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

NCT04967508 | Completed Phase 3 Results

• 1 other identifier: SB17-3001
• Study Type: interventional
• Target: 503
• Locations: 8 countries
• Sites: 32

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.

Conditions

Psoriasis; Moderate to Severe Plaque Psoriasis

Keywords

Psoriasis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in PASI at Week 12

  Psoriasis area severity index (PASI) measures the activity of psoriasis through erythema, induration and scaling and can range from 0 to 72. The degree of PASI improvement in terms of percent change from baseline at Week 12 is measured.

  Baseline and Week 12

Study Arms (2)

SB17 (Proposed Ustekinumab Biosimilar)

EXPERIMENTAL

Drug: SB17 (Proposed Ustekinumab Biosimilar)

Stelara® (Ustekinumab)

ACTIVE COMPARATOR

Drug: Stelara® (Ustekinumab); Drug: SB17 (Proposed Ustekinumab Biosimilar)

Interventions

Stelara® (Ustekinumab) 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.

Stelara® (Ustekinumab)

SB17 (Proposed Ustekinumab Biosimilar) 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.

SB17 (Proposed Ustekinumab Biosimilar); Stelara® (Ustekinumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (32)

SB Investigative Site

Brno, Czechia

Location

SB Investigative Site

Ostrava, Czechia

Location

SB Investigative Site

Pardubice, Czechia

Location

SB Investigative Site

Prague, Czechia

Location

SB investigative site

Tallinn, Estonia

Location

SB Investigative Site

Tartu, Estonia

Location

SB Investigative Site

Zalaegerszeg, Hungary

Location

SB Investigative Site

Riga, Latvia

Location

SB Investigative Site

Talsi, Latvia

Location

SB Investigative Site

Kaunas, Lithuania

Location

SB Investigative Site

Vilnius, Lithuania

Location

SB Investigative Site

Elblag, Poland

Location

SB Investigative Site

Kielce, Poland

Location

SB Investigative Site

Krakow, Poland

Location

SB Investigative Site

Lodz, Poland

Location

SB Investigative Site

Lublin, Poland

Location

SB Investigative Site

Rzeszów, Poland

Location

SB Investigative Site

Siedlce, Poland

Location

SB Investigative Site

Skierniewice, Poland

Location

SB Investigative Site

Świdnik, Poland

Location

SB Investigative Site

Warsaw, Poland

Location

SB Investigative Site

Seongnam, South Korea

Location

SB Investigative Site

Suwon, South Korea

Location

SB Investigative Site

Dnipro, Ukraine

Location

SB Investigative Site

Kharkiv, Ukraine

Location

SB Investigative Site

Kherson, Ukraine

Location

SB Investigative Site

Kyiv, Ukraine

Location

SB Investigative Site

Lviv, Ukraine

Location

SB Investigative Site

Odesa, Ukraine

Location

SB Investigative Site

Uzhhorod, Ukraine

Location

SB Investigative Site

Vinnytsia, Ukraine

Location

SB Investigative Site

Zaporizhzhia, Ukraine

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Samsung Bioepis Co., Ltd

sbregistry@samsung.com

+82-32-728-0371

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: July 6, 2021
• Primary Completion: February 24, 2022
• Study Completion: November 25, 2022
• Last Updated: May 25, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-05

Locations

HU (1); CZ (4); PL (10); LA (2); LI (2); ES (2); UA (9); KR (2)