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| Name | Class |
|---|---|
| Organon and Co | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Humira (Adalimumab) | Drug | Subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve over the dosing interval (AUCtau) | Week 23 to Week 25 | |
| Maximum serum concentration during the dosing interval (Cmax) | Week 23 to Week 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SB Investigative Site | Dupnitsa | Bulgaria | ||||
| SB Investigative Site |
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| SB5 (Adalimumab Biosimilar) | Drug | Subcutaneous (SC) injection |
|
| Pleven |
| Bulgaria |
| SB Investigative Site | Sofia | Bulgaria |
| SB Investigative Site | Ostrava | Czechia |
| SB Investigative Site | Pardubice | Czechia |
| SB Investigative Site | Prague | Czechia |
| SB Investigative Site | Kaunas | Lithuania |
| SB Investigative Site | Vilnius | Lithuania |
| SB Investigative Site | Bialystok | Poland |
| SB Investigative Site | Bydgoszcz | Poland |
| SB Investigative Site | Gdansk | Poland |
| SB Investigative Site | Gdynia | Poland |
| SB Investigative Site | Krakow | Poland |
| SB Investigative Site | Lodz | 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 | Szczecin | Poland |
| SB Investigative Site | Świdnik | Poland |
| SB Investigative Site | Warsaw | Poland |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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