Plaque PsoriasisPhase 4NCT06336343
Bimekizumab in Plaque Psoriasis
A Phase 4 study testing Bimekizumab in people with Plaque Psoriasis, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Bimekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2024to 17 Mar 2026
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participant at least 18 years of age
- Participant is able to provide written informed consent and comply with the requirements of this study protocol.
- Participant has a BSA score of >3 prior to randomization.
- Participant has previously failed treatment with an IL-17or IL-23 agent, defined as previous treatment with either drug for at least 3 months without achieving a BSA ≤3.
- Participant's last dose with most recent IL-17 or IL-23 agent was at least 28 days prior to baseline visit.
- Participant who are women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and must be practicing an adequate and medically acceptable method of birth control for at least 30 days prior to Day 0 and at least 6 months after the last dose of study. Acceptable methods of birth control include intrauterine device (IUD) oral, transdermal, implanted or injected hormonal contraceptives (must have been initiated at least 1 month before entering the study); tubal ligation; abstinence; barrier methods with spermicide. If not of child-bearing potential, participants must have a sterile or vasectomized partner; have had a hysterectomy, a bilateral oophorectomy or be clinically diagnosed infertile; or be in a menopausal state for at least a year.
- Tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) negative at the time of screening, or if participant has a history of positive PPD or QuantiFERON, he/she has initiated or completed the appropriate treatment for latent tuberculosis.
- Participant is judged to be in good general health as determined by the principal investigator.
Who cannot join
- Have predominantly pustular, erythrodermic, and/or guttate forms of psoriasis.
- Have drug induced psoriasis
- History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at Screening. Participant with a positive or indeterminate PPD or QFT test must be assessed for evidence of active TB versus latent TB within 12 weeks prior to Baseline, including signs and symptoms and chest x-ray. If presence of latent tuberculosis is established, then treatment must have been initiated at least for 4 weeks prior to Baseline and completed. Participant with evidence of active TB may not be enrolled.
- Participants with a history of HIV, or history of hepatitis C or B infections.
- Use of any of the following therapies within 4 weeks prior to Baseline (Visit 2): systemic non-biologic psoriasis therapies, including, but not limited to: psoralens (topical or oral) and ultraviolet A (PUVA) therapy, cyclosporine, methotrexate, azathioprine, corticosteroids, apremilast, any JAK or TYK2 Inhibitors, oral retinoids, mycophenolate mofetil, sirolimus, 1, 25 dihydroxyvitamin D analogs, and other forms of phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing).
- Use of topical corticosteroids, topical calcineurin inhibitors, or other topical preparations with immunomodulatory properties within 2 weeks prior to Baseline (Visit 2).
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- Use of any investigational drug or any systemic drug for psoriasis within 4 weeks prior to Baseline (Visit 2).
- Serious concomitant illness that could require the use of systemic corticosteroids or otherwise interfere with the participant's participation in the trial.
- Myocardial infarction or stroke within the 6 months prior to Baseline (Visit 2).
- Clinically important deviation as judged by the investigator (such WBC< 3) from normal limits in physical examination, vital sign measurements, clinical laboratory tests results, and not associated with a chronic, well-controlled medical condition.
- Administration of any live vaccines 3 months prior to Baseline (Visit 2) and during the study.
- Have a current or history of lymphoproliferative disease within 5 years prior to Baseline (Visit 2); or have current or history of any malignant disease within 5 years prior to Baseline (Visit 2).
- History of suicide attempt, or are clinically judged by investigator to be at risk of suicide.
- History of IBD.
- Acute liver failure/cirrhosis.
- Had a serious infection, been hospitalized, or received IV antibiotics for an infection, within 12 weeks prior to Baseline (Visit 2).
- Known immunodeficiency, or history of infection typical of an immunocompromised host.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Windsor Dermatology - Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Study to Evaluate the Safety and Efficacy of Bimekizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17 or IL-23 Therapies
The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and 17F), which are known to increase inflammation. This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23.
Read the detailed description
This study will evaluate the safety and efficacy of bimekizumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17 or 23 therapies. Failure of IL-17 and/or IL-23 therapy will be defined as previous treatment with either secukinumab, ixekizumab, brodalumab, tildrakizumab, guselkumab, or risankizumab for at least 3 months without achieving PASI90 and a BSA >3%. Sixty patients will be enrolled in this 16-week open-label study. Patients will be enrolled at two different sites in the US.
After enrollment, study visits will occur at monthly intervals, with patients receiving bimekizumab 320 mg via subcutaneous injection at weeks 0, 4, 8, 12 and 16. At each visit, patients will be evaluated for change in PGA (Physician's Global Assessment), PASI score, BSA and any signs or symptoms of adverse events. Laboratory screening will include tests for tuberculosis. The primary efficacy endpoint will be the percentage of patients achieving BSA < 1 by week 16.
- Conditions
- Plaque Psoriasis
- Being tested
- Bimekizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BimekizumabDrug
Bimekizumab 320 mg via subcutaneous injections. Bimekizumab is a humanized immunoglobulin G1 monoclonal antibody that selectively binds to and neutralizes the biologic functions of both interleukin-17A (IL-17A) and IL-17F, which are known to increase inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with moderate-to-severe psoriasis | Experimental | Individuals with moderate-to-severe psoriasis who have failed similar therapies. Receives: Drug: Bimekizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Surface Area (BSA) of < 1
Body Surface Area (BSA) < 1 describes psoriasis affecting less than 1 percent of the body's surface. One hand covers roughly 1% of the body's surface area. Psoriasis affecting less than 3 percent BSA may be considered mild, 3 to 10 percent as moderate and more than 10 percent as severe.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Secondary outcomes (4)
Psoriasis and Severity Index Score (PASI) of < 1
The Psoriasis Area and Severity Index (PASI) measures psoriasis severity. PASI < 1 indicates almost clear to no psoriasis, based on skin area affected, erythema, induration, and desquamation. The full score ranges from 0 to 72, with higher scores indicating more severe psoriasis. Each body region (head, trunk, arms, legs) is scored 0 (no disease) to 6 (maximum score) for affected area and 0 (mild) to 4 (very severe) for erythema, induration, and desquamation. Higher scores indicate more severe psoriasis with a score of ≥10 generally defining moderate to severe disease.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Physician Global Assessment (PGA) of < 1
The Physician Global Assessment (PGA) is a severity assessment tool used to evaluate the overall lesional and non-lesional manifestations of psoriasis. PGA < 1 indicates almost clear to clear psoriasis, based on physical attributes of the lesional and non-lesional manifestations. It means there is no signs of psoriasis or normal to pink coloration, no thickening, and no to minimal scaling. The full PGA score ranges from 0 (clear) to 5 (severe disease), with higher scores indicating more severe psoriasis.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Psoriasis and Severity Index Score (PASI) of < 2
The Psoriasis Area and Severity Index (PASI) measures psoriasis severity. PASI < 2 indicates almost clear to no psoriasis, based on skin area affected, erythema, induration, and desquamation. The full score ranges from 0 to 72, with higher scores indicating more severe psoriasis. Each body region (head, trunk, arms, legs) is scored 0 (no disease) to 6 (maximum score) for affected area and 0 (mild) to 4 (very severe) for erythema, induration, and desquamation. Higher scores indicate more severe psoriasis with a score of ≥10 generally defining moderate to severe disease.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Physician Global Assessment (PGA) of < 2
The Physician Global Assessment (PGA) is a severity assessment tool used to evaluate the overall lesional and non-lesional manifestations of psoriasis. PGA < 2 indicates almost clear to clear psoriasis, based on physical attributes of the lesional and non-lesional manifestations. It means there is no signs of psoriasis or normal to pink coloration, no thickening, and no to minimal scaling. The full PGA score ranges from 0 (clear) to 5 (severe disease), with higher scores indicating more severe psoriasis.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start3 Jun 2024
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma, Psoriasis Treatment Center of Central New Jersey
- Responsible party
- Principal investigator, Mark Lebwohl, Icahn School of Medicine at Mount Sinai
- Investigators
- Mark Lebwohl, MD, Principal investigator, Ichan School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336343
- Sponsor's protocol ID
- STUDY-23-01698
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be provided as aggregated data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of Bimekizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed IL-17 or IL-23 Therapies
- ClinicalTrials.gov ID
- NCT06336343
- Acronym / sponsor ID
- STUDY-23-01698
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- UCB Pharma, Psoriasis Treatment Center of Central New Jersey
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 28 Mar 2024 (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.
The purpose of this research study is to evaluate the effectiveness and safety of bimekizumab in individuals with moderate-to-severe psoriasis who have failed similar therapies. Bimekizumab improves psoriasis by suppressing a type of substance found in bodies called interleukins (specifically, interleukins 17a and 17F), which are known to increase inflammation. This study will look at the effectiveness of bimekizumab in psoriasis patients that have failed previous therapies that target interleukin IL-17A or 23.
Detailed description
This study will evaluate the safety and efficacy of bimekizumab in the treatment of moderate-to-severe psoriasis in patients who have previously failed treatment with interleukin (IL)-17 or 23 therapies. Failure of IL-17 and/or IL-23 therapy will be defined as previous treatment with either secukinumab, ixekizumab, brodalumab, tildrakizumab, guselkumab, or risankizumab for at least 3 months without achieving PASI90 and a BSA >3%. Sixty patients will be enrolled in this 16-week open-label study. Patients will be enrolled at two different sites in the US.
After enrollment, study visits will occur at monthly intervals, with patients receiving bimekizumab 320 mg via subcutaneous injection at weeks 0, 4, 8, 12 and 16. At each visit, patients will be evaluated for change in PGA (Physician's Global Assessment), PASI score, BSA and any signs or symptoms of adverse events. Laboratory screening will include tests for tuberculosis. The primary efficacy endpoint will be the percentage of patients achieving BSA < 1 by week 16.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with moderate-to-severe psoriasis | Experimental | Drug: BimekizumabIndividuals with moderate-to-severe psoriasis who have failed similar therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female participant at least 18 years of age
- Participant is able to provide written informed consent and comply with the requirements of this study protocol.
- Participant has a BSA score of >3 prior to randomization.
- Participant has previously failed treatment with an IL-17or IL-23 agent, defined as previous treatment with either drug for at least 3 months without achieving a BSA ≤3.
- Participant's last dose with most recent IL-17 or IL-23 agent was at least 28 days prior to baseline visit.
Key exclusion criteria (17 listed)
- Have predominantly pustular, erythrodermic, and/or guttate forms of psoriasis.
- Have drug induced psoriasis
- History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive tuberculin purified protein derivative (PPD) or QuantiFERON TB-Gold test (QFT) at Screening. Participant with a positive or indeterminate PPD or QFT test must be assessed for evidence of active TB versus latent TB within 12 weeks prior to Baseline, including signs and symptoms and chest x-ray. If presence of latent tuberculosis is established, then treatment must have been initiated at least for 4 weeks prior to Baseline and completed. Participant with evidence of active TB may not be enrolled.
- Participants with a history of HIV, or history of hepatitis C or B infections.
- Use of any of the following therapies within 4 weeks prior to Baseline (Visit 2): systemic non-biologic psoriasis therapies, including, but not limited to: psoralens (topical or oral) and ultraviolet A (PUVA) therapy, cyclosporine, methotrexate, azathioprine, corticosteroids, apremilast, any JAK or TYK2 Inhibitors, oral retinoids, mycophenolate mofetil, sirolimus, 1, 25 dihydroxyvitamin D analogs, and other forms of phototherapy (including UVB or self-treatment with tanning beds or therapeutic sunbathing).
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 |
|---|---|---|
| BimekizumabBimekizumab 320 mg via subcutaneous injections. Bimekizumab is a humanized immunoglobulin G1 monoclonal antibody that selectively binds to and neutralizes the biologic functions of both interleukin-17A (IL-17A) and IL-17F, which are known to increase inflammation. | Drug | Individuals with moderate-to-severe psoriasis |
Primary outcome
Body Surface Area (BSA) of < 1
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Body Surface Area (BSA) < 1 describes psoriasis affecting less than 1 percent of the body's surface. One hand covers roughly 1% of the body's surface area. Psoriasis affecting less than 3 percent BSA may be considered mild, 3 to 10 percent as moderate and more than 10 percent as severe.
4 secondary outcomes
Psoriasis and Severity Index Score (PASI) of < 1
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Physician Global Assessment (PGA) of < 1
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Psoriasis and Severity Index Score (PASI) of < 2
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
Physician Global Assessment (PGA) of < 2
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16
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 20 Apr 2026.
- Individual participant dataSharing planned: No. Results will be provided as aggregated data.
Related trials for Plaque Psoriasis
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Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
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A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
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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.
Mark Lebwohl, MD principal investigator
Ichan School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bimekizumab in people with Plaque Psoriasis, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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 17 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Body Surface Area (BSA) of < 1 (time frame: Baseline, Week 4, Week 8, Week 12, Week 16). 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 20 Apr 2026.