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

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ClinicalTrials.gov Identifier: NCT04967508
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Psoriasis Moderate to Severe Plaque Psoriasis Drug: Stelara® (Ustekinumab) Drug: SB17 (Proposed Ustekinumab Biosimilar) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 6, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Experimental: SB17 (Proposed Ustekinumab Biosimilar) 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.


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.





Primary Outcome Measures :
  1. Percent change from baseline in PASI at Week 12 [ Time Frame: Baseline and Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04967508


Contacts
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Contact: Samsung Bioepis +82 32 728 0371 sbregistry@samsung.com

Locations
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Estonia
SB Investigative Site Recruiting
Tartu, Estonia
Lithuania
SB investigative site Recruiting
Vilnius, Lithuania
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT04967508    
Other Study ID Numbers: SB17-3001
First Posted: July 19, 2021    Key Record Dates
Last Update Posted: July 19, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Samsung Bioepis Co., Ltd.:
Psoriasis
Plaque Psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents