Plaque PsoriasisPhase 3VESPUCCINCT04595409
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
A Phase 3 study testing FYB202 (Proposed ustekinumab biosimilar) and Stelara® (Ustekinumab) in people with Plaque Psoriasis, run by Bioeq GmbH at 16 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- FYB202 (Proposed ustekinumab biosimilar) and Stelara® (Ustekinumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 9 Nov 2020to 21 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Poland8 sites
Research Site
Bialystok
Research Site
Gdansk
Research Site
Krakow
Research Site
Lodz
Research Site
Olsztyn
Research Site
Torun
Research Site
Warsaw
Research Site
Wroclaw
Ukraine5 sites
Research Site
Dnipro
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Rivne
Research Site
Zaporizhzhya
About this study
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
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
- Being tested
- FYB202 (Proposed ustekinumab biosimilar), Stelara® (Ustekinumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| FYB202 (Proposed ustekinumab biosimilar) | Experimental | Patients will receive subcutaneous injections of FYB202 as detailed in the protocol. Receives: Drug: FYB202 (Proposed ustekinumab biosimilar) |
| Stelara® (Ustekinumab) | Active comparator | Patients will receive subcutaneous injections of Stelara® as detailed in the protocol. Receives: Drug: Stelara® (Ustekinumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent improvement in Psoriasis Area and Severity Index (PASI) score
Measured: Week 12
Secondary outcomes (9)
Percent improvement in PASI score
Measured: Through study completion, approximately 1 year
Raw PASI score
Measured: Through study completion, approximately 1 year
Proportion of patients with PASI 75 and PASI 90
Measured: Through study completion, approximately 1 year
Change per Physician's Global Assessment (PGA)
Measured: Through study completion, approximately 1 year
Improvement of Dermatology Life Quality Index (DLQI) total score
Measured: Through study completion, approximately 1 year
Itching Visual Analogue Scale
Measured: Through study completion, approximately 1 year
Relative frequency, nature, and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: Through study completion, approximately 1 year
Serum trough levels of ustekinumab
Measured: Through study completion, approximately 1 year
Number of patients with antibodies to ustekinumab
Measured: Through study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start9 Nov 2020
- Primary completion7 Jun 2021
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioeq GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Bioeq GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595409
- Sponsor's protocol ID
- FYB202-03-01
- Acronym
- VESPUCCI
- Status last verified
- Feb 2023
- First submitted
- 14 Oct 2020
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40048101
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04595409
- Acronym / sponsor ID
- VESPUCCI / FYB202-03-01
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Bioeq GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FYB202 (Proposed ustekinumab biosimilar) | Experimental | Drug: FYB202 (Proposed ustekinumab biosimilar)Patients will receive subcutaneous injections of FYB202 as detailed in the protocol. |
| Stelara® (Ustekinumab) | Active comparator | Drug: Stelara® (Ustekinumab)Patients will receive subcutaneous injections of Stelara® as detailed in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | FYB202 (Proposed ustekinumab biosimilar) |
| 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. | Drug | Stelara® (Ustekinumab) |
Primary outcome
Percent improvement in Psoriasis Area and Severity Index (PASI) score
Time frame: Week 12
9 secondary outcomes
Percent improvement in PASI score
Time frame: Through study completion, approximately 1 year
Raw PASI score
Time frame: Through study completion, approximately 1 year
Proportion of patients with PASI 75 and PASI 90
Time frame: Through study completion, approximately 1 year
Change per Physician's Global Assessment (PGA)
Time frame: Through study completion, approximately 1 year
Improvement of Dermatology Life Quality Index (DLQI) total score
Time frame: Through study completion, approximately 1 year
Itching Visual Analogue Scale
Time frame: Through study completion, approximately 1 year
Relative frequency, nature, and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Through study completion, approximately 1 year
Serum trough levels of ustekinumab
Time frame: Through study completion, approximately 1 year
Number of patients with antibodies to ustekinumab
Time frame: Through study completion, approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Derived from this study: PubMed 40048101Papp 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Official study director
Bioeq GmbH
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FYB202 (Proposed ustekinumab biosimilar) and Stelara® (Ustekinumab) in people with Plaque Psoriasis, run by Bioeq GmbH at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Poland, Ukraine, Estonia, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent improvement in Psoriasis Area and Severity Index (PASI) score (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.