CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 374 enrolled
Drug / intervention
Humira 40 MG in Prefilled Syringe +1 morebiological
Likely dose
Humira 40 MG in Prefilled Syringefrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05637515
NCT05637515Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Blinded, Parallel Group, Interchangeability Study in Moderate to Severe Chronic Plaque Psoriasis Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity Between Subjects Receiving Humira® Pre Filled Syringe (40 mg) Continuously and Subjects Undergoing Repeated Switches Between Humira® Pre Filled Syringe (40 mg) and Hulio Pre-filled Syringe (40 mg)

Biocon Biologics Inc.·interventional·Posted Dec 5, 2022·Updated Oct 22, 2024

In Brief

A Phase 3 clinical trial evaluating Humira 40 MG in Prefilled Syringe and Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe for Moderate Chronic Plaque Psoriasis and Severe Chronic Plaque Psoriasis. Completed, enrolled 374 participants across 36 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis
CountriesBulgaria, Czechia, Estonia, Poland
CollaboratorsMylan Inc., MEDA Pharma GmbH & Co. KG, IQVIA Pvt. Ltd

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedDec 5, 2022
Enrollment StartNov 21, 2022
Primary CompletionSep 19, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.6 years ago

Interventions

Humira 40 MG in Prefilled Syringebiological

Humira (40 mg every other week)

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

• 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.