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A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous

Rheumatology, Neurology
Ali Habib
A Phase 4, Open-Label, Prospective, Single-Group, Multicenter Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adult Participants With New-Onset Generalized Myasthenia Gravis
Brain - Neurologic/ Psychologic
Lupus Erythematosus
Neuromuscular Diseases

Study Description

The total study duration per participant is approximately 61 weeks.

Eligibility

  1. Have documented diagnosis of SCLE or CCLE that has been confirmed by biopsy with or without systemic LE manifestations.
  2. Have a total CLASI-A score of greater than or equal to 10 at Screening and Day 1. Participants with a CLASI-A score of greater than or equal to 8 and less than 10 are eligible if the score does not include alopecia and/or mucous membrane lesions.
  3. Have active CLE despite an adequate trial of conventional therapies.
  4. Are positive for at least one autoantibody at Screening.
  1. Have known or suspected drug-induced CLE anti-phospholipid disease, or neuropsychiatric SLE.
  2. Have rapidly progressive nephritis.
  3. Have current inflammatory skin disease other than SCLE/CCLE that, in the opinion of the Investigator, could interfere with the inflammatory skin assessments or confound the disease activity assessments.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

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