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

NCT ID: NCT04967508

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2022-11-25

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.

Conditions

Psoriasis; Moderate to Severe Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SB17 (Proposed Ustekinumab Biosimilar)

Group Type: EXPERIMENTAL

SB17 (Proposed Ustekinumab Biosimilar)

Intervention Type: DRUG

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.

Stelara® (Ustekinumab)

Group Type: ACTIVE_COMPARATOR

Stelara® (Ustekinumab)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Bioepis Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SB Investigative Site

Brno, , Czechia

SB Investigative Site

Ostrava, , Czechia

SB Investigative Site

Pardubice, , Czechia

SB Investigative Site

Prague, , Czechia

SB investigative site

Tallinn, , Estonia

SB Investigative Site

Tartu, , Estonia

SB Investigative Site

Zalaegerszeg, , Hungary

SB Investigative Site

Riga, , Latvia

SB Investigative Site

Talsi, , Latvia

SB Investigative Site

Kaunas, , Lithuania

SB Investigative Site

Vilnius, , Lithuania

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

Rzeszów, , Poland

SB Investigative Site

Siedlce, , Poland

SB Investigative Site

Skierniewice, , Poland

SB Investigative Site

Świdnik, , Poland

SB Investigative Site

Warsaw, , Poland

SB Investigative Site

Seongnam, , South Korea

SB Investigative Site

Suwon, , South Korea

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

Uzhhorod, , Ukraine

SB Investigative Site

Vinnytsia, , Ukraine

SB Investigative Site

Zaporizhzhia, , Ukraine

Countries

Czechia; Estonia; Hungary; Latvia; Lithuania; Poland; South Korea; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SB17-3001

Identifier Type: -

Identifier Source: org_study_id