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Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity

NCT05637515 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2024-10-22

Study results available
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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.

Conditions

  • Moderate Chronic Plaque Psoriasis
  • Severe Chronic Plaque Psoriasis

Interventions

BIOLOGICAL

Humira 40 MG in Prefilled Syringe

Humira (40 mg every other week)

BIOLOGICAL

Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe

• Subjects will receive Humira (initial dose of 80 mg \[2 × 40 mg\]; Day 1 administered subcutaneously (SC), followed by 40 mg SC given every other week starting 1 week after the initial dose (last dose at Week 10). Hulio (40 mg every other week) at Week 12 and Week 14 * Humira (40 mg every other week) at Week 16 and Week 18, and * Hulio (40 mg every other week) at Week 20, Week 22, Week 24 and Week 26.

Sponsors & Collaborators

  • Mylan Inc.

    collaborator INDUSTRY

  • MEDA Pharma GmbH & Co. KG

    collaborator INDUSTRY

  • IQVIA Pvt. Ltd

    collaborator INDUSTRY

  • Biocon Biologics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-21
Primary Completion
2023-09-19
Completion
2023-09-19
FDA Drug
Yes

Countries

  • Bulgaria
  • Czechia
  • Estonia
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05637515 on ClinicalTrials.gov