CTIS2022-502739-20-00招募中1 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) - C0251006
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 270
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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-?/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., Disease activity/severity fulfills the following criteria: 1. MMT-8 score =141 (out of 150 total possible). 2. At least 1 of the following abnormal CSM as a numerical scale (derived from VAS, where applicable): • Patient global activity =2-points; • Physician’s global disease activity =2-points; • Extra-muscular activity (MDAAT) =2-points; • HAQ-DI =0.25. 3. At least 1 muscle enzyme >1.5 ×ULN., 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 1. • Inability to walk or bound to a wheelchair. Requiring oxygen supplementation at the time of screening.
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