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Clinical Trial Summary

Hulio is a monoclonal antibody currently approved as a biosimilar to European Union approved and United States (US)-Licensed Humira. This is a multicenter, randomized blinded, parallel group, interchangeability study in subjects with moderate to severe chronic plaque psoriasis, undergoing repeated switches between Humira and Hulio. The study is designed to confirm the pharmacokinetic equivalence of alternating between the use of Humira and Hulio and, Humira without such alternation or switch, in accordance with the US Food and Drug Administration Guidance for Industry, Considerations in Demonstrating Interchangeability with a Reference Product. The study will also assess safety, efficacy and immunogenicity between these two groups.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05637515
Study type Interventional
Source Biocon Limited
Contact
Status Completed
Phase Phase 3
Start date November 21, 2022
Completion date September 19, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04123795 - A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO) Phase 3