| Participants |
Randomised: 294 participants
Inclusion criteria
Has signed the informed consent form Is aged 18 to 75 years, inclusive, at time of screening Has had moderate‐to‐severe chronic plaque psoriasis for at least 6 months Has involved BSA ≥ 10%, PASI ≥ 12, and sPGA ≥ 3 (moderate) at screening and at baseline Has had stable disease for at least 2 months (i.e. without significant changes as defined by the investigator) Is a candidate for systemic therapy Has had a previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy Is naïve to adalimumab therapy, approved or investigational For women of childbearing potential, a negative serum pregnancy test during screening and a negative urine pregnancy test at baseline
Exclusion criteria
Diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication‐induced psoriasis, other skin conditions (e.g. eczema), or other systemic autoimmune disorder inflammatory disease at the time of the screening visit that would interfere with evaluations of the effect of the study treatment on psoriasis -
Has used any of the following medications within specified time periods or will require their use during the study:
Topical medications within 2 weeks before the end of the screening period oral psoralen with ultraviolet A (PUVA) phototherapy and/or ultraviolet B (UVB) phototherapy within 4 weeks before the end of the screening period; Nonbiologic systemic therapies within 4 weeks before the end of the screening period (e.g. cyclosporine, methotrexate, and acitretin); Any prior or concomitant adalimumab therapy, approved or investigational; Any other investigational agent within 90 days or 5 half‐lives of screening (whichever is longer); Any systemic steroid in the 4 weeks before the end of the screening period Note: Low‐potency topical corticosteroids applied to the palms, soles, face, and intertriginous areas are permitted during study participation
Has received live vaccines during the 4 weeks prior to screening or has the intention of receiving a live vaccine at any time during the study Has a positive test for tuberculosis (TB) during screening or a known history of active or latent TB, except documented and complete adequate treatment of TB or initiation (> 1 month) of adequate prophylaxis of latent TB, with an isoniazid‐based regimen. Patients with a positive purified protein derivative (PPD) and a history of Bacillus Calmette‐Guérin vaccination are allowed with a negative Interferon‐γ release assays (IGRA)Patients with a positive PPD test without a history of Bacillus Calmette‐Guérin vaccination or those with a positive or indeterminate IGRA are allowed if they have all of the following: No symptoms or signs of active TB, including a negative chest x‐ray within 3 months prior to the first dose of study treatment; Documented history of completion of adequate treatment of TB or initiation (> 1 month) of adequate prophylaxis of latent TB, with an isoniazid‐based regimen prior to receiving study treatment in accordance with local recommendations Underlying condition (including, but not limited to metabolic, haematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal) which, in the opinion of the investigator, significantly immunocompromises the person and/or places them at unacceptable risk for receiving an immunomodulatory therapy Has a planned surgical intervention during the duration of the study except those related to the underlying disease and which, in the opinion of the investigator, will not put the person at further risk or hinder their ability to maintain compliance with study treatment and the visit schedule -
Has an active and serious infection or history of infections as follows:
Any active infection for which nonsystemic anti‐infectives were used within 4 weeks prior to randomisation. Requiring hospitalisation or systemic anti‐infectives within 8 weeks prior to randomisation Recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the person Invasive fungal infection or mycobacterial infection Opportunistic infections, such as listeriosis, legionellosis, or pneumocystis
Is positive for HIV, hepatitis C virus antibody or hepatitis B surface antigen (HBsAg) or is positive for hepatitis B core antibody and negative for HBsAg at screening Has a history of clinically‐significant haematological abnormalities, including cytopenias (e.g. thrombocytopenia, leukopenia) Has severe progressive or uncontrolled, clinically‐significant disease that in the judgement of the investigator renders the person unsuitable for the study Has history of malignancy within 5 years, except adequately‐treated cutaneous squamous or basal cell carcinoma, in situ cervical cancer or in situ breast ductal carcinoma Has active neurological disease such as multiple sclerosis, Guillain‐Barré syndrome, optic neuritis, transverse myelitis, or history of neurologic symptoms suggestive of central nervous system demyelinating disease Has moderate‐to‐severe heart failure (New York Heart Association class III/IV) Has a history of hypersensitivity to the active substance or to any of the excipients of Humira® or MYL‐1401A Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a woman after conception and until the termination of gestation Evidence of alcohol or drug abuse or dependency at the time of screening, for the 5 years prior to screening or during the study Is unable to follow study instructions and comply with the protocol in the opinion of the investigator
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