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

Momenta Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Psoriasis; Chronic Plaque Psoriasis

Treatments: Biological: Humira; Biological: M923

Study type: Interventional

Funder types: Industry

Identifiers

NCT02581345

911401

Details and patient eligibility

About

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.

Enrollment: 572 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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572 participants in 3 patient groups

M923

Experimental group

Description:

Participants assigned to receive M923

Treatment:

Biological: M923

Humira

Active Comparator group

Description:

Participants assigned to receive Humira

Treatment:

Biological: Humira

M923 and Humira

Other group

Description:

Participants assigned to receive M923 and Humira

Treatment:

Biological: M923

Biological: Humira