A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis

Brief Title

A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis

Official Title

A Multicenter Study Evaluating the Efficacy and Safety of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis.

Brief Summary

      The purpose of this study is to evaluate the safety and efficacy of secukinumab 300mg in
      Chinese adults participants with active ankylosing spondylitis (AS) who have had an
      inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or
      intolerance to or a contraindication for NSAIDs, and who are naïve to biologic
      disease-modifying anti-rheumatic drugs (bDMARD).
    

Detailed Description

      This study includes two periods: a 16-week double-blind placebo-controlled period and a
      52-week open-label long-term extension period.

      Eligible participants were randomly assigned in a 1:1 ratio to receive secukinumab 300 mg or
      placebo for 16 weeks in Period 1.

      Participants who completed Period 1 received secukinumab 300 mg for 36 weeks in the extension
      period.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24

Secondary Outcome

 Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48

Condition

Ankylosing Spondylitis (AS)

Intervention

Secukinumab 300mg s.c.

Study Arms / Comparison Groups

 Secukinumab 300mg
Description:  Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 300 mg s.c. every 4 weeks for an additional 48 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

100

Start Date

June 14, 2021

Completion Date

August 31, 2022

Primary Completion Date

August 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the
             modified New York criteria for AS.

          -  Participant must have baseline disease activity as defined by having a Bath Ankylosing
             Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of
             ●Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the
             Screening and Baseline visits.

          -  Participant has had an inadequate response to at least two nonsteroidal
             anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum
             recommended or tolerated doses, or participant has an intolerance to or
             contraindication for NSAIDs as defined by the Investigator.

          -  If entering the study on concomitant methotrexate (MTX), leflunomide, sulfasalazine
             (SSZ), and/or hydroxychloroquine, participant must be on a stable dose of MTX (<= 25
             mg/week) and/or SSZ (<= 3 g/day) and/or hydroxychloroquine (<= 400 mg/day) or
             leflunomide (<= 20 mg/day) for at least 28 days prior to the Baseline visit. A
             combination of up to two background conventional synthetic disease-modifying
             anti-rheumatic drugs (csDMARDs) is allowed except the combination of MTX and
             leflunomide.

          -  If entering the study on concomitant oral corticosteroids, participant must be on a
             stable dose of prednisone (<= 10 mg/day), or oral corticosteroid equivalents, for at
             least 14 days prior to the Baseline visit.

          -  If entering the study on concomitant NSAIDs, tramadol, combination of acetaminophen
             and codeine or hydrocodone, and/or non-opioid analgesics, participant must be on
             stable dose(s) for at least 14 days prior to the Baseline visit.

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to
             tofacitinib, baricitinib, and filgotinib).

          -  Prior exposure to any biologic therapy with a potential therapeutic impact on
             spondyloarthritis (SpA).

          -  Intra-articular joint injections, spinal/paraspinal injection(s), or parenteral
             administration of corticosteroids within 28 days prior to the Baseline visit. Inhaled
             or topical corticosteroids are allowed.

          -  Participant on any other DMARDs (other than those allowed), thalidomide or apremilast
             within 28 days or five half-lives (whichever is longer) of the drug prior to the
             Baseline visit.

          -  Participant on opioid analgesics (except for combination acetaminophen/codeine or
             acetaminophen/hydrocodone which are allowed) or use of inhaled marijuana within 14
             days prior to the Baseline visit.

          -  Participant has a history of inflammatory arthritis of different etiology other than
             axial SpA (including but not limited to rheumatoid arthritis, psoriatic arthritis,
             mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis,
             scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset
             prior to 17 years of age.

          -  Laboratory values meeting the following criteria within the Screening period prior to
             the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal
             (ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by
             simplified 4-variable Modification of Diet in Renal Disease formula < 40 milliliter
             (mL)/minute/1.73m^2; hemoglobin < 10 gram/deciliter, total white blood cell count <
             2,500/microliter (μL); absolute neutrophil count < 1,500/μL; absolute lymphocyte count
             < 800/μL; and platelet count < 100,000/μL.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

AIHUA DU, M.D, 15671678920, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05303285

Organization ID

Tongji0228


Responsible Party

Principal Investigator

Study Sponsor

Tongji Hospital

Collaborators

 Wuhan Central Hospital

Study Sponsor

AIHUA DU, M.D, Study Chair, Tongji Hospital


Verification Date

March 2022