A Phase 2 proof of concept study to evaluate the efficacy and safety of daxdilimab in participants with dermatomyositis or anti-synthetase inflammatory myositis

You may be able to join if

• '- Adult men or women ≥ 18 and ≤ 75 years of age at the time of signing the ICF. - A diagnosis of definite or probable myositis according to ACR/EULAR 2017 criteria (A OR B): -A. Total aggregated score ≥ 5.5 without a muscle biopsy Note: Pathognomonic skin rash (heliotrope rash, Gottron’s papules and/or Gottron’s sign) is required if no muscle biopsy is available. -OR -B. Total aggregated score ≥ 6.7 with muscle biopsy Note: The local muscle biopsy report will be used in the ACR/EULAR 2017 criteria to determine participant eligibility. Submission of the historical biopsy sample (archived tissue block, physical slides, and/or digital pathology slides) or documentation of attempts to obtain results of historical biopsy is required for randomized participants. -AND (a or b) a. Population 1: DM • Diagnosis of DM with DM rash current or historical, -OR b. Population 2: ASIM • Anti-Jo-1 antibodies must be positive during Screening by central laboratory testing, or • One of following antibodies must be positive by historical testing: anti-PL-12,anti-PL-7, anti-KS, anti-EJ, anti-OJ, anti-ZO, anti-YRS(HA). Currently active myositis with all the following (a, b, and c) during Screening: a. MMT8 score < 142 b. At least 2 other abnormal CSM from the following list: • PtGDA ≥ 2cm in a 10 cm visual analog scale (VAS) • PhGDA ≥ 2cm in a 10 cm VAS • Extramuscular activity ≥ 2cm in a 10 cm VAS • At least one muscle enzyme 1.5 times upper limit of normal (ULN) • HAQ-DI ≥0.5 Global muscle damage score 5 on a 10 cm VAS on the MDI. Participants should be on stable standard of care therapy if tolerated (a); if they are not able to tolerate it or have failed standard of care, medications should have washed out • (b): Participants on corticosteroid treatment (up to 20 mg prednisone or equivalent per • day) and/or up to 2, non-excluded, immunosuppressants on stable therapy for at least 4 weeks prior to Randomization or • Participants with previous failure of response or previous intolerance to corticosteroid and at least 1 additional immunosuppressant drug, and with steroid/immunosuppressants washed out. Participants should be willing to taper corticosteroid dose per protocol when stable or improving. For detailed inclusion criteria, refer to the protocol, Summary of changes (Pages 3-15)