CompletedPhase 3

Efficacy, Safety, and Immunogenicity of AVT04 With Moderate-to-Severe Chronic Plaque Psoriasis

Estonia, Georgia581 participantsStarted 2021-06-03

Plain-language summary

Safety and Efficacy study of AVT04 (Alvotech Biosimilar to Ustekinumab), in patients with moderate to severe plaque psoriasis

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient has signed the informed consent form (ICF) and documentation as required by relevant competent authorities and is able to understand and adhere to the visit schedule and study requirements.
✓. Chinese patients shall be recruited in Mainland China.
✓. Patient is male or female, aged 18 to 75 years old, inclusive, at time of Screening.
✓. Patient weighs ≤100 kg at Screening and at BL.
✓. Patient has had moderate to severe chronic PsO for at least 6 months.
✓. Patient has involved body surface area (BSA) ≥10%, PASI ≥12, and 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) prior to Screening.
✓. Patient is a candidate for systemic therapy because the patient has had 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).

✕. Patient diagnosed with psoriatic arthritis, 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 visit (except low- to mid-potency topical corticosteroids on face, eyes, scalp, palms, soles, and genital area; only).
✕. 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 systemic steroid in the 4 weeks prior to the BL visit.
✕. Any oral traditional Chinese medicine (TCM) 4 weeks prior to the BL visit or any topical TCM 2 weeks prior to the BL visit.
✕. Investigational agent(s) within 90 days or 5 half-lives (whichever is longer) before BL visit.

Psoriasis Area and Severity Index (PASI)

Timeframe: Baseline to week 12

NCT IDNCT04930042

SponsorAlvotech Swiss AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-28

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient has signed the informed consent form (ICF) and documentation as required by relevant competent authorities and is able to understand and adhere to the visit schedule and study requirements.
✓. Chinese patients shall be recruited in Mainland China.
✓. Patient is male or female, aged 18 to 75 years old, inclusive, at time of Screening.
✓. Patient weighs ≤100 kg at Screening and at BL.
✓. Patient has had moderate to severe chronic PsO for at least 6 months.
✓. Patient has involved body surface area (BSA) ≥10%, PASI ≥12, and 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) prior to Screening.
✓. Patient is a candidate for systemic therapy because the patient has had 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).

✕. Patient diagnosed with psoriatic arthritis, 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 visit (except low- to mid-potency topical corticosteroids on face, eyes, scalp, palms, soles, and genital area; only).
✕. 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 systemic steroid in the 4 weeks prior to the BL visit.
✕. Any oral traditional Chinese medicine (TCM) 4 weeks prior to the BL visit or any topical TCM 2 weeks prior to the BL visit.
✕. Investigational agent(s) within 90 days or 5 half-lives (whichever is longer) before BL visit.