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

Completed · Phase 3

Conditions studied: Chronic Plaque Psoriasis, Psoriasis

In brief

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.

Key facts

Study ID

NCT02581345

Run by

Momenta Pharmaceuticals, Inc.

People needed

572

Starts

2015-09-01

Expected to finish

2017-04-04

Last updated by the study team

2018-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be able to understand and communicate with the investigator and comply with the requirements of the study
• Chronic plaque-type psoriasis diagnosed for at least 6 months before screening
• Stable plaque psoriasis
• History of receipt of or candidate for therapy.
• Moderate to severe psoriasis at screening and baseline
• Must be willing and able to self-administer SC injections or have a caregiver available to administer injections
• Male participants of childbearing potential must employ a highly effective contraceptive measure
• 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.

You may not qualify if…

• Forms of psoriasis other than chronic plaque-type
• Drug-induced psoriasis.
• Other skin conditions which would interfere with assessment of psoriasis
• Medical conditions other than psoriasis for which systemic corticosteroids were used in the last year prior to screening
• Other inflammatory conditions other than psoriasis or psoriatic arthritis
• Prior use of systemic tumor necrosis factor (TNF) inhibitors, or 2 or more non-TNF biologic therapies
• Ongoing use of prohibited psoriasis treatments
• Ongoing use of other non-psoriasis prohibited treatments
• All other prior non-psoriasis concomitant treatments must be on a stable dose for at least 4 weeks
• Laboratory abnormalities at screening deemed clinically significant by the investigator
• Any condition or illness which in the opinion of the investigator or sponsor poses an unacceptable safety risk
• History of latex allergy
• History of or current signs or symptoms or diagnosis of a demyelinating disorder
• History of or current Class III or IV New York Heart Association congestive heart failure
• Signs, symptoms, or diagnosis of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
• 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
• Chronic infections, recurrent infections; recent infection to be evaluated
• History of or presence of human immunodeficiency virus (HIV), or Hepatitis B (HBV) or C virus (HCV)
• History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
• Exposure to an investigational product ≤30 days prior to enrollment or participation in another clinical study during the course of this study
• Participant is a family member or employee of the investigator or site staff or study team

Where it is running

• Encino Research Center — Encino, California, United States
• eStudySite — La Mesa, California, United States
• eStudySite — Oceanside, California, United States
• eStudySite — San Diego, California, United States
• Shahram Jacobs MD, INC — Sherman Oaks, California, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Bioclinical Research Alliance; Inc — Miami, Florida, United States
• Sanitas Reasearch, LLC — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Radiant Research; Inc. — Overland Park, Kansas, United States
• Tufts Medical Center; Inc. — Boston, Massachusetts, United States
• Bay State Clinical Trials, Inc — Watertown, Massachusetts, United States
• eStudySite — Las Vegas, Nevada, United States
• Radiant Research; Inc. — Cincinnati, Ohio, United States
• Radiant Research, Inc. — Columbus, Ohio, United States
• Radiant Clinical Research — Anderson, South Carolina, United States
• Palmetto Clinical Trial Services, LLC — Fountain Inn, South Carolina, United States
• Radiant Research, Inc. — Greer, South Carolina, United States
• Austin Institute for Clinical Research, LLC — Pflugerville, Texas, United States
• Clinical Trials of Texas; Inc. — San Antonio, Texas, United States
• National Clinical Research-Richmond, Inc — Richmond, Virginia, United States
• Medical Centre Asklepii, OOD — Dupnitsa, Bulgaria
• Wallace Medical Group, Inc. — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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