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

NCT05637515 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: ADA-IJZ-30012021-006015-29
• Study Type: interventional
• Target: 374
• Locations: 4 countries
• Sites: 36

Brief 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

Keywords

adalimumab; pharmacokinetics; plaque psoriasis

Outcome Measures

Primary Outcomes (2)

• Primary Endpoints: Pharmacokinetics (PK) - AUC

  AUCτ, 26-28 (Area under the adalimumab concentration-time curve \[AUC\] over the dosing interval of Week 26-28)

  Week 26 - 28

• Primary Endpoints: Pharmacokinetics (PK) - Cmax

  Cmax, 26-28 (Maximum observed adalimumab concentration during the dosing interval Week 26-28).

  Week 26 - 28

Study Arms (2)

Humira continuously

ACTIVE COMPARATOR

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

Biological: Humira 40 MG in Prefilled Syringe

Repeated switches Humira - Hulio

EXPERIMENTAL

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.

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

Interventions

Humira 40 MG in Prefilled Syringe BIOLOGICAL

Humira (40 mg every other week)

Humira continuously

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.

Repeated switches Humira - Hulio

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily provide written informed consent to participate in the study
• Aged 18 to 75 years, inclusive, at the time of Screening
• Has moderate to severe chronic plaque psoriasis for at least 6 months prior to screening and that has involved body surface area ≥10%, PASI ≥12, and static Physicians Global Assessment (sPGA) ≥3 (moderate) at Screening and at Baseline
• Has stable disease for at least 2 months (i.e., without significant changes as defined by the principal investigator \[PI\] or designee)
• Is a candidate for systemic therapy or phototherapy
• Has a previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional antipsoriatic systemic therapy, including methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB)
• Willing to follow the contraception requirement, based on the childbearing potential.

You may not qualify if:

• Subjects must not be enrolled in the study if they meet any of the following criteria:
• Has been diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (e.g., eczema), or other systemic autoimmune disorder/ inflammatory disease at the time of the Screening visit that would interfere with evaluations of the effect of the study treatment of psoriasis
• Prior and concomitant medications: Has prior use of any of the medications specified in the CTP within specified time periods or will require use during the study:
• Has received live or attenuated vaccines during the 4 weeks prior to Screening or has the intention of receiving a live or attenuated vaccine at any time during the study
• Other medical conditions: Known chronic or relevant acute TB
• Has an underlying condition (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal) which, in the opinion of the PI or designee, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy
• Has a planned surgical intervention during the duration of the study and which, in the opinion of the PI or designee, will put the subject at further risk or hinder the subject's ability to maintain compliance with study treatment and the visit schedule
• Has any active and serious infection or history of infections
• Is positive for human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B surface antigen (HbsAg) or is positive for hepatitis B core antibody (HbcAb) at Screening
• Has laboratory abnormalities, including but not limited to clinically significant hematological abnormalities, that, in the opinion of the PI or designee, could cause this study to be detrimental to the subject. The subjects should be excluded if they have the following laboratory abnormalities
• Hemoglobin \<9 g/dL
• Platelet count \<100 000/mm3
• White blood cell count \<3000 cells/mm3
• Aspartate aminotransferase and/or alanine aminotransferase that is persistently ≥2.5 × the upper limit of normal. (Persistently indicates elevated transaminases, at least on two separate occasions)
• Creatinine clearance \<50 mL/min (Cockcroft Gault formula)

Sponsors & Collaborators

• Biocon Biologics Inc.: lead
• Mylan Inc.: collaborator
• MEDA Pharma GmbH & Co. KG: collaborator
• IQVIA Pvt. Ltd: collaborator

Study Sites (36)

Site 407 - Medical Centre "Asklepii", OOD

Dupnitsa, Bulgaria

Location

Site 409 - Medical center Medconsult Pleven OOD

Pleven, Bulgaria

Location

Site 403 - MC Rusemed ltd.

Rousse, Bulgaria

Location

Site 406 - Medical Center Unimed Eood

Sevlievo, Bulgaria

Location

Site 401 - Ambulatory for Specialized Medical Help - skin and venereal diseases

Sofia, Bulgaria

Location

Site 402 - DCC "Alexandrovska", EOOD

Sofia, Bulgaria

Location

Site 404 - DCC Focus 5 - MEOH OOD

Sofia, Bulgaria

Location

Site 405 - Medical Center Hera EOOD

Sofia, Bulgaria

Location

Site 408 - DCC "Alexandrovska", EOOD

Sofia, Bulgaria

Location

Site 410 - DCC XXVIII

Sofia, Bulgaria

Location

Site 304 - CCR Ostrava s.r.o.

Ostrava, Czechia

Location

Site 303 - CCR Czech, a.s.

Pardubice, Czechia

Location

Site 301 - Kozni Ambulance Fialova s.r.o.

Prague, Czechia

Location

Site 302 - CLINTRIAL s.r.o.

Prague, Czechia

Location

Site 203 - North Estonia Medical Centre Foundation

Talinn, Estonia

Location

Site 201 - Tartu University Hospital

Tartu, Estonia

Location

Site 204 - Clinical Research Centre

Tartu, Estonia

Location

Site 205 - OÜ Innomedica

Tartu, Estonia

Location

Site 104 - Clinic Med Daniluk, Nowak Spółka Jawna

Bialystok, Poland

Location

Site 111 - SPECDERM POZNANSKA

Bialystok, Poland

Location

Site 103 - Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Poland

Location

Site 101 - Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska

Elblag, Poland

Location

Site 109 - Centrum Badan Klinicznych P.I. House Sp. z o.o.

Gdansk, Poland

Location

Site 112 - CENTRUM MEDYCZNE ALL-MED

Krakow, Poland

Location

Site 116 - FutureMeds Krakow

Krakow, Poland

Location

Site 106 - ETG Lodz

Lodz, Poland

Location

Site 108 - Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

Lodz, Poland

Location

Site 115 - ETG Lublin

Lublin, Poland

Location

Site 113 - ai centrum medyczne sp. z o.o. sp.k.

Poznan, Poland

Location

Site 120 - Twoja Przychodnia PCM

Poznan, Poland

Location

Site 118 - ETG Siedlce

Siedlce, Poland

Location

Site 114 - ETG Skierniewice

Skierniewice, Poland

Location

Site 105 - Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, Poland

Location

Site 107 - MICS Centrum Medyczne Warszawa

Warsaw, Poland

Location

Site 110 - Clinical Research Group Sp. z o.o.

Warsaw, Poland

Location

Site 117 - MCM POLIMEDICA

Warsaw, Poland

Location

Related Publications (1)

• Deodhar S, Loganathan S, Kadadanamari Subbarama Reddy R, Ranganna GM, Liu S, Hummel MA, Daniluk S, Hanczewska A, Vekovska K, Zegadlo-Mylik M, Pulka G, -Holz EW. Multiple Switches Between Adalimumab-fkjp and Reference Adalimumab in Moderate-to-Severe Chronic Plaque Psoriasis: A Multicenter, Double-Blind, Parallel Group, Randomized Clinical Trial for Interchangeability. Adv Ther. 2025 Aug;42(8):3795-3809. doi: 10.1007/s12325-025-03240-5. Epub 2025 Jun 10.

  PMID: 40493334 DERIVED

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Sarika S Deodhar
• Organization: Biocon Biologics Limited

Sarika.Deodhar@biocon.com

0802808

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: November 21, 2022
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: October 22, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Locations

BU (10); CZ (4); PL (18); ES (4)