Clinical trial NCT04967508: A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis
Official title: A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SB17 (Proposed Ustekinumab Biosimilar) Compared to Stelara® in Subjects With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Moderate to Severe Plaque Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Lead sponsor: Samsung Bioepis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-19
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.

Detailed description: Subjects will be randomised in a 1:1 ratio to receive either SB17 or Stelara® via subcutaneous injection. At Week 28, subjects receiving Stelara® will be randomised again in a 1:1 ratio to either continue on Stelara® or be transitioned to SB17. Investigational products (IPs) (SB17 or Stelara®) will be administered at Week 0, 4, and then every 12 weeks up to Week 40, and the last assessment will be done at Week 52.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older at Screening.
* 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
* Less than 95 kg of body weight.
* 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 15 weeks 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 or systemic corticosteroids.
* Prior biologic use as any TNF inhibitors within the previous 6 months; any IL-12 or IL-23 inhibitor biologics, IL-17 inhibitor, rituximab, or integrin inhibitor biologics at any time; or other biologics within the longer of either 5 half-lives or 3 months prior to randomisation.
* Known allergic reactions or hypersensitivity to ustekinumab or to any ingredients of Stelara® or SB17
* History of exfoliative dermatitis, reversible posterior leukoencephalopathy syndrome, facial palsy, allergic alveolitis, or non-infectious pneumonia.
* Have received phototherapy or conventional systemic therapy for psoriasis within 4 weeks prior to Randomisation.
* Have received topical therapy for psoriasis within 2 weeks prior to Randomisation.
* Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 15 weeks after the last dose of IP.
* Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 4 weeks (for BCG, 12 months) prior to Randomisation.
* 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 malignancy within the last 5 years
* History of lymphoproliferative disease or leukemia
* History of myocardial infarction, NYHA III/IV congestive heart failure, or stroke within 12 months
* Have uncontrolled hypertension or diabetes
* History of uncontrolled psychiatric disorders or risk of suicide

Primary outcomes:
measure: Percent Change From Baseline in PASI at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
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 3
country: Czechia
facility: SB investigative site
city: Tallinn
country: Estonia
facility: SB investigative site
city: Tartu
country: Estonia
facility: SB Investigative Site
city: Zalaegerszeg
country: Hungary
facility: SB Investigative Site
city: Seongnam
country: Korea, Republic of
facility: SB Investigative Site
city: Suwon
country: Korea, Republic of
facility: SB Investigative Site
city: Riga
country: Latvia
facility: SB Investigative Site
city: Talsi
country: Latvia
facility: SB Investigative Site
city: Kaunas
country: Lithuania
facility: SB Investigative Site
city: Vilnius
country: Lithuania
facility: SB Investigative Site
city: Elbląg
country: Poland
facility: SB Investigative Site
city: Kielce
country: Poland
facility: SB Investigative Site
city: Krakow
country: Poland
facility: SB Investigative Site
city: Lodz
country: Poland
facility: SB Investigative Site
city: Lublin
country: Poland
facility: SB Investigative Site
city: Rzeszow
country: Poland
facility: SB Investigative Site
city: Siedlce
country: Poland
facility: SB Investigative Site
city: Skierniewice
country: Poland
facility: SB Investigative Site
city: Swidnik
country: Poland
facility: SB Investigative Site
city: Warszawa
country: Poland
facility: SB Investigative Site
city: Dnipro
country: Ukraine
facility: SB Investigative Site
city: Kharkiv
country: Ukraine
facility: SB Investigative Site
city: Kherson
country: Ukraine
facility: SB Investigative Site
city: Kyiv
country: Ukraine
facility: SB Investigative Site
city: Lviv
country: Ukraine
facility: SB Investigative Site
city: Odesa
country: Ukraine
facility: SB Investigative Site
city: Uzhgorod
country: Ukraine
facility: SB Investigative Site
city: Vinnytsia
country: Ukraine
facility: SB Investigative Site
city: Zaporizhzhia
country: Ukraine
facility: SB Investigative Site
Study officials:
References: