| Eligibility |
Inclusion Criteria:
1. Patient has signed the informed consent form and documentation as required by relevant
competent authorities and is able to understand and adhere to the visit schedule and
study requirements.
2. Patient is male or female aged 18 to 75 years, inclusive, at the time of Screening.
3. Patients with moderate-to-severe chronic plaque psoriasis who has involved body
surface area (BSA) = 10% (Palm Method), = 12 on the PASI, and static Physicians Global
Assessments (sPGA) = 3 (moderate) at Screening and at Baseline (Week 1/Day 1).
4. Patient has had stable disease for at least 2 months (ie, without significant changes
as defined by the Investigator or designee).
5. Patients with moderate to severe chronic plaque psoriasis who are candidates for
systemic therapy or phototherapy, and when other systemic therapies are medically less
appropriate.
6. Patient is naive to adalimumab therapy, approved or investigational.
7. Patient has a negative QuantiFERON test for tuberculosis (TB) during Screening. Note:
Patients with an indeterminate QuantiFERON test are allowed if they have all of the
following:
1. No evidence of active TB on chest radiograph within 3 months prior to the first
dose of study drug.
2. Documented history of treatment of TB or adequate prophylaxis initiation with an
isoniazid-based regimen > 1 month prior to receiving study drug in accordance
with local recommendations.
3. No known exposure to active TB after most recent prophylaxis.
4. Asymptomatic at Screening and Baseline. Investigators should check with the
medical monitor before enrolling such subjects.
8. Women of childbearing potential (except those who are postmenopausal for more than 2
years or if surgically sterile) must have a negative serum pregnancy test during
Screening and negative urine pregnancy test at Baseline (Week 1/Day 1).
9. Sexually active women of childbearing potential must agree to use highly effective
contraception (sterilization, hormonal contraception pills or injection or implants,
sterilization and abstinence) for the duration of the study and until 6 months after
the last dose of the study drug. Male patients must agree to use contraception for the
duration of the study and agree not to donate sperm during and for 6 months after the
last dose of study drug.
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).
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