Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®

Launched by MABSCALE, LLC · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial, called MABPS-3/2020, is looking at how well a new drug called Adalimumab, made by Mabscale, LLC, works compared to the well-known medication Humira® for treating adults with moderate to severe plaque psoriasis. The study aims to understand not only how effective these treatments are but also how safe they are and how the body responds to them. Plaque psoriasis is a skin condition that causes red, flaky patches, and this trial is specifically for adults aged 18 to 65 who have had this condition for at least six months and haven’t had success with other treatments.

To participate in the study, individuals must weigh between 110 and 265 pounds and have a diagnosis of plaque psoriasis that is moderate to severe. However, those with certain health issues, like severe allergies, active infections, or a history of specific cancers, may not be eligible. Participants can expect regular check-ups and monitoring throughout the trial to ensure their safety and gather information about how well the treatments are working. Overall, this study is important for finding new options for people struggling with plaque psoriasis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent.
• • 2. Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
• • 3. Established clinical diagnosis plaque psoriasis, lasting at least 6 months before the screening.
• 4. Plaque psoriasis of moderate or severe severity of stable course with:
• • PASI ≥ 12 points;
• • BSA ≥ 10 %;
• • sPGA ≥ 3 points.
• • 5. Patients who have been shown to undergo systemic therapy and/or patients who have had insufficient therapeutic efficacy of at least 1 previous standard systemic therapy for psoriasis, including phototherapy, therapy with cytostatic and immunosuppressive drugs, or who have had intolerance to standard systemic therapy.
• Exclusion Criteria:
• • 1. Data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations.
• • 2. A history of severe hypersensitivity reactions of any etiology.
• • 3. Other (other than plaque) forms of psoriasis.
• • 4. Drug-induced psoriasis.
• • 5. Data on the use of the Adalimumab or any preparations of monoclonal antibodies inhibiting TNF-α at any time during life.
• • 6. The presence of Adalimumab antibodies.
• • 7. Extensive surgical intervention performed less than 30 days before the screening period, or planned extensive surgical intervention during the study period.
• • 8. Active or latent tuberculosis
• • 9. Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a history of multiple myeloma.
• • 10. Any other malignant neoplasms currently or in anamnesis within the last 5 years, with the exception of completely removed and/or cured.
• • 11. Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to the screening period.
• • 12. Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C, HIV.
• • 13. Vaccination with live or attenuated vaccines within 8 weeks before the screening period.
• • 14. Hepatic and/or renal insufficiency.
• • 15. Pregnancy or lactation.