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

NCT ID: NCT04595409

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2022-03-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FYB202 (Proposed ustekinumab biosimilar)

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

Group Type: EXPERIMENTAL

FYB202 (Proposed ustekinumab biosimilar)

Intervention Type: 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.

Stelara® (Ustekinumab)

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

Group Type: ACTIVE_COMPARATOR

Stelara® (Ustekinumab)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioeq GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Official

Role: STUDY_DIRECTOR

Bioeq GmbH

Locations

Research Site

Tallinn, , Estonia

Research Site

Tartu, , Estonia

Research Site

Tbilisi, , Georgia

Research Site

Bialystok, , Poland

Research Site

Gdansk, , Poland

Research Site

Krakow, , Poland

Research Site

Lodz, , Poland

Research Site

Olsztyn, , Poland

Research Site

Torun, , Poland

Research Site

Warsaw, , Poland

Research Site

Wroclaw, , Poland

Research Site

Dnipro, , Ukraine

Research Site

Kharkiv, , Ukraine

Research Site

Kyiv, , Ukraine

Research Site

Rivne, , Ukraine

Research Site

Zaporizhzhya, , Ukraine

Countries

Estonia; Georgia; Poland; Ukraine

References

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.

Reference Type: DERIVED

PMID: 40048101 (View on PubMed)

Other Identifiers

FYB202-03-01

Identifier Type: -

Identifier Source: org_study_id