Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis

Exclusion Criteria

• •1. Patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, 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 of psoriasis.
• •2. Patient has prior use of any of the following medications within specified time periods or will require use during the study:
• •1. Topical medications within 2 weeks of Baseline (Week 1/Day 1). PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the Baseline (Week 1/Day 1).
• •2. Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the Baseline (Week 1/Day 1).
• •3. Any prior or concomitant adalimumab therapy, either approved or investigational.
• •4. Any systemic steroid in the 4 weeks prior to Screening.
• •5. Investigational agent(s) within 90 days or 5 half-lives (whichever is longer) before Baseline (Week 1/Day 1) (Refer to the following table for approved/marketed products).
• •Specified washout periods are as follows:
• •* Adalimumab: not allowed
• •* Alefacept, Briakinumab, Brodalumab, Golimumab: 24 weeks
• •* Ustekinumab: 15 weeks
• •* Etanercept , Secukinumab , Infliximab , Certolizumab, Pegol: 12 weeks
• •* Cyclosporine: 4 weeks
• •* Methotrexate: 4 weeks
• •* PUVA-UVA/UVB: 4 weeks
• •* Oral retinoid: 4 weeks
• •* Corticosteroids IM - IV - oral - intra-articular for psoriatic arthritis: 4 weeks
• •* Topical psoriasis treatments (except in face, eyes, scalp, palms, soles, and genital area and except only mild potency steroids in these areas): 2 weeks
• •3. Patient has received live or attenuated vaccines during the 4 weeks prior to Screening or intends to receive a live or attenuated vaccine at any time during the study.
• •4. Patient has an underlying condition (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal) which, in the opinion of the Investigator or designee, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
• •5. Patient has a planned surgical intervention during the duration of the study and which, in the opinion of the Investigator or designee, will put the subject at further risk or hinder the patient's ability to maintain compliance with study treatment and the visit schedule.
• •6. Has any active and serious infection or history of infections as follows:
• •1. Any active infection:
• •* For which non-systemic anti-infective were used within 4 weeks prior to randomization. Note: patients receiving topical antibiotics for facial acne do not need to be excluded.
• •* Which required hospitalization or systemic anti-infective within 8 weeks prior to randomization.
• •2. Recurrent or chronic infections or other active infection that, in the opinion of the Investigator or designee, might cause this study to be detrimental to the subject.
• •3. Invasive fungal infection or mycobacterial infection.
• •4. Opportunistic infections, such as listeriosis, legionellosis, or pneumocystis.
• •7. Patient is positive for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B surface antigen (HBsAg) and/or is positive for hepatitis B core antibody.
• •8. Patient has severe progressive or uncontrolled, clinically significant disease that in the judgment of the Investigator or designee renders the subject unsuitable for the study.
• •9. Patient has a history of malignancy within 5 years except for adequately treated cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
• •10. Patient has an active neurological disease, such as multiple sclerosis, Guillain-Barré syndrome, optic neuritis, and transverse myelitis, or a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
• •11. Patient has moderate to severe heart failure (New York Heart Association \[NYHA\] Class III/IV).
• •12. Patient has a history of hypersensitivity to the active substance or to any of the excipients of Humira or AVT02.
• •13. Patient is pregnant or nursing (lactating) woman, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
• •14. Patient exhibits evidence (as assessed by the Investigator or designee using good clinical judgment) of active substance abuse (alcohol or drugs) within 6 months of Screening that may impact patient's ability to participate in the study.
• •15. Is unable to follow study instructions and comply with the protocol in the opinion of the Investigator or designee.
• •16. Patient has a history of clinically significant hematological abnormalities, including cytopenias (eg, thrombocytopenia, leukopenia).
• •17. Has a laboratory abnormality that, in the opinion of the Investigator or designee, could cause this study to be detrimental to the subject. The following laboratory abnormalities should be carefully considered:
• •1. Hemoglobin \< 9 g/dL.
• •2. Platelet count \< 100,000/mm3.
• •3. White blood cell count \< 3000 cells/mm3.
• •4. Aspartate aminotransferase and/or alanine aminotransferase that is persistently ≥ 2.5 × the upper limit of normal. (Persistently indicates at least on 2 occasions separated by a number of days).
• •5. Creatinine clearance \< 50 mL/min (Cockcroft-Gault formula).