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

NCT04595409 | Completed Phase 3

• 1 other identifier: FYB202-03-01
• Study Type: interventional
• Target: 392
• Locations: 4 countries
• Sites: 16

Brief Summary

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent improvement in Psoriasis Area and Severity Index (PASI) score

  Week 12

Secondary Outcomes (9)

• 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

Study Arms (2)

FYB202 (Proposed ustekinumab biosimilar)

EXPERIMENTAL

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

Drug: FYB202 (Proposed ustekinumab biosimilar)

Stelara® (Ustekinumab)

ACTIVE COMPARATOR

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

Drug: Stelara® (Ustekinumab)

Interventions

FYB202 (Proposed ustekinumab biosimilar) DRUG

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.

FYB202 (Proposed ustekinumab biosimilar)

Stelara® (Ustekinumab) DRUG

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.

Stelara® (Ustekinumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bioeq GmbH: lead

Study Sites (16)

Research Site

Tallinn, Estonia

Location

Research Site

Tartu, Estonia

Location

Research Site

Tbilisi, Georgia

Location

Research Site

Bialystok, Poland

Location

Research Site

Gdansk, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Olsztyn, Poland

Location

Research Site

Torun, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Wroclaw, Poland

Location

Research Site

Dnipro, Ukraine

Location

Research Site

Kharkiv, Ukraine

Location

Research Site

Kyiv, Ukraine

Location

Research Site

Rivne, Ukraine

Location

Research Site

Zaporizhzhya, Ukraine

Location

Related Publications (1)

• Papp K, Balser S, Nopora K, Rewerski P, Freudensprung B, Trieb M. A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis. Adv Ther. 2025 May;42(5):2135-2149. doi: 10.1007/s12325-025-03138-2. Epub 2025 Mar 6.

  PMID: 40048101 DERIVED

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Official

  Bioeq GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: November 9, 2020
• Primary Completion: June 7, 2021
• Study Completion: March 21, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); PL (8); UA (5); GE (1)