukinumab 150mg
A screening (SCR) epoch running 4-10 weeks before baseline (BSL) will be used to assess eligibility followed by 52 weeks of treatment. The treatment periods consist of Treatment period 1 (BSL to Week 24) and Treatment period 2 (Week 24 to Week 52). After Week 52 follows a post-treatment follow-up until Week 60. A follow-up visit is to be done at 12 weeks after last study treatment administration for all patients, regardless of whether they complete the entire study as planned (Week 60) or discontinue prematurely.
Drug: secukinumab 150mg
Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.




Primary Outcome Measures :
  1. Assessment of SpondyloArthritis International Society criteria (ASAS) 20 response [ Time Frame: week 16 ]

    To assess the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS(Assessment of SpondyloArthritis International Society criteria) 20 response.

    The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain



Secondary Outcome Measures :
  1. ASAS 40 response [ Time Frame: Week 16 ]

    The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS 40 response

    ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain


  2. Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 [ Time Frame: Week 16 ]

    The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 response

    The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline


  3. high sensitivity C-Reactive Protein (hsCRP) [ Time Frame: Week 16 ]

    The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline of high sensitivity C-Reactive Protein (hsCRP)

    hsCRP is measured as a marker of inflammation from blood samples during the study


  4. ASAS 5/6 response criteria [ Time Frame: Week 16 ]

    The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients meeting the ASAS 5/6 response criteria

    The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains


  5. BASDAI [ Time Frame: Baseline, week 16 ]

    The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in total BASDAI

    The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS


  6. Short Form Health Survey Physical Component Summary ( SF-36 PCS) [ Time Frame: Baseline, week16 ]

    The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS)

    The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions


  7. Ankylosing Spondylitis Quality of Life (ASQoL) [ Time Frame: Baseline, week16 ]

    The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL)

    The ASQoL is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity)


  8. ASAS partial remission [ Time Frame: Baseline, week16 ]

    The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS partial remission

    The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10


  9. Serum concentration of secukinumab [ Time Frame: Baseline, week 4, 16, 24, 52, 60 ]

    The assessment of pre dose concentration of secukinumab in Japanese AS patients

    An enzyme-linked immunosorbent assay (ELISA) method will be used for bioanalytical analysis of secukinumab in serum, with an anticipated lower limit of quantification (LLOQ) of 80 ng/mL.


  10. Concentration of anti-secukinumab antibodies [ Time Frame: Baseline, week 16, 24, 52, 60 ]

    Assessment of immunogenicity against secukinumab by concentration of anti-secukinumab antibodies at pre-dose.

    An electrochemiluminescence method will be used for the detection of potential anti-secukinumab antibody formation.


  11. Vital sign, clinical laboratory values and adverse event [ Time Frame: Sreenning, Baseline, week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60 ]

    Assessment of overall safety and tolerability of secukinumab

    Vital sign and clinical laboratory value: descriptive statistics for the change from baseline to each analysis visit, the maximum change from baseline, Shift tables of baseline to the most extreme post baseline value and incidence rates of newly occurring or worsening clinically notable abnormalities

    AEs:

    the number and percentage of patients having any AE, having an AE in each primary system organ class and having each individual AE (preferred term), summaries for AEs by severity, separate summaries for AEs possibly related to study treatment, death, serious adverse events, AEs leading to discontinuation and AEs reading to temporary dose interruption and AEs per 100 patient years of exposure




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750592


Locations
Japan
Novartis Investigative Site
Kitakyushu-city, Fukuoka, Japan, 807-8556
Novartis Investigative Site
Kita-gun, Kagawa, Japan, 761-0793
Novartis Investigative Site
Nankoku city, Kochi, Japan, 783 8505
Novartis Investigative Site
Tenri, Nara, Japan, 632-8552
Novartis Investigative Site
Okayama-city, Okayama, Japan, 700-0013
Novartis Investigative Site
Kawachinagano-city, Osaka, Japan, 586-8521
Novartis Investigative Site
Suita-city, Osaka, Japan, 565 0871
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8431
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 104-8560
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-0054
Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02750592     History of Changes
Other Study ID Numbers: CAIN457H1301
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs