A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2A, Proof-Of-Concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 7
- 主要终点
- Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment
研究概览
简要总结
The purpose of the study is to evaluate efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome (FMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participant must be ≥18 years and ≤70 years of age at the time of signing the informed consent form (ICF)
- •Study participant with a diagnosis of fibromyalgia as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary
- •Diagnostic Criteria) plus the following characteristics during the Screening Period:
- •Brief Pain Inventory-short form (BPI-SF) interference score ≥
- •Study participant has been diagnosed with fibromyalgia syndrome (FMS) for at least 6 months.
- •Study participant has been having FMS symptomatology for at least 2 years before enrollment - Capable of giving signed informed consent as described in the Protocol which includes compliance with the requirements and restrictions listed in the ICF and in the Study Protocol
排除标准
- •Study participant has been diagnosed with fibromyalgia syndrome (FMS) for >15 years
- •Study participant has any systemic autoimmune inflammatory disease
- •Study participant has any medical or psychiatric or separate chronic pain condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study or the ability to assess FMS-related pain
- •Study participant has severe renal impairment, defined as estimated glomerular filtration rate <30 mL/min/1.73 m^2, (calculated using Modification of Diet in Renal Disease [MDRD] study equation), at Screening visit
- •Study participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator
- •Study participant has chronic inflammatory demyelinating polyneuropathy
- •Study participant has a current or medical history of primary immunodeficiency
- •Study participant is pregnant or lactating
- •Study participant
- •Has suicide attempt in the past 2 years (including an active attempt, interrupted attempt, or aborted attempt),
- •OR had suicidal ideation with at least some intent to act in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or Baseline (Visit 3);
- •OR is otherwise judged clinically to be at a serious suicidal risk based on the investigator's judgment
研究组 & 干预措施
Treatment sequence 1
Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
干预措施: rozanolixizumab (Drug)
Treatment sequence 1
Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
干预措施: Placebo (Other)
Treatment sequence 2
Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
干预措施: rozanolixizumab (Drug)
Treatment sequence 2
Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.
干预措施: Placebo (Other)
Treatment sequence 3
Study participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.
干预措施: Placebo (Other)
结局指标
主要结局
Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment
时间窗: At 12 weeks of treatment
The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study(From Baseline till end of Safety Follow-up (up to Week 33))
- Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment(At 12 weeks of treatment)
- Mean 7-day Fatigue Score Assessed With Fatigue Numeric Rating Scale at 12 Weeks of Treatment(At 12 weeks of treatment)
- Number of Participants With TEAEs Leading to Withdrawal of IMP(From Baseline till end of Safety Follow-up (up to Week 33))
- Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 24 Weeks of Treatment(At 24 weeks of treatment)
- Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment(At 12 Weeks of treatment)