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

Moderate Chronic Plaque Psoriasis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05637515
• Other study ID #: ADA-IJZ-3001
• Secondary ID: 2021-006015-29
• Status: Completed
• Phase: Phase 3
• Start date: November 21, 2022
• Est. completion date: September 19, 2023

Study information

• Verified date: April 2024
• Source: Biocon Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: September 19, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1. Able to understand and voluntarily provide written informed consent to participate in the study

2. Aged 18 to 75 years, inclusive, at the time of Screening

3. 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

4. Has stable disease for at least 2 months (i.e., without significant changes as defined by the principal investigator [PI] or designee)

5. Is a candidate for systemic therapy or phototherapy

6. 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)

7. Willing to follow the contraception requirement, based on the childbearing potential.

Exclusion Criteria:

Subjects must not be enrolled in the study if they meet any of the following criteria:

1. 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

2. 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:

3. 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

4. Other medical conditions: Known chronic or relevant acute TB

5. 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

6. 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

7. Has any active and serious infection or history of infections

8. 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

9. 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

1. Hemoglobin <9 g/dL

2. Platelet count <100 000/mm3

3. White blood cell count <3000 cells/mm3

4. 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)

5. Creatinine clearance <50 mL/min (Cockcroft Gault formula)

10. Has severe progressive or uncontrolled, clinically significant disease that in the judgment of the PI or designee renders the subject unsuitable for the study

11. Has moderate to severe heart failure (New York Heart Association [NYHA] Class III/IV)

12. Has a history of hypersensitivity to the active substance or to any of the excipients of Humira or Hulio

13. Is pregnant or nursing (lactating) woman

14. Has evidence (as assessed by the PI or designee using good clinical judgment) of alcohol or drug abuse or dependency up to 5 years prior to Screening

15. Is unable to follow study instructions and comply with the protocol in the opinion of the PI or designee.

Related Conditions & MeSH terms

• Moderate Chronic Plaque Psoriasis
• Psoriasis
• Severe Chronic Plaque Psoriasis

Intervention

Biological:
• Humira 40 MG in Prefilled Syringe
Humira (40 mg every other week)
• 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.

Locations

Country	Name	City	State
Bulgaria	Site 407 - Medical Centre "Asklepii", OOD	Dupnitsa
Bulgaria	Site 409 - Medical center Medconsult Pleven OOD	Pleven
Bulgaria	Site 403 - MC Rusemed ltd.	Ruse
Bulgaria	Site 406 - Medical Center Unimed Eood	Sevlievo
Bulgaria	Site 401 - Ambulatory for Specialized Medical Help - skin and venereal diseases	Sofia
Bulgaria	Site 402 - DCC "Alexandrovska", EOOD	Sofia
Bulgaria	Site 404 - DCC Focus 5 - MEOH OOD	Sofia
Bulgaria	Site 405 - Medical Center Hera EOOD	Sofia
Bulgaria	Site 408 - DCC "Alexandrovska", EOOD	Sofia
Bulgaria	Site 410 - DCC XXVIII	Sofia
Czechia	Site 304 - CCR Ostrava s.r.o.	Ostrava
Czechia	Site 303 - CCR Czech, a.s.	Pardubice
Czechia	Site 301 - Kozni Ambulance Fialova s.r.o.	Praha
Czechia	Site 302 - CLINTRIAL s.r.o.	Praha
Estonia	Site 203 - North Estonia Medical Centre Foundation	Talinn
Estonia	Site 201 - Tartu University Hospital	Tartu
Estonia	Site 204 - Clinical Research Centre	Tartu
Estonia	Site 205 - OÜ Innomedica	Tartu
Poland	Site 104 - Clinic Med Daniluk, Nowak Spólka Jawna	Bialystok
Poland	Site 111 - SPECDERM POZNANSKA	Bialystok
Poland	Site 103 - Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz
Poland	Site 101 - Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spólka Partnerska	Elblag
Poland	Site 109 - Centrum Badan Klinicznych P.I. House Sp. z o.o.	Gdansk
Poland	Site 112 - CENTRUM MEDYCZNE ALL-MED	Kraków
Poland	Site 116 - FutureMeds Krakow	Kraków
Poland	Site 106 - ETG Lodz	Lódz
Poland	Site 108 - Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna	Lódz
Poland	Site 115 - ETG Lublin	Lublin
Poland	Site 120 - Twoja Przychodnia PCM	Posen
Poland	Site 113 - ai centrum medyczne sp. z o.o. sp.k.	Poznan
Poland	Site 118 - ETG Siedlce	Siedlce
Poland	Site 114 - ETG Skierniewice	Skierniewice
Poland	Site 105 - Twoja Przychodnia-Szczecinskie Centrum Medyczne	Szczecin
Poland	Site 107 - MICS Centrum Medyczne Warszawa	Warsaw
Poland	Site 110 - Clinical Research Group Sp. z o.o.	Warsaw
Poland	Site 117 - MCM POLIMEDICA	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Biocon Biologics Inc.	IQVIA Pvt. Ltd, MEDA Pharma GmbH & Co. KG, Mylan Inc.

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Estonia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoints: Pharmacokinetics (PK) - AUC	AUCt, 26-28 (Area under the adalimumab concentration-time curve [AUC] over the dosing interval of Week 26-28)	Week 26 - 28
Primary	Primary Endpoints: Pharmacokinetics (PK) - Cmax	Cmax, 26-28 (Maximum observed adalimumab concentration during the dosing interval Week 26-28).	Week 26 - 28