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 (VESPUCCI)

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

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: FYB202 (Proposed ustekinumab biosimilar); Drug: Stelara® (Ustekinumab)

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Phase 3

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia
    • Research Site
  • Tartu, Estonia
    • Research Site
• Georgia
  • Tbilisi, Georgia
    • Research Site
• Poland
  • Białystok, Poland
    • Research Site
  • Gdańsk, Poland
    • Research Site
  • Kraków, Poland
    • Research Site
  • Olsztyn, Poland
    • Research Site
  • Toruń, Poland
    • Research Site
  • Warsaw, Poland
    • Research Site
  • Wrocław, Poland
    • Research Site
  • Łódź, Poland
    • Research Site
• Ukraine
  • Dnipro, Ukraine
    • Research Site
  • Kharkiv, Ukraine
    • Research Site
  • Kyiv, Ukraine
    • Research Site
  • Rivne, Ukraine
    • Research Site
  • Zaporizhzhya, Ukraine
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FYB202 (Proposed ustekinumab biosimilar); Patients will receive subcutaneous injections of FYB202 as detailed in the protocol.	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.
Active Comparator: Stelara® (Ustekinumab); Patients will receive subcutaneous injections of Stelara® as detailed in the protocol.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bioeq GmbH
• Investigators: Study Director: Study Official, Bioeq GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2020
• Primary Completion (Actual): June 7, 2021
• Study Completion (Actual): March 21, 2022

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: FYB202-03-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No