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Trial record 1 of 1 for:    FYB202
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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)

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ClinicalTrials.gov Identifier: NCT04595409
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bioeq GmbH

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: FYB202 (Proposed ustekinumab biosimilar) Drug: Stelara® (Ustekinumab) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

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.




Primary Outcome Measures :
  1. Percent improvement in Psoriasis Area and Severity Index (PASI) score [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Percent improvement in PASI score [ Time Frame: Through study completion, approximately 1 year ]
  2. Raw PASI score [ Time Frame: Through study completion, approximately 1 year ]
  3. Proportion of patients with PASI 75 and PASI 90 [ Time Frame: Through study completion, approximately 1 year ]
  4. Change per Physician's Global Assessment (PGA) [ Time Frame: Through study completion, approximately 1 year ]
  5. Improvement of Dermatology Life Quality Index (DLQI) total score [ Time Frame: Through study completion, approximately 1 year ]
  6. Itching Visual Analogue Scale [ Time Frame: Through study completion, approximately 1 year ]
  7. Relative frequency, nature, and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Through study completion, approximately 1 year ]
  8. Serum trough levels of ustekinumab [ Time Frame: Through study completion, approximately 1 year ]
  9. Number of patients with antibodies to ustekinumab [ Time Frame: Through study completion, approximately 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595409


Contacts
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Contact: bioeq GmbH +49802446333299 vespucci@bioeq.com

Locations
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Poland
Research Site Recruiting
Białystok, Poland
Research Site Recruiting
Toruń, Poland
Sponsors and Collaborators
Bioeq GmbH
Investigators
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Study Director: Study Official Bioeq GmbH
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Responsible Party: Bioeq GmbH
ClinicalTrials.gov Identifier: NCT04595409    
Other Study ID Numbers: FYB202-03-01
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents