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