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

• ClinicalTrials.gov Identifier: NCT05510063
• Recruitment Status: Completed
• First Posted: August 22, 2022
• Last Update Posted: May 25, 2023
• Sponsor: Samsung Bioepis Co., Ltd.
• Collaborator: Organon and Co
• Information provided by (Responsible Party): Samsung Bioepis Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Drug: Humira (Adalimumab); Drug: SB5 (Adalimumab Biosimilar)	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 371 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 4, 2022
• Actual Primary Completion Date: April 4, 2023
• Actual Study Completion Date: May 4, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Humira (Adalimumab); Subcutaneous (SC) injection; Drug: SB5 (Adalimumab Biosimilar); Subcutaneous (SC) injection
Active Comparator: 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.	Drug: Humira (Adalimumab); Subcutaneous (SC) injection

Outcome Measures

Primary Outcome Measures :

1. Area under the concentration-time curve over the dosing interval (AUCtau) [ Time Frame: Week 23 to Week 25 ]
2. Maximum serum concentration during the dosing interval (Cmax) [ Time Frame: Week 23 to Week 25 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Bulgaria

SB Investigative Site

Dupnitsa, Bulgaria

SB Investigative Site

Pleven, Bulgaria

SB Investigative Site

Sofia, Bulgaria

Czechia

SB Investigative Site

Ostrava, Czechia

SB Investigative Site

Pardubice, Czechia

SB Investigative Site

Praha 10, Czechia

SB Investigative Site

Praha, Czechia

Lithuania

SB Investigative Site

Kaunas, Lithuania

SB Investigative Site

Vilnius, Lithuania

Poland

SB Investigative Site

Białystok, Poland

SB Investigative Site

Bydgoszcz, Poland

SB Investigative Site

Gdańsk, Poland

SB Investigative Site

Gdynia, Poland

SB Investigative Site

Kraków, 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

Poznań, Poland

SB Investigative Site

Siedlce, Poland

SB Investigative Site

Szczecin, Poland

SB Investigative Site

Warszawa, Poland

SB Investigative Site

Łódź, Poland

SB Investigative Site

Świdnik, Poland

Sponsors and Collaborators

Samsung Bioepis Co., Ltd.

Organon and Co

More Information

• Responsible Party: Samsung Bioepis Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05510063
• Other Study ID Numbers: SB5-4001
• First Posted: August 22, 2022
• Last Update Posted: May 25, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samsung Bioepis Co., Ltd.:

Psoriasis; Adalimumab

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Adalimumab; Tumor Necrosis Factor Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents