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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

Tracking Information
First Submitted Date  ICMJE October 14, 2020
First Posted Date  ICMJE October 20, 2020
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE September 23, 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
Percent improvement in Psoriasis Area and Severity Index (PASI) score [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: FYB202 (Proposed ustekinumab biosimilar)
    Patients will receive subcutaneous injections of FYB202 as detailed in the protocol.
    Intervention: Drug: FYB202 (Proposed ustekinumab biosimilar)
  • Active Comparator: Stelara® (Ustekinumab)
    Patients will receive subcutaneous injections of Stelara® as detailed in the protocol.
    Intervention: Drug: Stelara® (Ustekinumab)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 14, 2020)
392
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: bioeq GmbH +49802446333299 vespucci@bioeq.com
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04595409
Other Study ID Numbers  ICMJE FYB202-03-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bioeq GmbH
Study Sponsor  ICMJE Bioeq GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Official Bioeq GmbH
PRS Account Bioeq GmbH
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP