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

Sponsor
Mabscale, LLC
Study ID
NCT06005532
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab injection 40 mg / 0.8 ml
  • Humira — DRUG
    Adalimumab injection 40 mg / 0.4 ml

Study Details

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.

Key Dates

Start date
Oct 2, 2023
Status verified
Nov 2023
Primary completion
Mar 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
494 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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) ]

Central Contacts

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