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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Samsung Bioepis Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Estonia, Lithuania

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Moderate to Severe Plaque Psoriasis
Additional Details

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.

Arms & Interventions


Experimental: SB17 (Proposed Ustekinumab Biosimilar)

Active Comparator: Stelara® (Ustekinumab)


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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

SB Investigative Site, Tartu, Estonia




SB Investigative Site

Tartu, ,

SB investigative site, Vilnius, Lithuania




SB investigative site

Vilnius, ,

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