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 Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients who provided written informed consent and who are able to complete study procedures. 2. Patients who are at least 18 years of age at time of screening. 3. Patients with PASI score of at least 12 at screening and at baseline. 4. Patients with involved body surface area of at least 10% at screening and at baseline. 5. 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. 6. Patients who are candidates for systemic therapy or phototherapy. 7. Previous failure, inadequate response in the opinion of the investigator, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy. 8. For female patients (except those at least 2 years postmenopausal or surgically sterilised): a negative serum pregnancy test at screening and at baseline. 9. 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. 10. 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:

1. 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. 2. Patients who have received any topical psoriasis treatment including corticosteroids. 3. Patients who have received the following treatments for psoriasis: 1. PUVA phototherapy and/or ultraviolet B phototherapy and/or laser therapy 2. Non-biologic psoriasis systemic therapies, tofacitinib, or apremilast 3. Adalimumab 4. Etanercept or secukinumab 5. Infliximab, brodalumab, certolizumab pegol, ixekizumab, golimumab, or alefacept 4. Patients taking drugs that may cause new onset or exacerbation of psoriasis 5. Patients who have received ustekinumab or any biologics directly targeting interleukin (IL) 12 or IL 23. 6. Patients with active infection or history of infections as follows: 1. Any active infection for which systemic anti-infectives were used within 4 weeks prior to randomisation 2. A serious infection, defined as requiring hospitalisation or intravenous anti-infectives, within 8 weeks prior to randomisation 3. Evidence of any clinically relevant bacterial, viral, fungal, or parasitic infection 4. 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04595409
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bioeq GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Official
Principal Investigator Affiliation Bioeq GmbH
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Poland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Arms & Interventions

Arms

Experimental: FYB202 (Proposed ustekinumab biosimilar)

Patients will receive subcutaneous injections of FYB202 as detailed in the protocol.

Active Comparator: Stelara® (Ustekinumab)

Patients will receive subcutaneous injections of Stelara® as detailed in the protocol.

Interventions

Drug: - FYB202 (Proposed ustekinumab biosimilar)

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.

Drug: - Stelara® (Ustekinumab)

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.

Contact a Trial Team

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International Sites

Research Site, Białystok, Poland

Status

Recruiting

Address

Research Site

Białystok, ,

Research Site, Toruń, Poland

Status

Recruiting

Address

Research Site

Toruń, ,

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