Plaque Psoriasis Clinical Trial
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
NCT number | NCT05510063 |
Other study ID # | SB5-4001 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | August 4, 2022 |
Est. completion date | May 4, 2023 |
Verified date | May 2023 |
Source | Samsung Bioepis Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 371 |
Est. completion date | May 4, 2023 |
Est. primary completion date | April 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | SB Investigative Site | Dupnitsa | |
Bulgaria | SB Investigative Site | Pleven | |
Bulgaria | SB Investigative Site | Sofia | |
Czechia | SB Investigative Site | Ostrava | |
Czechia | SB Investigative Site | Pardubice | |
Czechia | SB Investigative Site | Praha | |
Czechia | SB Investigative Site | Praha 10 | |
Lithuania | SB Investigative Site | Kaunas | |
Lithuania | SB Investigative Site | Vilnius | |
Poland | SB Investigative Site | Bialystok | |
Poland | SB Investigative Site | Bydgoszcz | |
Poland | SB Investigative Site | Gdansk | |
Poland | SB Investigative Site | Gdynia | |
Poland | SB Investigative Site | Kraków | |
Poland | SB Investigative Site | Lódz | |
Poland | SB Investigative Site | Lublin | |
Poland | SB Investigative Site | Nowa Sól | |
Poland | SB Investigative Site | Olsztyn | |
Poland | SB Investigative Site | Osielsko | |
Poland | SB Investigative Site | Poznan | |
Poland | SB Investigative Site | Siedlce | |
Poland | SB Investigative Site | Swidnik | |
Poland | SB Investigative Site | Szczecin | |
Poland | SB Investigative Site | Warszawa |
Lead Sponsor | Collaborator |
---|---|
Samsung Bioepis Co., Ltd. | Organon and Co |
Bulgaria, Czechia, Lithuania, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the concentration-time curve over the dosing interval (AUCtau) | Week 23 to Week 25 | ||
Primary | Maximum serum concentration during the dosing interval (Cmax) | Week 23 to Week 25 |
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