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

Conditions

• Moderate Chronic Plaque Psoriasis
• Severe Chronic Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Humira 40 MG in Prefilled Syringe — BIOLOGICAL
  Humira (40 mg every other week)
• Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe — BIOLOGICAL
  • 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.

Study Details

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.

Key Dates

Start date

Nov 21, 2022

Status verified

Oct 2024

Primary completion

Sep 19, 2023

Completion

Sep 19, 2023

Study Design

Enrollment

374 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Humira continuously
  Subjects receive Humira continuously both during Run-in period and Randomized interchangeable treatment period. Run-in Period: 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). Randomized interchangeable treatment period: Subjects continue to receive Humira (40 mg every other week) until Week 26
• Experimental: Repeated switches Humira - Hulio
  Subjects will receive Humira in Run-in period \& undergo repeated switches between Humira Hulio during randomized interchangeable treatment period Randomized interchangeable treatment period: * Subjects undergo repeated switches between Humira and Hulio between week 12 to week 26. * 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.

Primary Outcome Measure

Primary Endpoints: Pharmacokinetics (PK) - AUC [ Time Frame: Week 26 - 28 ]