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

November 28, 2023 updated by: Mabscale, LLC

Randomized Double Blind Phase III Trial Comparative Clinical Safety, Efficacy and Immunogenicity of Adalimumab (Manufactured by Mabscale, LLC) to Humira®.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

494

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Barnaul, Russian Federation
        • Recruiting
        • Regional dermatovenerologic dispensary
        • Contact:
          • Kovaleva
      • Chelyabinsk, Russian Federation
        • Recruiting
        • Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
        • Contact:
          • Ziganshin
      • Kazan', Russian Federation
        • Not yet recruiting
        • Interregional Clinical Diagnostic Center
        • Contact:
          • Isaeva
      • Moscow, Russian Federation
        • Not yet recruiting
        • City clinical hospital n.a.Botkin
        • Contact:
          • Sotnikova
      • Moscow, Russian Federation
        • Not yet recruiting
        • Rheumatology research Instititue n.a.Nasonova
        • Contact:
          • Korsakova
      • Nizhny Novgorod, Russian Federation
        • Not yet recruiting
        • State Scientific Center of Dermatovenerology and Cosmetology
        • Contact:
          • Gorodnichev
      • Novosibirsk, Russian Federation
        • Not yet recruiting
        • Reafan
        • Contact:
          • Filippova
      • Pyatigorsk, Russian Federation
        • Not yet recruiting
        • New Clinic
        • Contact:
          • Chistyakova
      • Saint Petersburg, Russian Federation
        • Not yet recruiting
        • Dermatovenerologic dispensary N10
        • Contact:
          • Sukharev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: after 16 weeks of therapy (assessment at Visit 10)
after 16 weeks of therapy (assessment at Visit 10)
Proportion of patients with positive antibody titer to Adalimumab
Time Frame: 51 weeks of therapy
51 weeks of therapy
Percentage of patients who have neutralizing antibodies to Adalimumab
Time Frame: 51 weeks of therapy
51 weeks of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mabscale, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

August 21, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MABPS-3/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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