Chronic Plaque Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Sponsors
Alvotech Swiss AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient has signed the Informed Consent Form (ICF) and is able to understand and adhere to the visit schedule and study requirements. 2.Patient is male or female, 18 to 75 years of age, inclusive, at time of Screening. 3.Patient 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 BL. 4.Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee). 5.Patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB). 6.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: •No evidence of active TB on chest radiograph within 3 months prior to the first dose of study drug. •Documented history of adequate prophylaxis initiation prior to receiving study drug in accordance with local recommendations. •No known exposure to active TB after most recent prophylaxis. •Asymptomatic at Screening and BL. Investigators should check with the medical monitor before enrolling such subjects. 7.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 BL. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1.Patient has prior use of 2 or more biologics for treatment of PsO 2.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 drug on psoriasis 3.Patient has prior use of any of the following medications within specified time periods or will require use during the study: a)Topical medications within 2 weeks of BL (Week 1) b)PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit c)Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the BL Visit d)Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational e)Any systemic steroid in the 4 weeks prior to BL. Specified washout periods are as follows: 1.Investigational agent(s) within 90 days or 5 half-lives (whichever is longer) before BL (Week 1) (Refer to Table 1 for approved/marketed products) 4.Patient has received live or attenuated vaccines during the 4 weeks prior to Randomization or has the intention of receiving a live or attenuated vaccine at any time during the study. Patients who test positive for TB must be treated for 1 month prior to taking part in the study. Investigators should check with the medical monitor before enrolling patients receiving active treatment for TB 5.Patient has any concurrent condition which, in the opinion of the Investigator, significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy 6.Patient 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 patient at further risk or hinder the patient’s ability to maintain compliance with study drug and the visit schedule 7.Patient has an active and serious infection or history of infections as follows: a)Any active infection 1)For which nonsystemic anti-infectives were used within 4 weeks prior to Randomization. Note: Patients receiving topical antibiotics for facial acne do not need to be excluded 2)Which required hospitalization or systemic anti-infective within 8 weeks prior to Randomization b)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 patient c)Invasive fungal infection or mycobacterial infection d)Opportunistic infections, such as listeriosis, legionellosis, or pneumocystis. 8.Patient is positive for human immunodeficiency virus, hepatitis C virus antibody, hepatitis B surface antigen (HBsAg) or hepatitis B core antibody 9.Patient has severe progressive or uncontrolled, clinically significant disease that in the judgment of the Investigator renders the patient unsuitable for the study 10.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 11.Patient 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 12.Patient has moderate-to-sever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the equivalence by Psoriasis Area and Severity Index (PASI) of AVT02 to EU-approved Humira with regards to efficacy at Week 16 in patients with moderate-to-severe chronic plaque psoriasis;Secondary Objective: Secondary Objectives: • To compare the efficacy of AVT02 and EU-approved Humira in patients with moderate-to-severe chronic plaque psoriasis at Visits 8, 12, 16, 24, 32, 42, and 50 • To compare steady-state pharmacokinetics of AVT02 and EU approved Humira • To compare the safety, tolerability, and immunogenicity of AVT02 and EU-approved Humira at Weeks 16, 24, 32, 42, and 50 Exploratory Objectives: • To compare the efficacy of AVT02 and EU-approved Humira in patients with psoriatic arthritis (PsA) at Week 12 • Change from Baseline (BL) in Routine Assessment of Patient Index Data 3 (RAPID3) at Week 12 (only for PsA) • To assess ex-vivo immunogenicity by T-cell proliferation and cytokine production in a subset of patients at Weeks 1, 8, and 16 ;Primary end point(s): •Percent improvement in Psoriasis Area and Severity Index (PASI) from BL to Week 16;Timepoint(s) of evaluation of this end point: 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50 •PASI 50, PASI 75, PASI 90, and PASI 100 response rate at Weeks 16, 24, and 50 •Number and percentage of patients achieving sPGA responses of clear (0) or almost clear (1) at Weeks 16, 24, and 50 •Change from BL in quality of life as measured by Dermatology Life Quality Index (DLQI) scores at Weeks 16, 24, and 50 ;Timepoint(s) of evaluation of this end point: 50 weeks | — |
Countries
Estonia, Georgia, Poland, Russian Federation, Ukraine
Contacts
Public ContactFausto Berti
Alvotech Swiss AG
Outcome results
None listed