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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат Secukinumab 300mg s.c.
  Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 300 mg secukinumab s.c. every 4 weeks
• Препарат Secukinumab 150mg s.c.
  Induction: 5 x 150 mg secukinumab s.c. weekly. Maintenance: 150 mg secukinumab s.c. every 4 weeks

Первичные конечные точки

• Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 [Срок оценки: 24 weeks]

Вторичные конечные точки (12)

• Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 48 [Срок оценки: Baseline and Week 48]
• Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 48 [Срок оценки: Baseline and Week 48]
• Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 48 [Срок оценки: Baseline and Week 48]
• Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score [Срок оценки: Baseline and Week 48]
• Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission [Срок оценки: Baseline and Week 48]
• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 48 [Срок оценки: Baseline and Week 48]
• Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 48 [Срок оценки: Baseline and Week 48]
• Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 48 [Срок оценки: Baseline and Week 48]
• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment at Week 48 [Срок оценки: Baseline and Week 48]
• Change From Baseline in ASAS Health Index (HI) at Week 48 [Срок оценки: Baseline and Week 48]
• Percentage of Participants Achieving an ASAS 20 Response at Week 48 [Срок оценки: Baseline and Week 48]
• Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 48 [Срок оценки: Baseline and Week 48]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Department of RheumatologyTongji Hospital — Ухань
• Tongji Hospital — Ухань
• Tongji Hospital — Ухань

Идентификаторы

NCT: NCT05303285 · Tongji0228

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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