Moderate to Severe Plaque Psoriasis, Psoriasis
Conditions
Keywords
Psoriasis, Plaque Psoriasis
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.
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.
Interventions
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.
DRUGSB17 (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.
Sponsors
Samsung Bioepis Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in PASI at Week 12 | 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. |
Countries
Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, South Korea, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 249 |
| 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). | 254 |
| Total | 503 |
Baseline characteristics
| Characteristic | SB17 (Proposed Ustekinumab Biosimilar) | Stelara (Ustekinumab) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 15 Participants | 19 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 234 Participants | 234 Participants | 468 Participants |
| Age, Continuous | 44.0 years STANDARD_DEVIATION 13.21 | 44.3 years STANDARD_DEVIATION 12.42 | 44.2 years STANDARD_DEVIATION 12.81 |
| Body Mass Index (BMI) | 27.2 kg/m2 STANDARD_DEVIATION 3.94 | 26.8 kg/m2 STANDARD_DEVIATION 3.66 | 27.0 kg/m2 STANDARD_DEVIATION 3.81 |
| Dermatology Life Quality Index (DLQI) at baseline | 13.4 scores on a scale STANDARD_DEVIATION 7.24 | 13.2 scores on a scale STANDARD_DEVIATION 6.96 | 13.3 scores on a scale STANDARD_DEVIATION 7.09 |
| Duration of psoriasis | 15.0 years STANDARD_DEVIATION 11.38 | 16.1 years STANDARD_DEVIATION 11.88 | 15.6 years STANDARD_DEVIATION 11.64 |
| History of psoriatic arthritis No | 185 Participants | 200 Participants | 385 Participants |
| History of psoriatic arthritis Yes | 64 Participants | 54 Participants | 118 Participants |
| PASI at baseline | 22.5 index STANDARD_DEVIATION 7.82 | 22.1 index STANDARD_DEVIATION 7.69 | 22.3 index STANDARD_DEVIATION 7.75 |
| PGA Score of ≥ 4 (Marked or Severe) at baseline | 92 Participants | 94 Participants | 186 Participants |
| Race/Ethnicity, Customized Ethnicity Korean | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Ethnicity Mixed Ethnicity | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 247 Participants | 249 Participants | 496 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 247 Participants | 250 Participants | 497 Participants |
| Sex: Female, Male Female | 99 Participants | 92 Participants | 191 Participants |
| Sex: Female, Male Male | 150 Participants | 162 Participants | 312 Participants |
| Total psoriasis BSA involvement | 27.3 % STANDARD_DEVIATION 13.49 | 26.7 % STANDARD_DEVIATION 13.77 | 27.0 % STANDARD_DEVIATION 13.62 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 249 | 0 / 254 | 0 / 122 | 0 / 122 |
| other Total, other adverse events | 50 / 249 | 62 / 254 | 28 / 122 | 31 / 122 |
| serious Total, serious adverse events | 7 / 249 | 6 / 254 | 2 / 122 | 3 / 122 |
Outcome results
Primary
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SB17 (Proposed Ustekinumab Biosimilar) | Percent Change From Baseline in PASI at Week 12 | 85.7 Percent change | Standard Error 2.53 |
| Stelara (Ustekinumab) | Percent Change From Baseline in PASI at Week 12 | 86.3 Percent change | Standard Error 2.41 |