Clinical trial NCT05637515: Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate Chronic Plaque Psoriasis
Severe Chronic Plaque Psoriasis
Keywords: adalimumab
pharmacokinetics
plaque psoriasis
Lead sponsor: Biocon Limited
Sponsor class: INDUSTRY
Collaborators: name: Mylan Inc.
name: MEDA Pharma GmbH & Co. KG
name: IQVIA Pvt. Ltd
First posted: 2022-12-05
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Primary Endpoints: Pharmacokinetics (PK) - AUC
timeFrame: Week 26 - 28
measure: Primary Endpoints: Pharmacokinetics (PK) - Cmax
timeFrame: Week 26 - 28
Secondary outcomes:
Other outcomes:
Locations:
city: Dupnitsa
country: Bulgaria
facility: Site 407 - Medical Centre "Asklepii", OOD
city: Pleven
country: Bulgaria
facility: Site 409 - Medical center Medconsult Pleven OOD
city: Ruse
country: Bulgaria
facility: Site 403 - MC Rusemed ltd.
city: Sevlievo
country: Bulgaria
facility: Site 406 - Medical Center Unimed Eood
city: Sofia
country: Bulgaria
facility: Site 401 - Ambulatory for Specialized Medical Help - skin and venereal diseases
city: Sofia
country: Bulgaria
facility: Site 402 - DCC "Alexandrovska", EOOD
city: Sofia
country: Bulgaria
facility: Site 404 - DCC Focus 5 - MEOH OOD
city: Sofia
country: Bulgaria
facility: Site 405 - Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Site 408 - DCC "Alexandrovska", EOOD
city: Sofia
country: Bulgaria
facility: Site 410 - DCC XXVIII
city: Ostrava
country: Czechia
facility: Site 304 - CCR Ostrava s.r.o.
city: Pardubice
country: Czechia
facility: Site 303 - CCR Czech, a.s.
city: Praha
country: Czechia
facility: Site 301 - Kozni Ambulance Fialova s.r.o.
city: Praha
country: Czechia
facility: Site 302 - CLINTRIAL s.r.o.
city: Talinn
country: Estonia
facility: Site 203 - North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Site 201 - Tartu University Hospital
city: Tartu
country: Estonia
facility: Site 204 - Clinical Research Centre
city: Tartu
country: Estonia
facility: Site 205 - OÜ Innomedica
city: Białystok
country: Poland
facility: Site 104 - Clinic Med Daniluk, Nowak Spółka Jawna
city: Białystok
country: Poland
facility: Site 111 - SPECDERM POZNANSKA
city: Bydgoszcz
country: Poland
facility: Site 103 - Centrum Medyczne Pratia Bydgoszcz
city: Elbląg
country: Poland
facility: Site 101 - Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska
city: Gdańsk
country: Poland
facility: Site 109 - Centrum Badan Klinicznych P.I. House Sp. z o.o.
city: Kraków
country: Poland
facility: Site 112 - CENTRUM MEDYCZNE ALL-MED
city: Kraków
country: Poland
facility: Site 116 - FutureMeds Krakow
city: Lublin
country: Poland
facility: Site 115 - ETG Lublin
city: Posen
country: Poland
facility: Site 120 - Twoja Przychodnia PCM
city: Poznań
country: Poland
facility: Site 113 - ai centrum medyczne sp. z o.o. sp.k.
city: Siedlce
country: Poland
facility: Site 118 - ETG Siedlce
city: Skierniewice
country: Poland
facility: Site 114 - ETG Skierniewice
city: Szczecin
country: Poland
facility: Site 105 - Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Warsaw
country: Poland
facility: Site 107 - MICS Centrum Medyczne Warszawa
city: Warsaw
country: Poland
facility: Site 110 - Clinical Research Group Sp. z o.o.
city: Warsaw
country: Poland
facility: Site 117 - MCM POLIMEDICA
city: Łódź
country: Poland
facility: Site 106 - ETG Lodz
city: Łódź
country: Poland
facility: Site 108 - Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna
Study officials:
References: