search
Back to results

Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Humira (Adalimumab)
SB5 (Adalimumab Biosimilar)
Sponsored by
Samsung Bioepis Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis focused on measuring Psoriasis, Adalimumab

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have no history of Adalimumab and cell-depleting biologics
  • Have no history of any other biologics use within 6 months prior to Week 0
  • 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
  • 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 5 months 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, phototherapy or systemic therapy
  • Known allergic reactions or hypersensitivity to adalimumab or to any ingredients of SB5 or Humira
  • Have received phototherapy or conventional systemic therapy within 4 weeks prior to Week 0
  • Have received topical therapy for psoriasis within 2 weeks prior to Week 0, however class 6/7 corticosteroids are allowed on face and groin
  • Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 5 months after the last dose of IP
  • Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 8 weeks prior to Week 0. Non-live COVID-19 vaccines are allowed
  • 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 lymphoproliferative disease or leukaemia
  • History of malignancy within the last 5 years

Sites / Locations

  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site
  • SB Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Switched between Humira and SB5

Continued on Humira

Arm Description

All subjects will receive an initial dose of Humira 80 mg at Week 0, followed by Humira 40 mg every other week starting one week after the initial dose up to Week 11. From Week 13, the subjects will switch between Humira and SB5 up to Week 23.

All subjects will receive an initial dose of Humira 80 mg at Week 0, followed by Humira 40 mg every other week starting one week after the initial dose up to Week 23.

Outcomes

Primary Outcome Measures

Area under the concentration-time curve over the dosing interval (AUCtau)
Maximum serum concentration during the dosing interval (Cmax)

Secondary Outcome Measures

Full Information

First Posted
August 19, 2022
Last Updated
May 23, 2023
Sponsor
Samsung Bioepis Co., Ltd.
Collaborators
Organon and Co
search

1. Study Identification

Unique Protocol Identification Number
NCT05510063
Brief Title
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Official Title
A Phase IV, Randomized, Double-blind, Parallel-group, Multiple-dose, Active Comparator, Multicenter Clinical Study to Evaluate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2022 (Actual)
Primary Completion Date
April 4, 2023 (Actual)
Study Completion Date
May 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Bioepis Co., Ltd.
Collaborators
Organon and Co

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety, and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque psoriasis.
Detailed Description
The primary objective of this study is to assess the pharmacokinetic similarity in subjects with moderate to severe plaque psoriasis who switch between Humira and SB5 to those receiving Humira continuously. All entered subjects will be treated with Humira during a lead-in period of 13 weeks. At Week 13, subjects who achieved at least a 50% reduction in Psoriasis Area and Severity Index (PASI50) response will be randomized in a 1:1 ratio to either be switched between Humira and SB5 or continue on Humira.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Psoriasis, Adalimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
371 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Switched between Humira and SB5
Arm Type
Experimental
Arm Description
All subjects will receive an initial dose of Humira 80 mg at Week 0, followed by Humira 40 mg every other week starting one week after the initial dose up to Week 11. From Week 13, the subjects will switch between Humira and SB5 up to Week 23.
Arm Title
Continued on Humira
Arm Type
Active Comparator
Arm Description
All subjects will receive an initial dose of Humira 80 mg at Week 0, followed by Humira 40 mg every other week starting one week after the initial dose up to Week 23.
Intervention Type
Drug
Intervention Name(s)
Humira (Adalimumab)
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
SB5 (Adalimumab Biosimilar)
Intervention Description
Subcutaneous (SC) injection
Primary Outcome Measure Information:
Title
Area under the concentration-time curve over the dosing interval (AUCtau)
Time Frame
Week 23 to Week 25
Title
Maximum serum concentration during the dosing interval (Cmax)
Time Frame
Week 23 to Week 25

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have no history of Adalimumab and cell-depleting biologics Have no history of any other biologics use within 6 months prior to Week 0 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 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 5 months 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, phototherapy or systemic therapy Known allergic reactions or hypersensitivity to adalimumab or to any ingredients of SB5 or Humira Have received phototherapy or conventional systemic therapy within 4 weeks prior to Week 0 Have received topical therapy for psoriasis within 2 weeks prior to Week 0, however class 6/7 corticosteroids are allowed on face and groin Women who are pregnant or nursing at Screening, or men and women planning pregnancy during the study period and until 5 months after the last dose of IP Have received a live or live attenuated viral vaccine or a live bacterial vaccine within 8 weeks prior to Week 0. Non-live COVID-19 vaccines are allowed 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 lymphoproliferative disease or leukaemia History of malignancy within the last 5 years
Facility Information:
Facility Name
SB Investigative Site
City
Dupnitsa
Country
Bulgaria
Facility Name
SB Investigative Site
City
Pleven
Country
Bulgaria
Facility Name
SB Investigative Site
City
Sofia
Country
Bulgaria
Facility Name
SB Investigative Site
City
Ostrava
Country
Czechia
Facility Name
SB Investigative Site
City
Pardubice
Country
Czechia
Facility Name
SB Investigative Site
City
Praha 10
Country
Czechia
Facility Name
SB Investigative Site
City
Praha
Country
Czechia
Facility Name
SB Investigative Site
City
Kaunas
Country
Lithuania
Facility Name
SB Investigative Site
City
Vilnius
Country
Lithuania
Facility Name
SB Investigative Site
City
Białystok
Country
Poland
Facility Name
SB Investigative Site
City
Bydgoszcz
Country
Poland
Facility Name
SB Investigative Site
City
Gdańsk
Country
Poland
Facility Name
SB Investigative Site
City
Gdynia
Country
Poland
Facility Name
SB Investigative Site
City
Kraków
Country
Poland
Facility Name
SB Investigative Site
City
Lublin
Country
Poland
Facility Name
SB Investigative Site
City
Nowa Sól
Country
Poland
Facility Name
SB Investigative Site
City
Olsztyn
Country
Poland
Facility Name
SB Investigative Site
City
Osielsko
Country
Poland
Facility Name
SB Investigative Site
City
Poznań
Country
Poland
Facility Name
SB Investigative Site
City
Siedlce
Country
Poland
Facility Name
SB Investigative Site
City
Szczecin
Country
Poland
Facility Name
SB Investigative Site
City
Warszawa
Country
Poland
Facility Name
SB Investigative Site
City
Łódź
Country
Poland
Facility Name
SB Investigative Site
City
Świdnik
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis

We'll reach out to this number within 24 hrs