2022-502739-20-00招募中3 期
C0251006 - A PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06823859 IN PARTICIPANTS WITH ACTIVE IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH ACTIVE DERMATOMYOSITIS OR POLYMYOSITIS)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 77
- 试验地点
- 26
- 主要终点
- Cohort 1 (DM) - Global (except US): Moderate improvement in TIS at Week 24; Cohort 2 (PM) - Global (except US): Moderate improvement in TIS at Week 24
研究概览
简要总结
To evaluate the efficacy of dazukibart compared with placebo in reducing muscle symptoms in adult participants with active DM and adult participants with active PM.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult (aged ≥ 18 years old or minimum legal adult age as defined per local regulation, whichever is greater.
- •Definite or probable IIM as per ACR/EULAR Classification criteria of IIM with probability ≥55%, with confirmation of IIM subtypes: DM based on age at onset of first symptoms (DM ≥18 years) AND two of the following: Gottron’s papules; Gottron’s sign; Heliotrope eruption; Serology with at least 1 positive of the following TIF1-ƴ/P155, NXP2/P140, Mi2, MDA5, SAE 1 and/or 2, JO-1, PL-12, PL-7, EJ, or OJ. PM, age of onset of first symptoms ≥18 years AND the following: Absence of pathognomonic skin manifestations characteristic of DM (Gottron’s papules, Gottron’s sign, and Heliotrope rash), Muscle weakness pattern characteristic of myositis (eg, symmetric muscle weakness of the proximal upper/lower extremities; or neck flexors are relatively weaker than neck extensors; or in the legs proximal muscles are weaker than distal muscles), With EITHER of the following: Serology with at least 1 positive anti-synthetase autoantibodies (JO-1, PL-12, PL-7, EJ, OJ), OR Evidence of muscle biopsy confirming PM diagnosis.
- •Activity disease that fulfills the following criteria:
- •MMT-8 score ≤141 (out of 150 total possible).
- •At least 2 of the following abnormal CSM as a numerical scale (derived from VAS, where applicable) and/or objective measures of active muscle disease: • Patient global activity ≥2-points; • Physician’s global disease activity ≥2-points; • Extra-muscular activity (MDAAT) ≥2-points; • HAQ-DI ≥0.
- •At least 1 muscle enzyme >1.3 ×ULN, a magnetic resonance imaging (MRI) report within 12 weeks prior to Screening confirming active muscle disease (eg, findings of edema in skeletal muscle suggested by increased signal on T2 and short tau inversion recovery (STIR) sequences or by gadolinium enhancement), OR a muscle biopsy report within 12 weeks prior to Screening indicating inflammatory cell infiltration or elevated expression of inflammatory proteins, including but not limited to, human myxovirus resistance protein 1 (MxA) and major histocompatibility complex class I (MHC I), due to underlying DM or PM and the absence of rimmed vacuoles or necrotic fibers which may be pathognomonic of inclusion body myositis (IBM) and immune-mediated necrotizing myositis (IMNM).
- •Must be receiving a stable dose of SOC background medications at the time of enrollment, defined as a stable dose of: (1) 1 oral corticosteroid, or (2) 1 immunosuppressant, or (3) a combination of 1 oral corticosteroid and 1 immunosuppressant as background therapy. For example, a participant who may be receiving only 1 immunosuppressant may have a contraindication or intolerance, or has had an inadequate response to corticosteroids prescribed to control disease.
排除标准
- •Medical conditions pertaining to DM or PM: • Myositis due to non-IIM. • Existing diagnosis of IBM. • IMNM, including presence of positive anti-SRP and anti-HMGCR antibody confirmed by medical history. • Myositis with end-stage organ involvement at Screening or Visit
- •Inability to walk or bound to a wheelchair. Requiring oxygen supplementation at the time of screening.
结局指标
主要结局
Cohort 1 (DM) - Global (except US): Moderate improvement in TIS at Week 24; Cohort 2 (PM) - Global (except US): Moderate improvement in TIS at Week 24
Cohort 1 (DM) - Global (except US): Moderate improvement in TIS at Week 24; Cohort 2 (PM) - Global (except US): Moderate improvement in TIS at Week 24
次要结局
- Cohort 1 (DM): Global (except US) Change from baseline in MMT-8 score at Week 24. Change from baseline in Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score (CDASI-A) at Week 24 for participants with baseline CDASI-A score ≥14. Normalized area under the dose-time curve (AUC) of corticosteroid dose over 52 weeks. Moderate improvement in TIS at Week 52.
- Cohort 1 (DM): Global (except US): Change from baseline in PROMIS-PF at week 24. Change from baseline in 5-D Itch Scale Score at Week 24 for participants with baseline CDASI-A score ≥14. Change from baseline in FACIT-F score at Week 24.
- Cohort 2 (PM): Global (except US) Change from baseline in MMT-8 score at Week 24. Normalized AUC of corticosteroid dose over 52 weeks. Moderate improvement in TIS at Week 52. Change from baseline in PROMIS-PF at Week 24. Change from baseline in FACIT-F score at Week 24.
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (26)
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