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

Plaque Psoriasis Clinical Trial

— VESPUCCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595409
• Other study ID #: FYB202-03-01
• Status: Completed
• Phase: Phase 3
• Start date: November 9, 2020
• Est. completion date: March 21, 2022

Study information

• Verified date: February 2023
• Source: Bioeq GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: March 21, 2022
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Georgia	Research Site	Tbilisi
Poland	Research Site	Bialystok
Poland	Research Site	Gdansk
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Olsztyn
Poland	Research Site	Torun
Poland	Research Site	Warsaw
Poland	Research Site	Wroclaw
Ukraine	Research Site	Dnipro
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Rivne
Ukraine	Research Site	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Bioeq GmbH

Countries where clinical trial is conducted

Estonia,  Georgia,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent improvement in Psoriasis Area and Severity Index (PASI) score		Week 12
Secondary	Percent improvement in PASI score		Through study completion, approximately 1 year
Secondary	Raw PASI score		Through study completion, approximately 1 year
Secondary	Proportion of patients with PASI 75 and PASI 90		Through study completion, approximately 1 year
Secondary	Change per Physician's Global Assessment (PGA)		Through study completion, approximately 1 year
Secondary	Improvement of Dermatology Life Quality Index (DLQI) total score		Through study completion, approximately 1 year
Secondary	Itching Visual Analogue Scale		Through study completion, approximately 1 year
Secondary	Relative frequency, nature, and severity of adverse events (AEs) and serious adverse events (SAEs)		Through study completion, approximately 1 year
Secondary	Serum trough levels of ustekinumab		Through study completion, approximately 1 year
Secondary	Number of patients with antibodies to ustekinumab		Through study completion, approximately 1 year