Status:
UNKNOWN
Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®
Lead Sponsor:
Mabscale, LLC
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®. The purp...
Detailed Description
Adalimumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients with chronic plaque...
Eligibility Criteria
Inclusion
- Written informed consent.
- Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
- Established clinical diagnosis plaque psoriasis, lasting at least 6 months before the screening.
- Plaque psoriasis of moderate or severe severity of stable course with:
- PASI ≥ 12 points;
- BSA ≥ 10 %;
- sPGA ≥ 3 points.
- 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
- Data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations.
- A history of severe hypersensitivity reactions of any etiology.
- Other (other than plaque) forms of psoriasis.
- Drug-induced psoriasis.
- Data on the use of the Adalimumab or any preparations of monoclonal antibodies inhibiting TNF-α at any time during life.
- The presence of Adalimumab antibodies.
- Extensive surgical intervention performed less than 30 days before the screening period, or planned extensive surgical intervention during the study period.
- Active or latent tuberculosis
- Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a history of multiple myeloma.
- Any other malignant neoplasms currently or in anamnesis within the last 5 years, with the exception of completely removed and/or cured.
- Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to the screening period.
- Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C, HIV.
- Vaccination with live or attenuated vaccines within 8 weeks before the screening period.
- Hepatic and/or renal insufficiency.
- Pregnancy or lactation.
Key Trial Info
Start Date :
October 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT06005532
Start Date
October 2 2023
End Date
December 1 2025
Last Update
November 29 2023
Active Locations (9)
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1
Regional dermatovenerologic dispensary
Barnaul, Russia
2
Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
Chelyabinsk, Russia
3
Interregional Clinical Diagnostic Center
Kazan', Russia
4
City clinical hospital n.a.Botkin
Moscow, Russia