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

NCT06005532 | Unknown Phase 3

• 1 other identifier: MABPS-3/2020
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 9

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Adalimumab (manufactured by Mabscale, LLC)

EXPERIMENTAL

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

Humira®

ACTIVE COMPARATOR

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

Interventions

Adalimumab DRUG

Adalimumab injection 40 mg / 0.8 ml

Adalimumab (manufactured by Mabscale, LLC)

Humira DRUG

Adalimumab injection 40 mg / 0.4 ml

Humira®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mabscale, LLC: lead

Study Sites (9)

Regional dermatovenerologic dispensary

Barnaul, Russia

RECRUITING

Chelyabinsk Regional Clinical Dermatovenerologic Dispensary

Chelyabinsk, Russia

RECRUITING

Interregional Clinical Diagnostic Center

Kazan', Russia

NOT YET RECRUITING

City clinical hospital n.a.Botkin

Moscow, Russia

NOT YET RECRUITING

Rheumatology research Instititue n.a.Nasonova

Moscow, Russia

NOT YET RECRUITING

State Scientific Center of Dermatovenerology and Cosmetology

Nizhny Novgorod, Russia

NOT YET RECRUITING

Reafan

Novosibirsk, Russia

NOT YET RECRUITING

New Clinic

Pyatigorsk, Russia

NOT YET RECRUITING

Dermatovenerologic dispensary N10

Saint Petersburg, Russia

NOT YET RECRUITING

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yulia BASKAEVA

CONTACT

+74997149289; baskaeva.y@benerix.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 22, 2023
• Study Start: October 2, 2023
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

RU (9)