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A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04967508
Recruitment Status : Active, not recruiting
First Posted : July 19, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 8, 2021
First Posted Date  ICMJE July 19, 2021
Last Update Posted Date April 15, 2022
Actual Study Start Date  ICMJE July 6, 2021
Actual Primary Completion Date February 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2021)
Percent change from baseline in PASI at Week 12 [ Time Frame: Baseline and Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis
Official Title  ICMJE A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (Proposed Ustekinumab Biosimilar) Compared to Stelara® in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.
Detailed Description Subjects will be randomised in a 1:1 ratio to receive either SB17 or Stelara® via subcutaneous injection. At Week 28, subjects receiving Stelara® will be randomised again in a 1:1 ratio to either continue on Stelara® or be transitioned to SB17. Investigational products (IPs) (SB17 or Stelara®) will be administered at Week 0, 4, and then every 12 weeks up to Week 40, and the last assessment will be done at Week 52.
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
  • Psoriasis
  • Moderate to Severe Plaque Psoriasis
Intervention  ICMJE
  • Drug: Stelara® (Ustekinumab)
    Subjects randomised into Stelara® group will receive Stelara® (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.
  • Drug: SB17 (Proposed Ustekinumab Biosimilar)

    Subjects randomised into SB17 group will receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.

    Starting at Week 28, subjects transited from Stelara® to SB17 will receive SB17 via subcutaneous injection.

Study Arms  ICMJE
  • Experimental: SB17 (Proposed Ustekinumab Biosimilar)
    Intervention: Drug: SB17 (Proposed Ustekinumab Biosimilar)
  • Active Comparator: Stelara® (Ustekinumab)
    Interventions:
    • Drug: Stelara® (Ustekinumab)
    • Drug: SB17 (Proposed Ustekinumab Biosimilar)
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 6, 2022)
503
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2021)
464
Estimated Study Completion Date  ICMJE December 2022
Actual Primary Completion Date February 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 18 years or older at Screening.
  • Have plaque psoriasis diagnosed at least 6 months, with or without psoriatic arthritis.
  • Have plaque psoriasis with the involvement and severity of total affected BSA ≥ 10%, PASI score of ≥ 12 and PGA score of ≥ 3 (moderate).
  • Considered to be a candidate for phototherapy or systemic therapy for psoriasis
  • Less than 95 kg of body weight.
  • Adequate hematological, renal and hepatic function by central lab.
  • Non-childbearing potential female, or childbearing potential female subjects or male subjects with their partners who agree to use at least two forms of appropriate contraception method from Screening until 15 weeks after the last dose of IP.

Exclusion Criteria:

  • Have nonplaque forms of psoriasis, including erythrodermic, pustular, guttate, or drug-induced psoriasis.
  • Have other skin disease than psoriasis that requires topical or systemic corticosteroids.
  • Prior biologic use as any TNF inhibitors within the previous 6 months; any IL-12 or IL-23 inhibitor biologics, IL-17 inhibitor, rituximab, or integrin inhibitor biologics at any time; or other biologics within the longer of either 5 half-lives or 3 months prior to randomisation.
  • Known allergic reactions or hypersensitivity to ustekinumab or to any ingredients of Stelara® or SB17
  • History of exfoliative dermatitis, reversible posterior leukoencephalopathy syndrome, facial palsy, allergic alveolitis, or non-infectious pneumonia.
  • Have received phototherapy or conventional systemic therapy for psoriasis within 4 weeks prior to Randomisation.
  • Have received topical therapy for psoriasis within 2 weeks prior to Randomisation.
  • Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 15 weeks after the last dose of IP.
  • Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 4 weeks (for BCG, 12 months) prior to Randomisation.
  • Have active or latent tuberculosis.
  • History of ongoing infection or a positive test of HBV, HCV, or HIV infection
  • History of sepsis, chronic or recurrent infection
  • History of malignancy within the last 5 years
  • History of lymphoproliferative disease or leukemia
  • History of myocardial infarction, NYHA III/IV congestive heart failure, or stroke within 12 months
  • Have uncontrolled hypertension or diabetes
  • History of uncontrolled psychiatric disorders or risk of suicide
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Estonia,   Hungary,   Korea, Republic of,   Latvia,   Lithuania,   Poland,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04967508
Other Study ID Numbers  ICMJE SB17-3001
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 Not Provided
Responsible Party Samsung Bioepis Co., Ltd.
Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Samsung Bioepis Co., Ltd.
Verification Date April 2022

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