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Plaque PsoriasisPhase 3NCT04453137

Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis

A Phase 3 study testing Adalimumab originator and Adalimumab biosimilar in people with Plaque Psoriasis, run by Alvotech Swiss AG at 25 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Adalimumab originator and Adalimumab biosimilar
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
567 participants
Where
25 sitesin 5 countries
Study dates
30 Jun 2020to 16 Nov 2021
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Patient has signed the informed consent form and documentation as required by relevant competent authorities and is able to understand and adhere to the visit schedule and study requirements.
  • Patient is male or female aged 18 to 75 years, inclusive, at the time of Screening.
  • Patients with moderate-to-severe chronic plaque psoriasis who has involved body surface area (BSA) ≥ 10% (Palm Method), ≥ 12 on the PASI, and static Physicians Global Assessments (sPGA) ≥ 3 (moderate) at Screening and at Baseline (Week 1/Day 1).
  • Patient has had stable disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
  • Patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
  • Patient is naive to adalimumab therapy, approved or investigational.
Show all 13Show fewer
  • Patient has a negative QuantiFERON test for tuberculosis (TB) during Screening. Note: Patients with an indeterminate QuantiFERON test are allowed if they have all of the following:
  • No evidence of active TB on chest radiograph within 3 months prior to the first dose of study drug.
  • Documented history of treatment of TB or adequate prophylaxis initiation with an isoniazid-based regimen > 1 month prior to receiving study drug in accordance with local recommendations.
  • No known exposure to active TB after most recent prophylaxis.
  • Asymptomatic at Screening and Baseline. Investigators should check with the medical monitor before enrolling such subjects.
  • Women of childbearing potential (except those who are postmenopausal for more than 2 years or if surgically sterile) must have a negative serum pregnancy test during Screening and negative urine pregnancy test at Baseline (Week 1/Day 1).
  • Sexually active women of childbearing potential must agree to use highly effective contraception (sterilization, hormonal contraception pills or injection or implants, sterilization and abstinence) for the duration of the study and until 6 months after the last dose of the study drug. Male patients must agree to use contraception for the duration of the study and agree not to donate sperm during and for 6 months after the last dose of study drug.

Who cannot join

  • Patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, 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.
  • Patient has prior use of any of the following medications within specified time periods or will require use during the study:
  • Topical medications within 2 weeks of Baseline (Week 1/Day 1). PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the Baseline (Week 1/Day 1).
  • Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the Baseline (Week 1/Day 1).
  • Any prior or concomitant adalimumab therapy, either approved or investigational.
  • Any systemic steroid in the 4 weeks prior to Screening.
Show all 44Show fewer
  • Investigational agent(s) within 90 days or 5 half-lives (whichever is longer) before Baseline (Week 1/Day 1) (Refer to the following table for approved/marketed products).
  • Specified washout periods are as follows:
  • Adalimumab: not allowed
  • Alefacept, Briakinumab, Brodalumab, Golimumab: 24 weeks
  • Ustekinumab: 15 weeks
  • Etanercept , Secukinumab , Infliximab , Certolizumab, Pegol: 12 weeks
  • Cyclosporine: 4 weeks
  • Methotrexate: 4 weeks
  • PUVA-UVA/UVB: 4 weeks
  • Oral retinoid: 4 weeks
  • Corticosteroids IM - IV - oral - intra-articular for psoriatic arthritis: 4 weeks
  • Topical psoriasis treatments (except in face, eyes, scalp, palms, soles, and genital area and except only mild potency steroids in these areas): 2 weeks
  • Patient has received live or attenuated vaccines during the 4 weeks prior to Screening or intends to receive a live or attenuated vaccine at any time during the study.
  • Patient 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 Investigator or designee, significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
  • Patient has a planned surgical intervention during the duration of the study and which, in the opinion of the Investigator or designee, will put the subject at further risk or hinder the patient's ability to maintain compliance with study treatment and the visit schedule.
  • Has any active and serious infection or history of infections as follows:
  • Any active infection:
  • For which non-systemic anti-infective were used within 4 weeks prior to randomization. Note: patients receiving topical antibiotics for facial acne do not need to be excluded.
  • Which required hospitalization or systemic anti-infective within 8 weeks prior to randomization.
  • Recurrent or chronic infections or other active infection that, in the opinion of the Investigator or designee, might cause this study to be detrimental to the subject.
  • Invasive fungal infection or mycobacterial infection.
  • Opportunistic infections, such as listeriosis, legionellosis, or pneumocystis.
  • Patient is positive for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B surface antigen (HBsAg) and/or is positive for hepatitis B core antibody.
  • Patient has severe progressive or uncontrolled, clinically significant disease that in the judgment of the Investigator or designee renders the subject unsuitable for the study.
  • Patient has a history of malignancy within 5 years except for adequately treated cutaneous squamous or basal cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma.
  • Patient has an active neurological disease, such as multiple sclerosis, Guillain-Barré syndrome, optic neuritis, and transverse myelitis, or a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
  • Patient has moderate to severe heart failure (New York Heart Association [NYHA] Class III/IV).
  • Patient has a history of hypersensitivity to the active substance or to any of the excipients of Humira or AVT02.
  • Patient is pregnant or nursing (lactating) woman, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
  • Patient exhibits evidence (as assessed by the Investigator or designee using good clinical judgment) of active substance abuse (alcohol or drugs) within 6 months of Screening that may impact patient's ability to participate in the study.
  • Is unable to follow study instructions and comply with the protocol in the opinion of the Investigator or designee.
  • Patient has a history of clinically significant hematological abnormalities, including cytopenias (eg, thrombocytopenia, leukopenia).
  • Has a laboratory abnormality that, in the opinion of the Investigator or designee, could cause this study to be detrimental to the subject. The following laboratory abnormalities should be carefully considered:
  • 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 at least on 2 occasions separated by a number of days).
  • Creatinine clearance < 50 mL/min (Cockcroft-Gault formula).

Trial locations and contacts

25 sites in 5 countries.

25 sites in 5 countries

Poland7 sites

  • Alvotech Swiss AG - Site 4803

    Gdansk

  • Alvotech Swiss AG - Site 4804

    Krakow

  • Alvotech Swiss AG - Site 4807

    Krakow

  • Alvotech Swiss AG - Site 4805

    Lodz

  • Alvotech Swiss AG - Site 4806

    Torun

  • Wromedica Centrum Zdrowia

    Wroclaw, 51-685

  • Alvotech Swiss AG - 4808

    Wroclaw

Other trials in Poland

Ukraine7 sites

  • Alvotech Swiss AG - Site 3805

    Kharkiv

  • Alvotech Swiss AG - Site 3807

    Kharkiv

  • Alvotech Swiss AG - Site 3801

    Kyiv

  • Alvotech Swiss AG - Site 3806

    Kyiv

  • Alvotech Swiss Ag - Site 3802

    Rivne

  • Alvotech Swiss AG - Site 3804

    Uzhhorod

  • Alvotech Swiss AG - Site 3803

    Zaporizhzhya

Other trials in Ukraine

Russia6 sites

  • Alvotech Swiss AG - Site 7001

    Kemerovo

  • Alvotech Swiss AG - Site 7005

    Krasnodar

  • Alvotech Swiss AG - Site 7003

    Saint Petersburg

  • Alvotech Swiss AG - Site 7004

    Saint Petersburg

  • Alvotech Swiss AG - Site 7006

    Saint Petersburg

  • Alvotech Swiss AG - Site 7002

    Saratov

Other trials in Russia

Georgia4 sites

  • 9901

    Tbilisi

  • Alvotech Swiss AG - 9904

    Tbilisi

  • Alvotech Swiss AG - Site 9902

    Tbilisi

  • Alvotech Swiss AG - Site 9903

    Tbilisi

Other trials in Georgia

Iceland1 site

  • Alvotech Swiss AG - Site 3501

    Reykjavik

Other trials in Iceland

About this study

Official title: Multicenter, Double-Blind, Randomized, Parallel-group, Study Evaluating PK, Efficacy, Safety, and Immunogenicity in Patients With Plaque Psoriasis Receiving Humira® or AVT02 Followed by a Safety Extension Phase of AVT02

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis

Read the detailed description

This is a multicenter, randomized, double-blind, parallel-group study to evaluate PK, efficacy, safety, and immunogenicity between patients with moderate to severe chronic plaque psoriasis receiving Humira and patients with moderate to severe chronic plaque psoriasis undergoing repeated switches between Humira and AVT02, followed by an optional safety Extension Phase.

AVT02-GL-302 study is composed of 3 parts:

LeadIn Period: Week 1-12 - OpenLabel Treatment Switching Module: Week 12-28 - DoubleBlind Treatment Optional Extension Phase: Week 28-52 - OpenLabel Treatment

Lead-In Period:

After successfully completing Screening activities, patients will be enrolled in the LeadIn Period.

During the LeadIn Period, patients will receive Humira (initial dose of 80 mg [2 × 40 mg] administered subcutaneously [SC], followed by 40 mg SC given every other week starting 1 week after the initial dose). At Week 12, responsive patients (Psoriasis Area and Severity Index [PASI] ≥ 75 [PASI75]) will be randomly assigned in a 1:1 ratio to either of the following groups for participation in the Double-Blind Switching Module.

Switching Module:

Group 1: patients undergo repeated switches (Sw) of AVT02 and Humira from Week 12 until Week 26:

Sw1-AVT02 (40 mg every other week) for 4 weeks (2 injections), Sw2-Humira (40 mg every other week) for 4 weeks (2 injections), Sw3-AVT02 (40 mg every other week) for 8 weeks (4 injections). Group 2: patients continue to receive Humira 40 mg every other week from Week 12 until Week 26 (8 injections) The last study treatment administration in the Double-Blind Switching Module is at Week 26. The last study assessment is at Week 28 for both groups. The end-of-study (EoS) visit for the interchangeability (IC) part of study is planned at Week 28 (ie, 2 weeks after the last study treatment administration, EoS IC).

Extension Phase:

At Week 28, after the EoS IC visit, responsive patients (PASI ≥ 50 [PASI50]) will be offered to continue with the optional open-label Extension Phase (Weeks 28 to 52). AVT02 40 mg will be administered every other week starting from Week 28 (after completing EoS IC assessments), ending with the final study drug administration at Week 50. The EoS visit is planned for Week 52.

The clinical study report (CSR) for the IC part of the study will include the data from the OpenLabel Lead-In Period and Double-Blind Switching Module.

The Extension Phase CSR will include the data from the additional 24-week Open-Label Extension Phase (Weeks 28 to 52).

Being tested
Adalimumab originator, Adalimumab biosimilar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalimumab originatorBiological

    Also called Humira

    Subcutaneous injection every other week

  • Adalimumab biosimilarBiological

    Also called AVT02

    Subcutaneous injection every other week

Study groups in NCT04453137
Study groupRoleWhat they receive
Humira 40 mg/mL (Adalimumab Originator)Active comparatorDuring the LeadIn Period, patients will receive Humira (initial dose of 80 mg [2 × 40 mg] administered subcutaneously [SC], followed by 40 mg SC given every other week starting 1 week after the initial dose). At Week 12, responsive patients (Psoriasis Area and Severity Index [PASI] ≥ 75 [PASI75]) will be randomly assigned in a 1:1 ratio to either of the following groups for participation in the Double-Blind Switching Module.
Receives: Biological: Adalimumab originator
IC - Humira 40 mg/mL (Adalimumab Originator)Active comparatorpatients continue to receive Humira 40 mg every other week from Week 12 until Week 26 (8 injections)
Receives: Biological: Adalimumab originator
IC - Humira/AVT02 40 mg/mL (Adalimimab Biosimilar)Experimentalpatients undergo repeated switches (Sw) of AVT02 and Humira from Week 12 until Week 26: * Sw1-AVT02 (40 mg every other week) for 4 weeks (2 injections), * Sw2-Humira (40 mg every other week) for 4 weeks (2 injections), * Sw3-AVT02 (40 mg every other week) for 8 weeks (4 injections).
Receives: Biological: Adalimumab originator; Biological: Adalimumab biosimilar
AVT02 40 mg/mL (Adalimimab Biosimilar)ExperimentalAt Week 28, after the EoS IC visit, responsive patients (PASI ≥ 50 [PASI50]) will be offered to continue with the optional open-label Extension Phase (Weeks 28 to 52). AVT02 40 mg will be administered every other week starting from Week 28 (after completing EoS IC assessments), ending with the final study drug administration at Week 50. The EoS visit is planned for Week 52.
Receives: Biological: Adalimumab biosimilar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the concentration-time curve over the dosing interval from Week 26 to Week 28 (AUCtau,26-28)

    Venous blood samples will be collected for measurement of Area under the plasma concentration-time curve (AUCtau, 26-28) of AVT02 and Humira

    Measured: Week 26 to Week 28

  2. Maximum concentration over the dosing interval from Week 26 to Week 28 (Cmax, 26-28)

    Venous blood samples will be collected for measurement of serum concentration of AVT02 and Humira

    Measured: Week 26 to Week 28

Secondary outcomes (1)

  1. Psoriasis Area and severity index

    Percent (%) improvement of PASI from Week 1 to Week 28 and from Week 12 to Week 28

    Measured: Week 1 to Week 28 and week 12 to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2020
  2. Study start30 Jun 2020
  3. Primary completion31 May 2021
  4. Study completion16 Nov 2021

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open label lead-in phase, followed by blinded 1:1 randomization with open label extension phase.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04453137
Sponsor's protocol ID
AVT02-GL-302
Status last verified
May 2022
First submitted
15 May 2020
Last updated
4 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Feldman SR, Kay R, Reznichenko N, Sobierska J, Dias R, Otto H, Haliduola HN, Sattar A, Ruffieux R, Stroissnig H, Berti F. Assessing the Interchangeability of AVT02 and Humira(R) in Participants with Moderate-to-Severe Chronic Plaque Psoriasis: Pharmacokinetics, Efficacy, Safety, and Immunogenicity Results from a Multicenter, Double-Blind, Randomized, Parallel-Group Study. BioDrugs. 2023 Jul;37(4):551-567. doi: 10.1007/s40259-023-00600-x. Epub 2023 May 19.

    PubMed 37204631

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab originator and Adalimumab biosimilar in people with Plaque Psoriasis, run by Alvotech Swiss AG at 25 sites in 5 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 13 inclusion and 44 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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Poland, Ukraine, Russia, Georgia, Iceland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Area under the concentration-time curve over the dosing interval from Week 26 to Week 28 (AUCtau,26-28) (time frame: Week 26 to Week 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 NCT04453137, 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 4 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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