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

PHASE3CompletedINTERVENTIONAL
Enrollment

374

Participants

Timeline

Start Date

November 21, 2022

Primary Completion Date

September 19, 2023

Study Completion Date

September 19, 2023

Conditions
Moderate Chronic Plaque PsoriasisSevere Chronic Plaque Psoriasis
Interventions
BIOLOGICAL

Humira 40 MG in Prefilled Syringe

Humira (40 mg every other week)

BIOLOGICAL

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."

Trial Locations (36)

Unknown

"Site 407 - Medical Centre Asklepii, OOD", Dupnitsa

Site 409 - Medical center Medconsult Pleven OOD, Pleven

Site 403 - MC Rusemed ltd., Rousse

Site 406 - Medical Center Unimed Eood, Sevlievo

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

"Site 402 - DCC Alexandrovska, EOOD", Sofia

Site 404 - DCC Focus 5 - MEOH OOD, Sofia

Site 405 - Medical Center Hera EOOD, Sofia

"Site 408 - DCC Alexandrovska, EOOD", Sofia

Site 410 - DCC XXVIII, Sofia

Site 304 - CCR Ostrava s.r.o., Ostrava

Site 303 - CCR Czech, a.s., Pardubice

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

Site 302 - CLINTRIAL s.r.o., Prague

Site 203 - North Estonia Medical Centre Foundation, Talinn

Site 201 - Tartu University Hospital, Tartu

Site 204 - Clinical Research Centre, Tartu

Site 205 - OÜ Innomedica, Tartu

Site 104 - Clinic Med Daniluk, Nowak Spółka Jawna, Bialystok

Site 111 - SPECDERM POZNANSKA, Bialystok

Site 103 - Centrum Medyczne Pratia Bydgoszcz, Bydgoszcz

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

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

Site 112 - CENTRUM MEDYCZNE ALL-MED, Krakow

Site 116 - FutureMeds Krakow, Krakow

Site 106 - ETG Lodz, Lodz

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

Site 115 - ETG Lublin, Lublin

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

Site 120 - Twoja Przychodnia PCM, Poznan

Site 118 - ETG Siedlce, Siedlce

Site 114 - ETG Skierniewice, Skierniewice

Site 105 - Twoja Przychodnia-Szczecinskie Centrum Medyczne, Szczecin

Site 107 - MICS Centrum Medyczne Warszawa, Warsaw

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

Site 117 - MCM POLIMEDICA, Warsaw

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mylan Inc.

INDUSTRY

collaborator

MEDA Pharma GmbH & Co. KG

INDUSTRY

collaborator

IQVIA Pvt. Ltd

INDUSTRY

lead

Biocon Biologics Inc.

INDUSTRY

NCT05637515 - Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity | Biotech Hunter | Biotech Hunter