Plaque PsoriasisPhase 3NCT03849404
Efficacy, Safety, and Immunogenicity of AVT02 With Moderate-to-Severe Chronic Plaque Psoriasis
A Phase 3 study testing Adalimumab in people with Plaque Psoriasis, run by Alvotech Swiss AG at 20 sites in 4 countries.
Trial summary
Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 20 Feb 2019to 20 Jul 2020
- 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 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 BL.
- Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
- Patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB).
Who cannot join
- Patient has prior use of 2 or more biologics for treatment of PsO.
- 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 drug on 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 BL (Week 1).
- PUVA phototherapy and/or UVB phototherapy within 4 weeks prior to the BL Visit.
- Nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the BL Visit.
Show all 9Show fewer
- Any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational.
- Any systemic steroid in the 4 weeks prior to BL.
- Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened and randomized per the list in the protocol
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Poland10 sites
ClinicMed Daniluk, Nowak Spółka Jawna
Bialystok
NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik
Bialystok
Centrum Badań Klinicznych PI-House Sp. Z o.o.
Gdansk, 80-546
Synexus Polska Sp. z o.o. Oddział w Gdańsku
Gdansk
Center Med Kraków Sp. Z o.o.
Krakow
Centrum Medyczna ALL-MED
Lodz
NZOZ "Nasz Lekarz" Sławomir Jeka, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną
Torun
Synexus Polska Sp. z o.o.Oddział w Warszawie
Warsaw
DermMedica Sp. z o.o.
Wroclaw
Synexus Polska Sp. z o.o. Oddział we Wrocławiu
Wroclaw
Georgia5 sites
Aleksandre Aladashvili Clinic LLC
Tbilisi, 0102
The first University Clinic of Tbilisi State Medical University
Tbilisi, 0141
Scientific Research National Center of Dermatology and Venereology LLC
Tbilisi, 0159
Health Institute LLC
Tbilisi, 0160
David Abuladze Georgian-Italian Clinic LTD
Tbilisi, 0179
Estonia4 sites
Innomedica OU
Tallinn, 10117
OU Vahlberg & Pild
Tallinn, 10134
North Estonia Medical Centre Foundation, Dermatovenerology Centre
Tallinn, 13419
Tartu University Hospital, Dermatology Clinic
Tartu, 50406
Ukraine1 site
Zaporizhzhya Regional Dermatology and Venereology Clinical Dispensary
Zaporizhzhya
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)
Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.
Read the detailed description
A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS).
This study will be conducted at about 40 study centers in central and eastern European countries. A contract research organization, will oversee operational aspects of this study on behalf of Alvotech Swiss AG (Alvotech), the Sponsor of the study.
- Conditions
- Plaque Psoriasis
- Being tested
- Adalimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Patients in AVT02 arm will receive an initial loading dose of AVT02 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) starting 1 week after the loading dose, and will continue to receive AVT02 until Week 48 Patients in EU-Humira arm will receive an initial loading dose of Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW starting 1 week after the loading dose and will continue to receive Humira until Week 48
| Study group | Role | What they receive |
|---|---|---|
| AVT02 100mg/mL (Adalimumab Biosimilar) | Experimental | Patients will be randomized to AVT02 on 1: 1 basis from the dosing day of Day 1 until week 48 Receives: Biological: Adalimumab |
| EU-Humira 100mg/mL (Adalimumab Originator) | Experimental | Patients will be randomized to EU-Humira on 1: 1 basis from the dosing day of Day 1 until week 48 Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index (PASI)
Percent (%) change in Psoriasis Area and Severity Index (PASI)
Measured: Baseline to Week 16
Secondary outcomes (1)
Psoriasis Area and Severity Index (PASI)
Percent (%) change in Psoriasis Area and Severity Index (PASI)
Measured: Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start20 Feb 2019
- Primary completion23 Dec 2019
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvotech Swiss AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849404
- Sponsor's protocol ID
- AVT02-GL-301
- Status last verified
- Dec 2019
- First submitted
- 5 Feb 2019
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Feldman SR, Reznichenko N, Pulka G, Kingo K, George Galdava, Berti F, Sobierska J, Dias R, Guenzi E, Hendrik Otto, Haliduola HN, Kay R, Stroissnig H. Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study. BioDrugs. 2021 Nov;35(6):735-748. doi: 10.1007/s40259-021-00502-w. Epub 2021 Oct 16.
PubMed 34657274
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients With Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS)
- ClinicalTrials.gov ID
- NCT03849404
- Acronym / sponsor ID
- AVT02-GL-301
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Alvotech Swiss AGIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Efficacy study of AVT02 (Alvotech Biosimilar to Adalimumab), in patients with moderate to severe plaque psoriasis.
Detailed description
A Multicenter, Double-blind, Randomized, Parallel-group, Active Control Study to Compare the Efficacy, Safety, and Immunogenicity of AVT02 Versus Humira® in Patients with Moderate-to-Severe Chronic Plaque Psoriasis (ALVOPAD PS).
This study will be conducted at about 40 study centers in central and eastern European countries. A contract research organization, will oversee operational aspects of this study on behalf of Alvotech Swiss AG (Alvotech), the Sponsor of the study.
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 |
|---|---|---|
| AVT02 100mg/mL (Adalimumab Biosimilar) | Experimental | Biological: AdalimumabPatients will be randomized to AVT02 on 1: 1 basis from the dosing day of Day 1 until week 48 |
| EU-Humira 100mg/mL (Adalimumab Originator) | Experimental | Biological: AdalimumabPatients will be randomized to EU-Humira on 1: 1 basis from the dosing day of Day 1 until week 48 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient 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 BL.
- Patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the Investigator or designee).
- Patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light A (PUVA), and ultraviolet light B (UVB).
Key exclusion criteria (9 listed)
- Patient has prior use of 2 or more biologics for treatment of PsO.
- 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 drug on psoriasis.
- Patient has prior use of any of the following medications within specified time periods or will require use during the study:
- Note: Only key inclusion/exclusion criteria mentioned here. Patients will be screened and randomized per the list in the protocol
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 |
|---|---|---|
| AdalimumabPatients in AVT02 arm will receive an initial loading dose of AVT02 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) starting 1 week after the loading dose, and will continue to receive AVT02 until Week 48 Patients in EU-Humira arm will receive an initial loading dose of Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW starting 1 week after the loading dose and will continue to receive Humira until Week 48 | Biological | AVT02 100mg/mL (Adalimumab Biosimilar), EU-Humira 100mg/mL (Adalimumab Originator) |
Primary outcome
Psoriasis Area and Severity Index (PASI)
Time frame: Baseline to Week 16
Percent (%) change in Psoriasis Area and Severity Index (PASI)
1 secondary outcome
Psoriasis Area and Severity Index (PASI)
Time frame: Percent improvement in PASI from BL to Week 8, 12, 24, 32, 42, and 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Derived from this study: PubMed 34657274Feldman SR, Reznichenko N, Pulka G, Kingo K, George Galdava, Berti F, Sobierska J, Dias R, Guenzi E, Hendrik Otto, Haliduola HN, Kay R, Stroissnig H. Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study. BioDrugs. 2021 Nov;35(6):735-748. doi: 10.1007/s40259-021-00502-w. Epub 2021 Oct 16.
- Individual participant dataSharing planned: Undecided
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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.
Steven Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
20 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 Adalimumab in people with Plaque Psoriasis, run by Alvotech Swiss AG at 20 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 3 inclusion and 9 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Poland, Georgia, Estonia, Ukraine. 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?
Psoriasis Area and Severity Index (PASI) (time frame: Baseline to Week 16). 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 NCT03849404, 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 28 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.