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

  • STATUS
    Recruiting
  • End date
    Mar 27, 2023
  • participants needed
    464
  • sponsor
    Samsung Bioepis Co., Ltd.
Updated on 27 July 2021
systemic therapy
ustekinumab
phototherapy
arthritis
plaque psoriasis

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.

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.

Details
Condition Psoriasis, Moderate to Severe Plaque Psoriasis
Treatment Stelara® (Ustekinumab), SB17 (Proposed Ustekinumab Biosimilar)
Clinical Study IdentifierNCT04967508
SponsorSamsung Bioepis Co., Ltd.
Last Modified on27 July 2021

Eligibility

Yes No Not Sure

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
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