Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

  • STATUS
    Recruiting
  • End date
    Sep 14, 2023
  • participants needed
    366
  • sponsor
    Samsung Bioepis Co., Ltd.
Updated on 7 October 2022
Investigator
Samsung Bioepis
Primary Contact
SB Investigative Site (0.0 mi away) Contact
+16 other location

Summary

This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetic, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.

Description

The primary objective of this study is to assess the pharmacokinetic similarity in subjects with moderate to severe plaque psoriasis who switch between Humira and SB5 to those receiving Humira continuously.

All entered subjects will be treated with Humira during a lead-in period of 13 weeks. At Week 13, subjects who achieved at least a 50% reduction in Psoriasis Area and Severity Index (PASI50) response will be randomized in a 1:1 ratio to either be switched between Humira and SB5 or continue on Humira.

Details
Condition Plaque Psoriasis
Treatment Humira (Adalimumab), SB5 (Adalimumab Biosimilar)
Clinical Study IdentifierNCT05510063
SponsorSamsung Bioepis Co., Ltd.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Have no history of Adalimumab and cell-depleting biologics
Have no history of any other biologics use within 6 months prior to Week 0
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
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 5 months 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, phototherapy or systemic therapy
Known allergic reactions or hypersensitivity to adalimumab or to any ingredients of SB5 or Humira
Have received phototherapy or conventional systemic therapy within 4 weeks prior to Week 0
Have received topical therapy for psoriasis within 2 weeks prior to Week 0, however class 6/7 corticosteroids are allowed on face and groin
Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 5 months after the last dose of IP
Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 8 weeks prior to Week 0. Non-live COVID-19 vaccines are allowed
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 lymphoproliferative disease or leukaemia
History of malignancy within the last 5 years
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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