Moderate Chronic Plaque PsoriasisPhase 3NCT05637515
Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity
A Phase 3 study testing Humira 40 MG in Prefilled Syringe and Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe in people with Moderate Chronic Plaque Psoriasis and Severe Chronic Plaque Psoriasis, run by Biocon Biologics Inc. at 36 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis
- What is being tested?
- Humira 40 MG in Prefilled Syringe and Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 36 sitesin 4 countries
- Study dates
- 21 Nov 2022to 19 Sep 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- 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.
Who cannot join
- 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
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- 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)
- Has severe progressive or uncontrolled, clinically significant disease that in the judgment of the PI or designee renders the subject unsuitable for the study
- Has moderate to severe heart failure (New York Heart Association [NYHA] Class III/IV)
- Has a history of hypersensitivity to the active substance or to any of the excipients of Humira or Hulio
- Is pregnant or nursing (lactating) woman
- 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
- Is unable to follow study instructions and comply with the protocol in the opinion of the PI or designee.
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
Poland18 sites
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
Bulgaria10 sites
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
Czechia4 sites
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
Estonia4 sites
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
About this study
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)
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.
- Being tested
- Humira 40 MG in Prefilled Syringe, Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe
- Keywords
- adalimumab, pharmacokinetics, plaque psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Biological: Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints: Pharmacokinetics (PK) - AUC
AUCτ, 26-28 (Area under the adalimumab concentration-time curve [AUC] over the dosing interval of Week 26-28)
Measured: Week 26 - 28
Primary Endpoints: Pharmacokinetics (PK) - Cmax
Cmax, 26-28 (Maximum observed adalimumab concentration during the dosing interval Week 26-28).
Measured: Week 26 - 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start21 Nov 2022
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mylan Inc., MEDA Pharma GmbH & Co. KG, IQVIA Pvt. Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637515
- Sponsor's protocol ID
- ADA-IJZ-3001
- Other IDs
- 2021-006015-29
- Status last verified
- Oct 2024
- First submitted
- 23 Nov 2022
- Last updated
- 22 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 40493334
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05637515
- Acronym / sponsor ID
- ADA-IJZ-3001
- Keywords
- adalimumab, pharmacokinetics, plaque psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Biocon Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mylan Inc., MEDA Pharma GmbH & Co. KG, IQVIA Pvt. Ltd
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humira continuously | Active comparator | Biological: Humira 40 MG in Prefilled SyringeSubjects 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 |
| Repeated switches Humira - Hulio | Experimental | Biological: Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled SyringeSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humira 40 MG in Prefilled SyringeHumira (40 mg every other week) | Biological | Humira continuously |
| 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. | Biological | Repeated switches Humira - Hulio |
Primary outcome
Primary Endpoints: Pharmacokinetics (PK) - AUC
Time frame: Week 26 - 28
AUCτ, 26-28 (Area under the adalimumab concentration-time curve [AUC] over the dosing interval of Week 26-28)
Primary Endpoints: Pharmacokinetics (PK) - Cmax
Time frame: Week 26 - 28
Cmax, 26-28 (Maximum observed adalimumab concentration during the dosing interval Week 26-28).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40493334Deodhar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Humira 40 MG in Prefilled Syringe and Hulio 40 MG in Prefilled Syringe / Humira 40 MG in Prefilled Syringe in people with Moderate Chronic Plaque Psoriasis and Severe Chronic Plaque Psoriasis, run by Biocon Biologics Inc. at 36 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Poland, Bulgaria, Czechia, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoints: Pharmacokinetics (PK) - AUC (time frame: Week 26 - 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.