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)

You may be able to join if

• 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: 1. MMT-8 score ≤141 (out of 150 total possible). 2. 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 ≥0.25. 3. 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.