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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Bioepis Co., Ltd.
• Treatments: Adalimumab

Criteria

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