A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967508
• Other study ID #: SB17-3001
• Status: Completed
• Phase: Phase 3
• Start date: July 6, 2021
• Est. completion date: November 25, 2022

Study information

• Verified date: April 2022
• Source: Samsung Bioepis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: November 25, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Stelara® (Ustekinumab)
Subjects randomised into Stelara® group will receive Stelara® (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.
• SB17 (Proposed Ustekinumab Biosimilar)
Subjects randomised into SB17 group will receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40. Starting at Week 28, subjects transited from Stelara® to SB17 will receive SB17 via subcutaneous injection.

Locations

Country	Name	City	State
Czechia	SB Investigative Site	Brno
Czechia	SB Investigative Site	Ostrava
Czechia	SB Investigative Site	Pardubice
Czechia	SB Investigative Site	Praha 10
Czechia	SB investigative site	Praha 3
Estonia	SB investigative site	Tallinn
Estonia	SB Investigative Site	Tartu
Hungary	SB Investigative Site	Zalaegerszeg
Korea, Republic of	SB Investigative Site	Seongnam
Korea, Republic of	SB Investigative Site	Suwon
Latvia	SB Investigative Site	Riga
Latvia	SB Investigative Site	Talsi
Lithuania	SB Investigative Site	Kaunas
Lithuania	SB Investigative Site	Vilnius
Poland	SB Investigative Site	Elblag
Poland	SB Investigative Site	Kielce
Poland	SB Investigative Site	Krakow
Poland	SB Investigative Site	Lodz
Poland	SB Investigative Site	Lublin
Poland	SB Investigative Site	Rzeszow
Poland	SB Investigative Site	Siedlce
Poland	SB Investigative Site	Skierniewice
Poland	SB Investigative Site	Swidnik
Poland	SB Investigative Site	Warszawa
Ukraine	SB Investigative Site	Dnipro
Ukraine	SB Investigative Site	Kharkiv
Ukraine	SB Investigative Site	Kherson
Ukraine	SB Investigative Site	Kyiv
Ukraine	SB Investigative Site	Lviv
Ukraine	SB Investigative Site	Odesa
Ukraine	SB Investigative Site	Uzhgorod
Ukraine	SB Investigative Site	Vinnytsia
Ukraine	SB Investigative Site	Zaporizhzhia

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

Czechia,  Estonia,  Hungary,  Korea, Republic of,  Latvia,  Lithuania,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in PASI at Week 12		Baseline and Week 12