A Phase 3 interventional study of Stelara® (Ustekinumab) and SB17 (Proposed Ustekinumab Biosimilar) in Psoriasis and Moderate to Severe Plaque Psoriasis, sponsored by Samsung Bioepis Co., Ltd.. Completed at 33 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Samsung Bioepis Co., Ltd. · Phase 3, Interventional, and Treatment
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Among 166 studies in Psoriasis with a site in Poland — 7 open to participants now, 20 under way, 18 of them phase 3. Psoriasis · Poland.
Among the 166 studies in Psoriasis with a site in Poland, this one is the 69th largest by enrollment of the 162 interventional ones that give a count, is one of 11 that started in 2021, is one of 106 in phase 3, and was the 124th registered.
2,030 studies on the registry are indexed under Psoriasis; 277 are open to participants now.
Browse Psoriasis studies →7 of the 166 studies in Psoriasis with a site in Poland are open now. Recruiting first, the newest first:
Takeda · Sites in Poland, United States, China and 4 more countries
Ages 4–17
Bristol-Myers Squibb · Sites in Poland, United States, Argentina and 13 more countries
Ages 12–17
Chong Kun Dang Pharmaceutical · Sites in Poland
Ages 18–55 · Healthy volunteers
UCB Biopharma SRL · Sites in Poland, United States, Canada and 10 more countries
Ages 18+
Bristol-Myers Squibb · Sites in Poland, United States, Argentina and 22 more countries
Ages 40+
A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →
Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
166 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 40 · Phase 3 108 · Phase 4 9
First in 2002; this study’s year is marked. 11 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 503 is above the median of 75 across 1,567 interventional studies indexed under Psoriasis.
Median enrollment 376 across the 162 interventional studies, 2,032 across the 4 observational. Of the 145 that completed or were terminated, 111 (77%) have results posted.
This tab as a report to print or save as PDF → With an account.
162 of 166 have an industry lead sponsor. The 10 most frequent:
Samsung Bioepis Co., Ltd. is the lead sponsor of 33 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Samsung Bioepis Co., Ltd. has 2 studies filed under Psoriasis — fewer than ten, so there is no comparison to draw.
1 of the studies in Psoriasis with a site in Poland that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07013201LEO PharmaA 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis | 2027-06-04 |
Add it to your calendar (.ics) → With an account.
Among the 166 studies in Psoriasis with a site in Poland, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: SB17 (Proposed Ustekinumab Biosimilar)
Drug: Stelara® (Ustekinumab) · Drug: SB17 (Proposed Ustekinumab Biosimilar)
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.
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.
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.
Time frame: Baseline and Week 12
| Milestone | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Stelara to SB17 | Stelara to Stelara |
|---|---|---|---|---|
| Started | 249 | 254 | 0 | 0 |
| Completed | 237 | 244 | 0 | 0 |
| Not completed | 12 | 10 | 0 | 0 |
| Milestone | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Stelara to SB17 | Stelara to Stelara |
|---|---|---|---|---|
| Started | 237 | 0 | 122 | 122 |
| Completed | 233 | 0 | 117 | 116 |
| Not completed | 4 | 0 | 5 | 6 |
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.
| Percent change | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) |
|---|---|---|
| Percent Change From Baseline in PASI at Week 12 | 85.7 ± 2.53 | 86.3 ± 2.41 |
Collected over Overall Period (up to 52 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SB17 (Proposed Ustekinumab Biosimilar) | 0/249 (0%) | 7/249 (2.8%) | 50/249 (20.1%) |
| Stelara (Ustekinumab) | 0/254 (0%) | 6/254 (2.4%) | 62/254 (24.4%) |
| Stelara to SB17 | 0/122 (0%) | 2/122 (1.6%) | 28/122 (23%) |
| Stelara to Stelara | 0/122 (0%) | 3/122 (2.5%) | 31/122 (25.4%) |
| Event | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Stelara to SB17 | Stelara to Stelara |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/249 | 1/254 | 0/122 | 1/122 |
| Salivary gland calculusGastrointestinal disorders | 0/249 | 1/254 | 1/122 | 0/122 |
| Tibia fractureInjury, poisoning and procedural complications | 0/249 | 1/254 | 1/122 | 0/122 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/249 | 1/254 | 0/122 | 1/122 |
| Ovarian cyst torsionReproductive system and breast disorders | 0/249 | 1/254 | 0/122 | 1/122 |
| Pelvic adhesionsReproductive system and breast disorders | 0/249 | 1/254 | 0/122 | 1/122 |
| Acute myocardial infarctionCardiac disorders | 1/249 | 0/254 | 0/122 | 0/122 |
| Fibula fractureInjury, poisoning and procedural complications | 1/249 | 0/254 | 0/122 | 0/122 |
| Joint dislocationInjury, poisoning and procedural complications | 1/249 | 0/254 | 0/122 | 0/122 |
| Meniscus injuryInjury, poisoning and procedural complications | 1/249 | 0/254 | 0/122 | 0/122 |
| Event | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Stelara to SB17 | Stelara to Stelara |
|---|---|---|---|---|
| COVID-19Infections and infestations | 18/249 | 29/254 | 12/122 | 15/122 |
| NasopharyngitisInfections and infestations | 23/249 | 23/254 | 12/122 | 10/122 |
| Upper respiratory tract infectionInfections and infestations | 12/249 | 16/254 | 8/122 | 8/122 |
| Age, Categorical(Participants) | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| <=18 years | 0 | 1 | 1 |
| Between 18 and 65 years | 234 | 234 | 468 |
| >=65 years | 15 | 19 | 34 |
| Age, Continuous(years) | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| Mean | 44.0 ± 13.21 | 44.3 ± 12.42 | 44.2 ± 12.81 |
| Sex: Female, Male(Participants) | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| Female | 99 | 92 | 191 |
| Male | 150 | 162 | 312 |
| Race/Ethnicity, Customized(Participants) | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| Ethnicity — Korean | 2 | 4 | 6 |
| Ethnicity — Mixed Ethnicity | 0 | 1 | 1 |
| Ethnicity — Other | 247 | 249 | 496 |
| Race/Ethnicity, Customized(Participants) | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| Race — Asian | 2 | 4 | 6 |
| Race — White | 247 | 250 | 497 |
| Body Mass Index (BMI)(kg/m2) | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| Mean | 27.2 ± 3.94 | 26.8 ± 3.66 | 27.0 ± 3.81 |
| Total psoriasis BSA involvement(%) | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| Mean | 27.3 ± 13.49 | 26.7 ± 13.77 | 27.0 ± 13.62 |
| Duration of psoriasis(years) | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| Mean | 15.0 ± 11.38 | 16.1 ± 11.88 | 15.6 ± 11.64 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2021 to primary completion in Feb 2022, 7 months.
Results were first posted in May 2025, 3 years 3 months after primary completion.
Of 217 industry-sponsored phase 3 interventional studies under Psoriasis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's 7 months is below that.
Counting every sponsor, half of 227 studies reached it within 15 months; a quarter within 10 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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