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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06005532
Other study ID # MABPS-3/2020
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 2, 2023
Est. completion date December 2025

Study information

Verified date November 2023
Source Mabscale, LLC
Contact Yulia BASKAEVA
Phone +74997149289
Email baskaeva.y@benerix.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.


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 psoriasis. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.


Recruitment information / eligibility

Status Recruiting
Enrollment 494
Est. completion date December 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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-a 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Adalimumab
Adalimumab injection 40 mg / 0.8 ml
Humira
Adalimumab injection 40 mg / 0.4 ml

Locations

Country Name City State
Russian Federation Regional dermatovenerologic dispensary Barnaul
Russian Federation Chelyabinsk Regional Clinical Dermatovenerologic Dispensary Chelyabinsk
Russian Federation Interregional Clinical Diagnostic Center Kazan'
Russian Federation City clinical hospital n.a.Botkin Moscow
Russian Federation Rheumatology research Instititue n.a.Nasonova Moscow
Russian Federation State Scientific Center of Dermatovenerology and Cosmetology Nizhny Novgorod
Russian Federation Reafan Novosibirsk
Russian Federation New Clinic Pyatigorsk
Russian Federation Dermatovenerologic dispensary N10 Saint Petersburg

Sponsors (1)

Lead Sponsor Collaborator
Mabscale, LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients who achieved a response according to the PASI criterion of 75 (a decrease in the severity and prevalence of psoriasis by =75% from the baseline level assessed by the PASI index) after 16 weeks of therapy (assessment at Visit 10)
Primary Proportion of patients with positive antibody titer to Adalimumab 51 weeks of therapy
Primary Percentage of patients who have neutralizing antibodies to Adalimumab 51 weeks of therapy
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