Comparing the effectiveness and safety of Adalimumab to Humira for plaque psoriasis

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

This study is testing if a new version of a psoriasis medication called Adalimumab works as well and is as safe as the original medication, Humira, for adults with moderate to severe plaque psoriasis.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Mabscale, LLC (Industry-sponsored)
• Drugs / interventions: Adalimumab
• Locations: 9 sites (Barnaul and 8 other locations)
• Trial ID: NCT06005532 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and immunogenicity of Adalimumab, a proposed biosimilar to Humira®, in adult patients with moderate to severe chronic plaque psoriasis. It is a double-blind, randomized, multicenter study designed to meet regulatory requirements for biosimilar approval. Participants will receive either Adalimumab or Humira® to determine if the new treatment is as effective and safe as the established medication.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with moderate to severe plaque psoriasis who have not responded adequately to previous systemic therapies.

Not a fit: Patients with other forms of psoriasis or those who have had severe hypersensitivity reactions to the treatment components may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment for patients with chronic plaque psoriasis.

How similar studies have performed: Other studies have shown success with biosimilars in similar conditions, indicating a promising approach for this trial.

Eligibility criteria

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.

Where this trial is running

Barnaul and 8 other locations

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

Study contacts

• Study coordinator: Yulia BASKAEVA

Conditions Plaque Psoriasis