Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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 psoriasis.
This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adalimumab (manufactured by Mabscale, LLC) In the main period, patients will begin Visit 1 receiving Adalimumab therapy at an initial dose (80 /0, 16 ml) on Visit 1, from Visit 2 Adalimumab therapy at a maintenance dose (40 /0, 8 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days. In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 8 ml)) every 2 weeks until the end of a trial. |
Drug: Adalimumab
Adalimumab injection 40 mg / 0.8 ml
|
| Active Comparator: Humira® In the main period, patients will begin Visit 1 receiving Humira® therapy at an initial dose (80 /0, 8 ml) on Visit 1, from Visit 2 Humira® therapy at a maintenance dose (40 /0, 4 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days. In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 4 ml)) every 2 weeks until the end of a trial. |
Drug: Humira
Adalimumab injection 40 mg / 0.4 ml
|
Outcome Measures
Primary Outcome Measures
- 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)]
- Proportion of patients with positive antibody titer to Adalimumab [51 weeks of therapy]
- Percentage of patients who have neutralizing antibodies to Adalimumab [51 weeks of therapy]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent.
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Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
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Established clinical diagnosis plaque psoriasis, lasting at least 6 months before the screening.
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Plaque psoriasis of moderate or severe severity of stable course with:
-
PASI ≥ 12 points;
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BSA ≥ 10 %;
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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 Criteria:
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Data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations.
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A history of severe hypersensitivity reactions of any etiology.
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Other (other than plaque) forms of psoriasis.
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Drug-induced psoriasis.
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Data on the use of the Adalimumab or any preparations of monoclonal antibodies inhibiting TNF-α at any time during life.
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The presence of Adalimumab antibodies.
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Extensive surgical intervention performed less than 30 days before the screening period, or planned extensive surgical intervention during the study period.
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Active or latent tuberculosis
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Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a history of multiple myeloma.
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Any other malignant neoplasms currently or in anamnesis within the last 5 years, with the exception of completely removed and/or cured.
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Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to the screening period.
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Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C, HIV.
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Vaccination with live or attenuated vaccines within 8 weeks before the screening period.
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Hepatic and/or renal insufficiency.
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Pregnancy or lactation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Regional dermatovenerologic dispensary | Barnaul | Russian Federation | ||
| 2 | Chelyabinsk Regional Clinical Dermatovenerologic Dispensary | Chelyabinsk | Russian Federation | ||
| 3 | Interregional Clinical Diagnostic Center | Kazan' | Russian Federation | ||
| 4 | City clinical hospital n.a.Botkin | Moscow | Russian Federation | ||
| 5 | Rheumatology research Instititue n.a.Nasonova | Moscow | Russian Federation | ||
| 6 | State Scientific Center of Dermatovenerology and Cosmetology | Nizhny Novgorod | Russian Federation | ||
| 7 | Reafan | Novosibirsk | Russian Federation | ||
| 8 | New Clinic | Pyatigorsk | Russian Federation | ||
| 9 | Dermatovenerologic dispensary N10 | Saint Petersburg | Russian Federation |
Sponsors and Collaborators
- Mabscale, LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MABPS-3/2020