A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Ustekinumab (AVT04) and Stelara® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Phase 1

• Conditions: Moderate to Severe Chronic Plaque-type Psoriasis; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-004493-22-PL
• Lead Sponsor: Alvotech Swiss AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-29
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 528

Inclusion Criteria

1.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.
2.Patient is male or female, aged 18 to 75 years old, inclusive, at time of Screening.
3.Patient has had moderate to severe chronic PsO for at least 6 months.
4.Patient has involved body surface area =10%, PASI =12, and static Physician's Global Assessment (sPGA) =3 (moderate) at Screening and at BL.
5.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.
6.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).
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:
a.No evidence of active TB on chest radiograph within 3 months prior to the first dose of study drug.
b.Documented history of adequate prophylaxis initiation prior to receiving study drug in accordance with local recommendations.
c.No known exposure to active TB after most recent prophylaxis.
d.Asymptomatic at Screening and BL.
Investigators should check with the medical monitor before enrolling such patients.
8.Patient is naïve to ustekinumab therapy, approved or investigational.
9.Female patients are eligible to participate if they are NOT pregnant (with negative serum pregnancy test at Screening [refer to Appendix 14.5]), not breastfeeding, and at least ONE of the following conditions applies:
a.If a women of childbearing potential (WOCBP) -
i.agrees to use a highly effective method of contraception (Appendix 14.5) consistently and correctly from Screening (signing the ICF) until at least 15 weeks after investigational product (IP) administration or
ii.whose career, lifestyle, or sexual orientation precludes sexual intercourse with a male partner or
iii.having sexual intercourse exclusively with a sterile male partner
b.If not a WOCBP (non-WOCBP), defined as:
i.Surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the patient’s medical records, medical examination, or medical history interview), or
ii.Postmenopausal (defined as no menses for 12 months without an alternative medical cause). A high follicle stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy [HRT]. Female patients on HRT and whose menopausal status is in doubt will be required to use 1 of the non-estrogen hormonal highly effective contraception methods (refer to Appendix 14.5) from Screening (signing the ICF) until at least 15 weeks after IP administration if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment
Note: Nonsterilized male patients with female partners of childbearing potential are eligible to participate if they agree to ONE of the following from Screening (signing the ICF) until at least 15 weeks afte

Exclusion Criteria

1.Patient diagnosed with psoriatic arthritis,erythrodermic psoriasis,pustular psoriasis,guttate psoriasis,medication-induced psoriasis,other skin conditions,or other systemic autoimmune disorder at the time of the Screening Visit that would interfere with evaluations of the effect of the study drug on psoriasis.
2.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 visit (except low- to mid-potency topical corticosteroids on face,eyes,scalp,palms,soles,and genital area;only).
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 systemic steroid in the 4 weeks prior to the BL visit.
e.Investigational agent(s) within 90 days or 5 half-lives (whichever is longer) before BL visit.
f.Other systemic biologics within 90 days or 5 half lives (whichever is the longer) before BL visit.
g.Any therapeutic agent targeting interleukin (IL)-12, IL-17 or IL-23 at any time (eg, Secukinumab,Briakinumab,Guselkumab,Ixekizumab,and Brodalumab).
Refer to the protocol table in Exclusion criteria for specified washout periods for products listed.
3.Patient has received live or attenuated vaccines during the 4 weeks prior to BL visit or has the intention of receiving a live or attenuated vaccine during the study.
Note: Inactivated (non-live and non-attenuated) vaccines are allowed.
4.Patient has an underlying condition (including, but not limited to metabolic,hematologic,renal,hepatic,pulmonary,neurologic,endocrine,cardiac,infectious,or gastrointestinal) which significantly immunocompromises the patient and/or places the patient at unacceptable risk for receiving an immunomodulatory therapy.
5.Patient has a planned surgical intervention during the duration of the study except those related to the underlying disease and which will not put the patient at further risk or hinder the patient's ability to maintain compliance with study drug and the visit schedule.
6.Patient has an active infection or history of infections as follows:
a.Any active infection (including Severe Acute Respiratory Syndrome-Coronavirus-2 infection)
i.For which non-systemic anti-infectives were used within 4 weeks prior to BL visit.
Note: patients receiving topical antibiotics for facial acne do not need to be excluded.
ii.Which required hospitalization/quarantine or systemic anti-infective within 8 weeks prior to BL visit.
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.
7.Patient is positive for human immunodeficiency virus, hepatitis C virus antibody, hepatitis B surface antigen, and/or 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 patient 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 active neurological disease such as multiple sclerosis,Guillain-Barré

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified