Status:
COMPLETED
Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis
Lead Sponsor:
Alvotech Swiss AG
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.
Detailed Description
A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Pl...
Eligibility Criteria
Inclusion
- 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.
- Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
- 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).
Exclusion
- Patient has prior use of 2 or more biologics for treatment of PsO.
- 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.
- Patient has prior use of any of the following medications within specified time periods or will require use during the study:
- Topical medications within 2 weeks of BL (Week 1).
- PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit.
- Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the BL Visit.
- Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational.
- Any systemic steroid in the 4 weeks prior to BL.
- Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened and randomized per the list in the protocol
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2020
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT03849404
Start Date
February 20 2019
End Date
July 20 2020
Last Update
July 28 2020
Active Locations (20)
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1
Innomedica OU
Tallinn, Estonia, 10117
2
OU Vahlberg & Pild
Tallinn, Estonia, 10134
3
North Estonia Medical Centre Foundation, Dermatovenerology Centre
Tallinn, Estonia, 13419
4
Tartu University Hospital, Dermatology Clinic
Tartu, Estonia, 50406