PsoriasisPhase 3NCT04967508
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Stelara® (Ustekinumab) and SB17 (Proposed Ustekinumab Biosimilar) in people with Psoriasis and Moderate to Severe Plaque Psoriasis, run by Samsung Bioepis Co., Ltd. at 32 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Moderate to Severe Plaque Psoriasis
- What is being tested?
- Stelara® (Ustekinumab) and SB17 (Proposed Ustekinumab Biosimilar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 32 sitesin 8 countries
- Study dates
- 6 Jul 2021to 25 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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 locations and contacts
32 sites in 8 countries.
32 sites in 8 countries
Poland10 sites
SB Investigative Site
Elblag
SB Investigative Site
Kielce
SB Investigative Site
Krakow
SB Investigative Site
Lodz
SB Investigative Site
Lublin
SB Investigative Site
Rzeszów
SB Investigative Site
Siedlce
SB Investigative Site
Skierniewice
SB Investigative Site
Świdnik
SB Investigative Site
Warsaw
Ukraine9 sites
SB Investigative Site
Dnipro
SB Investigative Site
Kharkiv
SB Investigative Site
Kherson
SB Investigative Site
Kyiv
SB Investigative Site
Lviv
SB Investigative Site
Odesa
SB Investigative Site
Uzhhorod
SB Investigative Site
Vinnytsia
SB Investigative Site
Zaporizhzhya
Czechia4 sites
SB Investigative Site
Brno
SB Investigative Site
Ostrava
SB Investigative Site
Pardubice
SB Investigative Site
Prague
South Korea2 sites
SB Investigative Site
Seongnam
SB Investigative Site
Suwon
About this study
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
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.
Read the 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
- Being tested
- Stelara® (Ustekinumab), SB17 (Proposed Ustekinumab Biosimilar)
- Keywords
- Psoriasis, Plaque Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| SB17 (Proposed Ustekinumab Biosimilar) | Experimental | Not described Receives: Drug: SB17 (Proposed Ustekinumab Biosimilar) |
| Stelara® (Ustekinumab) | Active comparator | Not described Receives: Drug: Stelara® (Ustekinumab); Drug: SB17 (Proposed Ustekinumab Biosimilar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start6 Jul 2021
- Primary completion24 Feb 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967508
- Sponsor's protocol ID
- SB17-3001
- Status last verified
- May 2025
- First submitted
- 8 Jul 2021
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04967508
- Acronym / sponsor ID
- SB17-3001
- Conditions
- Psoriasis, Moderate to Severe Plaque Psoriasis
- Keywords
- Psoriasis, Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SB17 (Proposed Ustekinumab Biosimilar) | Experimental | Drug: SB17 (Proposed Ustekinumab Biosimilar) |
| Stelara® (Ustekinumab) | Active comparator | Drug: Stelara® (Ustekinumab), Drug: SB17 (Proposed Ustekinumab Biosimilar) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Stelara® (Ustekinumab) |
| 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. | Drug | SB17 (Proposed Ustekinumab Biosimilar), Stelara® (Ustekinumab) |
Primary outcome
Percent Change From Baseline in PASI at Week 12
Time frame: Baseline and 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stelara® (Ustekinumab) and SB17 (Proposed Ustekinumab Biosimilar) in people with Psoriasis and Moderate to Severe Plaque Psoriasis, run by Samsung Bioepis Co., Ltd. at 32 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Poland, Ukraine, Czechia, Estonia, Latvia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in PASI at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.