Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis
Condition: Chronic Plaque Psoriasis; Psoriasis
MeSH terms: Psoriasis
Intervention: M923; Humira
Intervention description: Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α); Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 572.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate to severe chronic plaque psoriasis; Psoriasis

Summary:

      The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed
      adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic
      plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be able to understand and communicate with the investigator and comply with the
             requirements of the study

          2. Chronic plaque-type psoriasis diagnosed for at least 6 months before screening

          3. Stable plaque psoriasis

          4. History of receipt of or candidate for therapy.

          5. Moderate to severe psoriasis at screening and baseline

          6. Must be willing and able to self-administer SC injections or have a caregiver
             available to administer injections

          7. Male participants of childbearing potential must employ a highly effective
             contraceptive measure

          8. Female participants must have a negative pregnancy test; are not planning to become
             pregnant; and must not be lactating. Female participants must also agree to employ a
             highly effective contraceptive measure.

        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