Plaque PsoriasisPhase 3NCT06005532
Study Evaluation of the Efficacy, Safety and Immunogenicity of Adalimumab in Comparison With Humira®
A Phase 3 study testing Adalimumab and Humira in people with Plaque Psoriasis, run by Mabscale, LLC at 9 sites in Russia.
Trial summary
MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Adalimumab and Humira
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 9 sitesRussia
- Study dates
- 2 Oct 2023to Dec 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
- Established clinical diagnosis plaque psoriasis, lasting at least 6 months before the screening.
- Plaque psoriasis of moderate or severe severity of stable course with:
- PASI ≥ 12 points;
- BSA ≥ 10 %;
- sPGA ≥ 3 points.
- Patients who have been shown to undergo systemic therapy and/or patients who have had insufficient therapeutic efficacy of at least 1 previous standard systemic therapy for psoriasis, including phototherapy, therapy with cytostatic and immunosuppressive drugs, or who have had intolerance to standard systemic therapy.
Who cannot join
- Data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations.
- A history of severe hypersensitivity reactions of any etiology.
- Other (other than plaque) forms of psoriasis.
- Drug-induced psoriasis.
- Data on the use of the Adalimumab or any preparations of monoclonal antibodies inhibiting TNF-α at any time during life.
- The presence of Adalimumab antibodies.
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- Extensive surgical intervention performed less than 30 days before the screening period, or planned extensive surgical intervention during the study period.
- Active or latent tuberculosis
- Lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases or a history of multiple myeloma.
- Any other malignant neoplasms currently or in anamnesis within the last 5 years, with the exception of completely removed and/or cured.
- Confirmed coronavirus infection caused by COVID-19 within 8 weeks prior to the screening period.
- Anamnestic data on the presence of syphilis, viral hepatitis B, viral hepatitis C, HIV.
- Vaccination with live or attenuated vaccines within 8 weeks before the screening period.
- Hepatic and/or renal insufficiency.
- Pregnancy or lactation.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites, 9 recruiting
- Recruiting
Regional dermatovenerologic dispensary
Barnaul
Kovaleva
- Recruiting
Chelyabinsk Regional Clinical Dermatovenerologic Dispensary
Chelyabinsk
Ziganshin
- Not yet recruiting
Interregional Clinical Diagnostic Center
Kazan'
Isaeva
- Not yet recruiting
City clinical hospital n.a.Botkin
Moscow
Sotnikova
- Not yet recruiting
Rheumatology research Instititue n.a.Nasonova
Moscow
Korsakova
- Not yet recruiting
State Scientific Center of Dermatovenerology and Cosmetology
Nizhny Novgorod
Gorodnichev
- Not yet recruiting
Reafan
Novosibirsk
Filippova
- Not yet recruiting
New Clinic
Pyatigorsk
Chistyakova
- Not yet recruiting
Dermatovenerologic dispensary N10
Saint Petersburg
Sukharev
About this study
Official title: Randomized Double Blind Phase III Trial Comparative Clinical Safety, Efficacy and Immunogenicity of Adalimumab (Manufactured by Mabscale, LLC) to Humira®.
MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®.
The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.
Read the detailed description
Adalimumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients with chronic plaque psoriasis.
This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.
- Conditions
- Plaque Psoriasis
- Being tested
- Adalimumab, Humira
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Adalimumab injection 40 mg / 0.8 ml
HumiraDrug
Adalimumab injection 40 mg / 0.4 ml
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab (manufactured by Mabscale, LLC) | Experimental | In the main period, patients will begin Visit 1 receiving Adalimumab therapy at an initial dose (80 /0, 16 ml) on Visit 1, from Visit 2 Adalimumab therapy at a maintenance dose (40 /0, 8 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days. In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 8 ml)) every 2 weeks until the end of a trial. Receives: Drug: Adalimumab |
| Humira® | Active comparator | In the main period, patients will begin Visit 1 receiving Humira® therapy at an initial dose (80 /0, 8 ml) on Visit 1, from Visit 2 Humira® therapy at a maintenance dose (40 /0, 4 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days.
In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 4 ml)) every 2 weeks until the end of a trial. Receives: Drug: Humira |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieved a response according to the PASI criterion of 75 (a decrease in the severity and prevalence of psoriasis by ≥75% from the baseline level assessed by the PASI index)
Measured: after 16 weeks of therapy (assessment at Visit 10)
Proportion of patients with positive antibody titer to Adalimumab
Measured: 51 weeks of therapy
Percentage of patients who have neutralizing antibodies to Adalimumab
Measured: 51 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start2 Oct 2023
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabscale, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005532
- Sponsor's protocol ID
- MABPS-3/2020
- Status last verified
- Nov 2023
- First submitted
- 5 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Phase III Trial Comparative Clinical Safety, Efficacy and Immunogenicity of Adalimumab (Manufactured by Mabscale, LLC) to Humira®.
- ClinicalTrials.gov ID
- NCT06005532
- Acronym / sponsor ID
- MABPS-3/2020
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Mabscale, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Aug 2023 (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.
MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®.
The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.
Detailed description
Adalimumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Humira®, which is approved as treatment in patients with chronic plaque psoriasis.
This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab (manufactured by Mabscale, LLC) | Experimental | Drug: AdalimumabIn the main period, patients will begin Visit 1 receiving Adalimumab therapy at an initial dose (80 /0, 16 ml) on Visit 1, from Visit 2 Adalimumab therapy at a maintenance dose (40 /0, 8 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days. In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 8 ml)) every 2 weeks until the end of a trial. |
| Humira® | Active comparator | Drug: HumiraIn the main period, patients will begin Visit 1 receiving Humira® therapy at an initial dose (80 /0, 8 ml) on Visit 1, from Visit 2 Humira® therapy at a maintenance dose (40 /0, 4 ml) for up to Visit 9 of therapy. Each visit is conducted every two weeks ± 2 days. In additional period (from Visit 11 until Visit 28), eligible patients will continue to receive treatment after additional randomization (Adalimumab or Humira® (40 /0, 4 ml)) every 2 weeks until the end of a trial. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent.
- Male and female patients aged 18-65 years, body weight ≥ 50 kg and ≤ 120 kg.
- Established clinical diagnosis plaque psoriasis, lasting at least 6 months before the screening.
- Plaque psoriasis of moderate or severe severity of stable course with:
- Patients who have been shown to undergo systemic therapy and/or patients who have had insufficient therapeutic efficacy of at least 1 previous standard systemic therapy for psoriasis, including phototherapy, therapy with cytostatic and immunosuppressive drugs, or who have had intolerance to standard systemic therapy.
Key exclusion criteria (15 listed)
- Data on intolerance or hypersensitivity to any components of the drugs, or to any other human proteins, immunoglobulin preparations.
- A history of severe hypersensitivity reactions of any etiology.
- Other (other than plaque) forms of psoriasis.
- Drug-induced psoriasis.
- Data on the use of the Adalimumab or any preparations of monoclonal antibodies inhibiting TNF-α at any time during life.
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 |
|---|---|---|
| AdalimumabAdalimumab injection 40 mg / 0.8 ml | Drug | Adalimumab (manufactured by Mabscale, LLC) |
| HumiraAdalimumab injection 40 mg / 0.4 ml | Drug | Humira® |
Primary outcome
The proportion of patients who achieved a response according to the PASI criterion of 75 (a decrease in the severity and prevalence of psoriasis by ≥75% from the baseline level assessed by the PASI index)
Time frame: after 16 weeks of therapy (assessment at Visit 10)
Proportion of patients with positive antibody titer to Adalimumab
Time frame: 51 weeks of therapy
Percentage of patients who have neutralizing antibodies to Adalimumab
Time frame: 51 weeks of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab and Humira in people with Plaque Psoriasis, run by Mabscale, LLC at 9 sites in Russia.
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 15 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: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yulia BASKAEVA (+74997149289, baskaeva.y@benerix.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who achieved a response according to the PASI criterion of 75 (a decrease in the severity and prevalence of psoriasis by ≥75% from the baseline level assessed by the PASI index) (time frame: after 16 weeks of therapy (assessment at Visit 10)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.