Plaque PsoriasisPhase 4NCT05510063
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis
A Phase 4 study testing Humira (Adalimumab) and SB5 (Adalimumab Biosimilar) in people with Plaque Psoriasis, run by Samsung Bioepis Co., Ltd. at 23 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Humira (Adalimumab) and SB5 (Adalimumab Biosimilar)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 4 Aug 2022to 4 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
Poland15 sites
SB Investigative Site
Bialystok
SB Investigative Site
Bydgoszcz
SB Investigative Site
Gdansk
SB Investigative Site
Gdynia
SB Investigative Site
Krakow
SB Investigative Site
Lodz
SB Investigative Site
Lublin
SB Investigative Site
Nowa Sól
SB Investigative Site
Olsztyn
SB Investigative Site
Osielsko
SB Investigative Site
Poznan
SB Investigative Site
Siedlce
SB Investigative Site
Świdnik
SB Investigative Site
Szczecin
SB Investigative Site
Warsaw
Bulgaria3 sites
SB Investigative Site
Dupnitsa
SB Investigative Site
Pleven
SB Investigative Site
Sofia
Czechia3 sites
SB Investigative Site
Ostrava
SB Investigative Site
Pardubice
SB Investigative Site
Prague
About this study
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
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.
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- Humira (Adalimumab), SB5 (Adalimumab Biosimilar)
- Keywords
- Psoriasis, Adalimumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humira (Adalimumab)Drug
Subcutaneous (SC) injection
SB5 (Adalimumab Biosimilar)Drug
Subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Switched between Humira and SB5 | Experimental | 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. Receives: Drug: Humira (Adalimumab); Drug: SB5 (Adalimumab Biosimilar) |
| Continued on Humira | Active comparator | 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. Receives: Drug: Humira (Adalimumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve over the dosing interval (AUCtau)
Measured: Week 23 to Week 25
Maximum serum concentration during the dosing interval (Cmax)
Measured: Week 23 to Week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start4 Aug 2022
- Primary completion4 Apr 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Bioepis Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Organon and Co
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510063
- Sponsor's protocol ID
- SB5-4001
- Status last verified
- May 2023
- First submitted
- 19 Aug 2022
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05510063
- Acronym / sponsor ID
- SB5-4001
- Conditions
- Plaque Psoriasis
- Keywords
- Psoriasis, Adalimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Samsung Bioepis Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Organon and Co
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switched between Humira and SB5 | Experimental | Drug: Humira (Adalimumab), Drug: SB5 (Adalimumab Biosimilar)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. |
| Continued on Humira | Active comparator | Drug: Humira (Adalimumab)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humira (Adalimumab)Subcutaneous (SC) injection | Drug | Continued on Humira, Switched between Humira and SB5 |
| SB5 (Adalimumab Biosimilar)Subcutaneous (SC) injection | Drug | Switched between Humira and SB5 |
Primary outcome
Area under the concentration-time curve over the dosing interval (AUCtau)
Time frame: Week 23 to Week 25
Maximum serum concentration during the dosing interval (Cmax)
Time frame: Week 23 to Week 25
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Humira (Adalimumab) and SB5 (Adalimumab Biosimilar) in people with Plaque Psoriasis, run by Samsung Bioepis Co., Ltd. at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Poland, Bulgaria, Czechia, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve over the dosing interval (AUCtau) (time frame: Week 23 to Week 25). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.