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

Phase 3

Recruiting

• Conditions: Plaque Psoriasis
• Interventions: Drug: Humira; Drug: Adalimumab

• Registration Number: NCT06005532
• Lead Sponsor: Mabscale, LLC

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.

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 Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-22
• Study Start: 2023-10-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 494

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Humira®	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.
Adalimumab (manufactured by Mabscale, LLC)	Adalimumab	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with positive antibody titer to Adalimumab	51 weeks of therapy
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)
Percentage of patients who have neutralizing antibodies to Adalimumab	51 weeks of therapy

Trial Locations

Locations (9)

Regional dermatovenerologic dispensary; 🇷🇺 Barnaul, Russian Federation

City clinical hospital n.a.Botkin; 🇷🇺 Moscow, Russian Federation

Reafan; 🇷🇺 Novosibirsk, Russian Federation

New Clinic; 🇷🇺 Pyatigorsk, Russian Federation

Chelyabinsk Regional Clinical Dermatovenerologic Dispensary; 🇷🇺 Chelyabinsk, Russian Federation

Interregional Clinical Diagnostic Center; 🇷🇺 Kazan', Russian Federation

State Scientific Center of Dermatovenerology and Cosmetology; 🇷🇺 Nizhny Novgorod, Russian Federation

Dermatovenerologic dispensary N10; 🇷🇺 Saint Petersburg, Russian Federation

Rheumatology research Instititue n.a.Nasonova; 🇷🇺 Moscow, Russian Federation