Clinical trial NCT05510063: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Adalimumab
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Organon and Co
First posted: 2022-08-22
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Area under the concentration-time curve over the dosing interval (AUCtau)
timeFrame: Week 23 to Week 25
measure: Maximum serum concentration during the dosing interval (Cmax)
timeFrame: Week 23 to Week 25
Secondary outcomes:
Other outcomes:
Locations:
city: Dupnitsa
country: Bulgaria
facility: SB Investigative Site
city: Pleven
country: Bulgaria
facility: SB Investigative Site
city: Sofia
country: Bulgaria
facility: SB Investigative Site
city: Ostrava
country: Czechia
facility: SB Investigative Site
city: Pardubice
country: Czechia
facility: SB Investigative Site
city: Praha 10
country: Czechia
facility: SB Investigative Site
city: Praha
country: Czechia
facility: SB Investigative Site
city: Kaunas
country: Lithuania
facility: SB Investigative Site
city: Vilnius
country: Lithuania
facility: SB Investigative Site
city: Białystok
country: Poland
facility: SB Investigative Site
city: Bydgoszcz
country: Poland
facility: SB Investigative Site
city: Gdańsk
country: Poland
facility: SB Investigative Site
city: Gdynia
country: Poland
facility: SB Investigative Site
city: Kraków
country: Poland
facility: SB Investigative Site
city: Lublin
country: Poland
facility: SB Investigative Site
city: Nowa Sól
country: Poland
facility: SB Investigative Site
city: Olsztyn
country: Poland
facility: SB Investigative Site
city: Osielsko
country: Poland
facility: SB Investigative Site
city: Poznań
country: Poland
facility: SB Investigative Site
city: Siedlce
country: Poland
facility: SB Investigative Site
city: Szczecin
country: Poland
facility: SB Investigative Site
city: Warszawa
country: Poland
facility: SB Investigative Site
city: Łódź
country: Poland
facility: SB Investigative Site
city: Świdnik
country: Poland
facility: SB Investigative Site
Study officials:
References: