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

NCT ID: NCT05510063

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 371 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-04
• Study Completion Date: 2023-05-04

Brief Summary

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

Detailed 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.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Switched between Humira and SB5

All subjects will receive an initial dose of Humira 80 mg at Week 0, followed by Humira 40 mg every other week starting one week after the initial dose up to Week 11. From Week 13, the subjects will switch between Humira and SB5 up to Week 23.

Group Type: EXPERIMENTAL

Humira (Adalimumab)

Intervention Type: DRUG

Subcutaneous (SC) injection

SB5 (Adalimumab Biosimilar)

Intervention Type: DRUG

Subcutaneous (SC) injection

Continued on Humira

All subjects will receive an initial dose of Humira 80 mg at Week 0, followed by Humira 40 mg every other week starting one week after the initial dose up to Week 23.

Group Type: ACTIVE_COMPARATOR

Humira (Adalimumab)

Intervention Type: DRUG

Subcutaneous (SC) injection

Interventions

Humira (Adalimumab)

Subcutaneous (SC) injection

Intervention Type: DRUG

SB5 (Adalimumab Biosimilar)

Subcutaneous (SC) injection

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: collaborator

Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SB Investigative Site

Dupnitsa, , Bulgaria

SB Investigative Site

Pleven, , Bulgaria

SB Investigative Site

Sofia, , Bulgaria

SB Investigative Site

Ostrava, , Czechia

SB Investigative Site

Pardubice, , Czechia

SB Investigative Site

Prague, , Czechia

SB Investigative Site

Kaunas, , Lithuania

SB Investigative Site

Vilnius, , Lithuania

SB Investigative Site

Bialystok, , Poland

SB Investigative Site

Bydgoszcz, , Poland

SB Investigative Site

Gdansk, , Poland

SB Investigative Site

Gdynia, , Poland

SB Investigative Site

Krakow, , Poland

SB Investigative Site

Lodz, , Poland

SB Investigative Site

Lublin, , Poland

SB Investigative Site

Nowa Sól, , Poland

SB Investigative Site

Olsztyn, , Poland

SB Investigative Site

Osielsko, , Poland

SB Investigative Site

Poznan, , Poland

SB Investigative Site

Siedlce, , Poland

SB Investigative Site

Szczecin, , Poland

SB Investigative Site

Świdnik, , Poland

SB Investigative Site

Warsaw, , Poland

Countries

Bulgaria; Czechia; Lithuania; Poland

Other Identifiers

SB5-4001

Identifier Type: -

Identifier Source: org_study_id