A Double-blind Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

Study Overview
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Brief Summary
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This is a randomized, double-blind, multicenter study to evaluate the efficacy, safety, and immunogenicity of FYB202 compared to Stelara® in patients with Moderate-to-Severe Plaque Psoriasis.

Official Title
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A Randomised, Double-blind, Parallel-group, Phase 3 Study to Compare the Efficacy, Safety, and Immunogenicity of the Proposed Biosimilar Ustekinumab FYB202 to Stelara® in Patients With Moderate-to-Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: FYB202 (Proposed ustekinumab biosimilar)
* Drug: Stelara® (Ustekinumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who provided written informed consent and who are able to complete study procedures. Patients who are at least 18 years of age at time of screening. Patients with PASI score of at least 12 at screening and at baseline. Patients with involved body surface area of at least 10% at screening and at baseline. Patients with a Physician's Global Assessment (PGA) score of at least 3 at screening and at baseline by means of a 5-point scoring scale. Patients who are candidates for systemic therapy or phototherapy. Previous failure, inadequate response in the opinion of the investigator, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy. For female patients (except those at least 2 years postmenopausal or surgically sterilised): a negative serum pregnancy test at screening and at baseline. Female patients of childbearing potential with a fertile male sexual partner must use adequate contraception from screening until 4 months after the last dose of study intervention. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device (IUD), combined with at least one of the following forms of contraception: a diaphragm, cervical cap, or a condom. Total abstinence from heterosexual activity, in accordance with the lifestyle of the patient, is acceptable. Female patients must not donate ova starting at screening and throughout the clinical study period and for 4 months after study intervention administration. Male patients who are sexually active with women of childbearing potential must agree they will use adequate contraception if not surgically sterilised and will not donate sperm from the time of screening until 6 months after the last dose of study intervention. Adequate contraception for the male patient and his female partner of childbearing potential is defined as using hormonal contraceptives or an IUD combined with at least one of the following forms of contraception: a diaphragm, cervical cap, or a condom. Total abstinence from heterosexual activity, in accordance with the lifestyle of the patient, is acceptable. Exclusion Criteria: Patients diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, any other skin disease, or other systemic inflammatory autoimmune disorder at the time of the screening and baseline visits that would interfere with evaluations of the effect of study intervention on psoriasis. Patients who have received any topical psoriasis treatment including corticosteroids. Patients who have received the following treatments for psoriasis: PUVA phototherapy and/or ultraviolet B phototherapy and/or laser therapy Non-biologic psoriasis systemic therapies, tofacitinib, or apremilast Adalimumab Etanercept or secukinumab Infliximab, brodalumab, certolizumab pegol, ixekizumab, golimumab, or alefacept Patients taking drugs that may cause new onset or exacerbation of psoriasis Patients who have received ustekinumab or any biologics directly targeting interleukin (IL) 12 or IL 23. Patients with active infection or history of infections as follows: Any active infection for which systemic anti-infectives were used within 4 weeks prior to randomisation A serious infection, defined as requiring hospitalisation or intravenous anti-infectives, within 8 weeks prior to randomisation Evidence of any clinically relevant bacterial, viral, fungal, or parasitic infection Recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FYB202 (Proposed ustekinumab biosimilar)<br>Patients will receive subcutaneous injections of FYB202 as detailed in the protocol. | Drug: FYB202 (Proposed ustekinumab biosimilar)<br>* Patients will receive 1 subcutaneous (SC) injection of FYB202 at week 0 and week 4, followed by 1 SC injection every 12 weeks thereafter for the next 3 consecutive doses.<br>|
| Active Comparator: Stelara® (Ustekinumab)<br>Patients will receive subcutaneous injections of Stelara® as detailed in the protocol. | Drug: Stelara® (Ustekinumab)<br>* Patients will receive 1 subcutaneous (SC) injection of Stelara® at week 0 and week 4, followed by 1 SC injection every 12 weeks thereafter for the next 3 consecutive doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent improvement in Psoriasis Area and Severity Index (PASI) score |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent improvement in PASI score |  | Through study completion, approximately 1 year | 
| Raw PASI score |  | Through study completion, approximately 1 year | 
| Proportion of patients with PASI 75 and PASI 90 |  | Through study completion, approximately 1 year | 
| Change per Physician's Global Assessment (PGA) |  | Through study completion, approximately 1 year | 
| Improvement of Dermatology Life Quality Index (DLQI) total score |  | Through study completion, approximately 1 year | 
| Itching Visual Analogue Scale |  | Through study completion, approximately 1 year | 
| Relative frequency, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) |  | Through study completion, approximately 1 year | 
| Serum trough levels of ustekinumab |  | Through study completion, approximately 1 year | 
| Number of patients with antibodies to ustekinumab |  | Through study completion, approximately 1 year |