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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FYB202 (Proposed ustekinumab biosimilar) | Experimental | Patients will receive subcutaneous injections of FYB202 as detailed in the protocol. |
|
| Stelara® (Ustekinumab) | Active Comparator | Patients will receive subcutaneous injections of Stelara® as detailed in the protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent improvement in Psoriasis Area and Severity Index (PASI) score | Week 12 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
Patients with active infection or history of infections as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Study Official | Bioeq GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tallinn | Estonia | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40048101 | Derived | 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. |
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| 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. |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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