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.

Tracking Information

• First Submitted Date: August 19, 2022
• First Posted Date: August 22, 2022
• Last Update Posted Date: May 25, 2023
• Actual Study Start Date: August 4, 2022
• Actual Primary Completion Date: April 4, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2022)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis
• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Plaque Psoriasis

Intervention

• Drug: Humira (Adalimumab)
  Subcutaneous (SC) injection
• Drug: SB5 (Adalimumab Biosimilar)
  Subcutaneous (SC) injection

Study Arms

• 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.
  Interventions:

  • Drug: Humira (Adalimumab)
  • Drug: SB5 (Adalimumab Biosimilar)
• 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.
  Intervention: Drug: Humira (Adalimumab)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 23, 2023): 371
• Original Estimated Enrollment (submitted: August 19, 2022): 366
• Actual Study Completion Date: May 4, 2023
• Actual Primary Completion Date: April 4, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Czechia, Lithuania, Poland

Administrative Information

• NCT Number: NCT05510063
• Other Study ID Numbers: SB5-4001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Samsung Bioepis Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Samsung Bioepis Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Organon and Co
• Investigators: Not Provided
• PRS Account: Samsung Bioepis Co., Ltd.
• Verification Date: May 2023