| Study name |
Efficacy, safety, and immunogenicity of AVT02 with moderate‐to‐severe chronic plaque psoriasis |
| Methods |
Phase 3
RCT, active‐controlled, double‐blind
Date of study: February 2019
Location: Poland, Estonia, Georgia, Ukraine |
| Participants |
Randomised: 413
Inclusion criteria
Patient with moderate‐to‐severe chronic plaque psoriasis Patient has had stable psoriatic disease for at least 2 months 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 criteria
Patient has prior use of 2 or more biologics for treatment of PsO 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 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 (e.g., 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
|
| Interventions |
Intervention
AVT02 (adalimumab biosimilar) 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) until week 48
Control intervention
Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW until week 48 |
| Outcomes |
Primary outcome measures :
Psoriasis Area and Severity Index (PASI) [ Time Frame: baseline to week 16 ]
Percent (%) change in PASI
Secondary outcome measures:
PASI [ Time frame: Percent improvement in PASI from BL to week 8, 12, 24, 32, 42, and 50 ]
Percent (%) change in PASI |
| Starting date |
Study start date: February 2019
Actual study completion date: July 2020
Last update posted: July 2020, completed |
| Contact information |
Investigator: Steve Feldman, MD PhD, Wake Forest University Health Sciences |
| Notes |
NCT03849404 funding: Alvotech Swiss AG (Alvotech) |
