Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis

Exclusion Criteria

• •1. Forms of psoriasis other than chronic plaque-type
• •2. Drug-induced psoriasis.
• •3. Other skin conditions which would interfere with assessment of psoriasis
• •4. Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening
• •5. Other inflammatory conditions other than psoriasis or psoriatic arthritis
• •6. Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies
• •7. Ongoing use of prohibited psoriasis treatments
• •8. Ongoing use of other non-psoriasis prohibited treatments
• •9. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks
• •10. Laboratory abnormalities at screening deemed clinically significant by the investigator
• •11. Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk
• •12. History of latex allergy
• •13. History of or current signs or symptoms or diagnosis of a demyelinating disorder
• •14. History of or current Class III or IV New York Heart Association congestive heart failure
• •15. Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
• •16. Current malignancy or history of any malignancy except adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ; no more than 3 lifetime basal cell and squamous cell carcinomas permitted
• •17. Chronic infections, recurrent infections; recent infection to be evaluated
• •18. History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or C virus (HCV)
• •19. History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
• •20. Exposure to an investigational product ≤30 days prior to enrollment or participation in another clinical study during the course of this study
• •21. Participant is a family member or employee of the investigator or site staff or study team