Trial Outcomes & Findings for A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis (NCT NCT04967508)
NCT ID: NCT04967508
Last Updated: 2025-05-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
503 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2025-05-25
Participant Flow
Participant milestones
| Measure |
SB17 (Proposed Ustekinumab Biosimilar)
Subjects were randomised into SB17 (Proposed Ustekinumab Biosimilar) group to receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the SB17 group were re-randomised (to maintain blindness) but continued to receive SB17 during the transition period (i.e., Week 28 and Week 40).
|
Stelara (Ustekinumab)
Subjects were randomised into Stelara (Ustekinumab) group to receive Stelara (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the Stelara (Ustekinumab) group were re-randomised and either transitioned to SB17 or continued to receive Stelara during the transition period (i.e., Week 28 and Week 40).
|
Stelara to SB17
Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive SB17 once every 12 weeks during the transition period (i.e., Week 28 and Week 40).
|
Stelara to Stelara
Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive Stelara (Ustekinumab) once every 12 weeks during the transition period (i.e., Week 28 and Week 40).
|
|---|---|---|---|---|
|
Main Period
STARTED
|
249
|
254
|
0
|
0
|
|
Main Period
COMPLETED
|
237
|
244
|
0
|
0
|
|
Main Period
NOT COMPLETED
|
12
|
10
|
0
|
0
|
|
Transition Period
STARTED
|
237
|
0
|
122
|
122
|
|
Transition Period
COMPLETED
|
233
|
0
|
117
|
116
|
|
Transition Period
NOT COMPLETED
|
4
|
0
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to Stelara® in Subject With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
SB17 (Proposed Ustekinumab Biosimilar)
n=249 Participants
Subjects were randomised into SB17 (Proposed Ustekinumab Biosimilar) group to receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the SB17 group were re-randomised (to maintain blindness) but continued to receive SB17 during the transition period (i.e., Week 28 and Week 40).
|
Stelara (Ustekinumab)
n=254 Participants
Subjects were randomised into Stelara (Ustekinumab) group to receive Stelara (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the Stelara (Ustekinumab) group were re-randomised and either transitioned to SB17 or continued to receive Stelara during the transition period (i.e., Week 28 and Week 40).
|
Total
n=503 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
234 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
468 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 12.42 • n=7 Participants
|
44.2 years
STANDARD_DEVIATION 12.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
150 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
312 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Korean
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Mixed Ethnicity
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
247 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
247 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
27.2 kg/m2
STANDARD_DEVIATION 3.94 • n=5 Participants
|
26.8 kg/m2
STANDARD_DEVIATION 3.66 • n=7 Participants
|
27.0 kg/m2
STANDARD_DEVIATION 3.81 • n=5 Participants
|
|
Total psoriasis BSA involvement
|
27.3 %
STANDARD_DEVIATION 13.49 • n=5 Participants
|
26.7 %
STANDARD_DEVIATION 13.77 • n=7 Participants
|
27.0 %
STANDARD_DEVIATION 13.62 • n=5 Participants
|
|
Duration of psoriasis
|
15.0 years
STANDARD_DEVIATION 11.38 • n=5 Participants
|
16.1 years
STANDARD_DEVIATION 11.88 • n=7 Participants
|
15.6 years
STANDARD_DEVIATION 11.64 • n=5 Participants
|
|
PASI at baseline
|
22.5 index
STANDARD_DEVIATION 7.82 • n=5 Participants
|
22.1 index
STANDARD_DEVIATION 7.69 • n=7 Participants
|
22.3 index
STANDARD_DEVIATION 7.75 • n=5 Participants
|
|
PGA Score of ≥ 4 (Marked or Severe) at baseline
|
92 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Dermatology Life Quality Index (DLQI) at baseline
|
13.4 scores on a scale
STANDARD_DEVIATION 7.24 • n=5 Participants
|
13.2 scores on a scale
STANDARD_DEVIATION 6.96 • n=7 Participants
|
13.3 scores on a scale
STANDARD_DEVIATION 7.09 • n=5 Participants
|
|
History of psoriatic arthritis
Yes
|
64 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
History of psoriatic arthritis
No
|
185 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
385 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Psoriasis 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.
Outcome measures
| Measure |
Stelara (Ustekinumab)
n=249 Participants
Subjects were randomised into Stelara (Ustekinumab) group to receive Stelara (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the Stelara (Ustekinumab) group were re-randomised and either transitioned to SB17 or continued to receive Stelara during the transition period (i.e., Week 28 and Week 40).
|
SB17 (Proposed Ustekinumab Biosimilar)
n=243 Participants
Subjects were randomised into SB17 (Proposed Ustekinumab Biosimilar) group to receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the SB17 group were re-randomised (to maintain blindness) but continued to receive SB17 during the transition period (i.e., Week 28 and Week 40).
|
|---|---|---|
|
Percent Change From Baseline in PASI at Week 12
|
86.3 Percent change
Standard Error 2.41
|
85.7 Percent change
Standard Error 2.53
|
Adverse Events
SB17 (Proposed Ustekinumab Biosimilar)
Serious events: 7 serious events
Other events: 50 other events
Deaths: 0 deaths
Stelara (Ustekinumab)
Serious events: 6 serious events
Other events: 62 other events
Deaths: 0 deaths
Stelara to SB17
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Stelara to Stelara
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB17 (Proposed Ustekinumab Biosimilar)
n=249 participants at risk
Subjects were randomised into SB17 (Proposed Ustekinumab Biosimilar) group to receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the SB17 group were re-randomised (to maintain blindness) but continued to receive SB17 during the transition period (i.e., Week 28 and Week 40).
|
Stelara (Ustekinumab)
n=254 participants at risk
Subjects were randomised into Stelara (Ustekinumab) group to receive Stelara (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the Stelara (Ustekinumab) group were re-randomised and either transitioned to SB17 or continued to receive Stelara during the transition period (i.e., Week 28 and Week 40).
|
Stelara to SB17
n=122 participants at risk
Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive SB17 once every 12 weeks during the transition period (i.e., Week 28 and Week 40).
|
Stelara to Stelara
n=122 participants at risk
Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive Stelara (Ustekinumab) once every 12 weeks during the transition period (i.e., Week 28 and Week 40).
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
1/249 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/254 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/249 • Overall Period (up to 52 weeks)
|
0.39%
1/254 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.82%
1/122 • Number of events 1 • Overall Period (up to 52 weeks)
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/249 • Overall Period (up to 52 weeks)
|
0.39%
1/254 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.82%
1/122 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/249 • Overall Period (up to 52 weeks)
|
0.39%
1/254 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.40%
1/249 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/254 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.40%
1/249 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/254 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.40%
1/249 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/254 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/249 • Overall Period (up to 52 weeks)
|
0.39%
1/254 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.82%
1/122 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.40%
1/249 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/254 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/249 • Overall Period (up to 52 weeks)
|
0.39%
1/254 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.82%
1/122 • Number of events 1 • Overall Period (up to 52 weeks)
|
|
Nervous system disorders
Ischaemic stroke
|
0.40%
1/249 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/254 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Renal and urinary disorders
Prerenal failure
|
0.40%
1/249 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/254 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/249 • Overall Period (up to 52 weeks)
|
0.39%
1/254 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.82%
1/122 • Number of events 1 • Overall Period (up to 52 weeks)
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.00%
0/249 • Overall Period (up to 52 weeks)
|
0.39%
1/254 • Number of events 1 • Overall Period (up to 52 weeks)
|
0.00%
0/122 • Overall Period (up to 52 weeks)
|
0.82%
1/122 • Number of events 1 • Overall Period (up to 52 weeks)
|
Other adverse events
| Measure |
SB17 (Proposed Ustekinumab Biosimilar)
n=249 participants at risk
Subjects were randomised into SB17 (Proposed Ustekinumab Biosimilar) group to receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the SB17 group were re-randomised (to maintain blindness) but continued to receive SB17 during the transition period (i.e., Week 28 and Week 40).
|
Stelara (Ustekinumab)
n=254 participants at risk
Subjects were randomised into Stelara (Ustekinumab) group to receive Stelara (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16).
At Week 28, subjects in the Stelara (Ustekinumab) group were re-randomised and either transitioned to SB17 or continued to receive Stelara during the transition period (i.e., Week 28 and Week 40).
|
Stelara to SB17
n=122 participants at risk
Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive SB17 once every 12 weeks during the transition period (i.e., Week 28 and Week 40).
|
Stelara to Stelara
n=122 participants at risk
Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive Stelara (Ustekinumab) once every 12 weeks during the transition period (i.e., Week 28 and Week 40).
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
9.2%
23/249 • Number of events 26 • Overall Period (up to 52 weeks)
|
9.1%
23/254 • Number of events 30 • Overall Period (up to 52 weeks)
|
9.8%
12/122 • Number of events 16 • Overall Period (up to 52 weeks)
|
8.2%
10/122 • Number of events 12 • Overall Period (up to 52 weeks)
|
|
Infections and infestations
COVID-19
|
7.2%
18/249 • Number of events 19 • Overall Period (up to 52 weeks)
|
11.4%
29/254 • Number of events 29 • Overall Period (up to 52 weeks)
|
9.8%
12/122 • Number of events 12 • Overall Period (up to 52 weeks)
|
12.3%
15/122 • Number of events 15 • Overall Period (up to 52 weeks)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
12/249 • Number of events 15 • Overall Period (up to 52 weeks)
|
6.3%
16/254 • Number of events 19 • Overall Period (up to 52 weeks)
|
6.6%
8/122 • Number of events 10 • Overall Period (up to 52 weeks)
|
6.6%
8/122 • Number of events 9 • Overall Period (up to 52 weeks)
|
Additional Information
Director of Clinical Trials
Samsung Bioepis Co., Ltd
Phone: +82-32-728-0371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place