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Psoriasis VulgarisPhase 4NCT05499416

Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis

A Phase 4 study testing Bimekizumab in people with Psoriasis Vulgaris and Active Psoriatic Arthritis, run by Innovaderm Research Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open-label study to evaluate the effects of bimekizumab in patients with psoriasis vulgaris and who also have active psoriatic arthritis (PsA). Read more about this study

Who is it for?
Ages 18 years and older
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
0 participants
Where
No sites listed yet
Study dates
Jan 2023to Apr 2024
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 patient 18 years of age or older at the time of consent.
  • Patient with a history of psoriasis vulgaris and PsA (as determined by the investigator) for ≥ 6 months prior to the screening visit.
  • Patient with moderate-to-severe psoriasis vulgaris before initiating treatment with an anti-IL23 agent.
  • Patient with an inadequate skin response to at least 12 weeks treatment with an anti-IL23 agent for the treatment of psoriasis vulgaris as defined by a PGA ≥ 2 and plaque psoriasis covering ≥ 1% of total BSA (excluding palms and soles) at the screening and Day 1 visits.
  • Patient with active PsA as defined by ≥ 1 joint that is tender (TJC68) and/or swollen (SJC66) at Day 1.

Who cannot join

  • Female who is breastfeeding, pregnant, or who is planning to become pregnant during the study or within 4 months after the last study product administration.
  • Patient with evidence of erythrodermic, pustular, predominantly guttate psoriasis, or drug-induced psoriasis.
  • Patient with any known clinically significant medical condition or presence of a skin or rheumatologic disease that would, in the opinion of the investigator, put the patient at undue risk or interfere with the interpretation of study results.
  • Patient who plans to receive a live or live-attenuated vaccine during the study and up to 4 weeks or 5 half-lives (of the study product), whichever is longer, after the last study product administration.
  • Patient with an active infection (except common cold) that would place them at increased risk, a recent serious infection, or a history of opportunistic, recurrent, or chronic infections.
  • Patient with a diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis).
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  • Patient with known or suspected hypersensitivity to bimekizumab or any component of the investigational product, including any nonmedicinal ingredient, or component of the container.
  • Patient who has received any marketed or investigational biological agent, except anti-IL23 agents, within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1.
  • Patient who has received treatment with bimekizumab prior to Day 1.

About this study

Official title: Effect of Bimekizumab in Patients With Psoriasis Vulgaris and Active Psoriatic Arthritis Who Have an Inadequate Skin Response to Anti-IL23 Therapy

This is an open-label study to evaluate the effects of bimekizumab in patients with psoriasis vulgaris and who also have active psoriatic arthritis (PsA).

Read the detailed description

This study is being conducted to evaluate the effects of bimekizumab administered subcutaneously (SC) to patients with psoriasis vulgaris and who also have active PsA who have an inadequate skin response to anti-interleukin (IL)23 therapy. Approximately 20 adult subjects with psoriasis vulgaris and active PsA who have an inadequate skin response to anti-IL23 will receive bimekizumab 320 mg solution administered SC every 4 weeks for 16 weeks.

Being tested
Bimekizumab
Keywords
plaque psoriasis, systemic therapy, psoriasis vulgaris, arthritic psoriasis, bimekizumab
Medical subject headings
Arthritis, Psoriatic

What participants receive

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

  • BimekizumabDrug

    Also called BIMZELX®

    Self-administration of two (2-160 mg/mL [1 mL]) pre-filled syringes or autoinjectors at baseline (Day1) and at Weeks 4, 8,12, and 16

Study groups in NCT05499416
Study groupRoleWhat they receive
Bimekizumab 320 mg SC injectionsExperimentalBimekizumab 320 mg solution administered via SC injections every 4 weeks for 16 weeks.
Receives: Drug: Bimekizumab

What is being measured

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

  1. Physician Global Assessment (PGA) x Body Surface Area (BSA)

    The product of physician's global assessment and body surface area (PGA×BSA) is a measure of psoriasis severity (0-400), with higher scores indicating more severe disease.

    Measured: Week 24

  2. Proportion of patients achieving MDA

    A patient will be considered to have achieved MDA when meeting 5/7 of the following criteria: tender joints count ≤ 1; swollen joints count ≤ 1; Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%; patient pain visual analog scale (VAS) ≤ 15 mm; patient's global assessment of arthritis visual analog scale (PtGA VAS) ≤ 20 mm; Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5; tender entheseal points ≤ 1.

    Measured: Week 24

Secondary outcomes (15)

  1. Physician Global Assessment (PGA)

    The PGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity, with higher scores indicating more severe disease.

    Measured: Weeks 12 and 24

  2. Body Surface Area (BSA)

    The overall BSA affected by psoriasis vulgaris will be evaluated (from 0% to 100%).

    Measured: Weeks 12 and 24

  3. Psoriasis Area and Severity Index (PASI)

    The PASI is a composite score that considers the degree of erythema, induration/infiltration, and desquamation (each scored from 0 to 4 separately) for each of 4 body regions.

    Measured: Weeks 12 and 24

  4. American College of Rheumatology (ACR)

    The ACR is a composite including the number of tender and number of swollen joints, patient's global assessment of arthritis visual analog scale (PtGA VAS), physician global assessment visual analog scale (MDGA VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient pain visual analog scale (VAS), and C-reactive protein (CRP) levels. The proportion of patients achieving ACR20, ACR50, and ACR70 will be calculated.

    Measured: Week 24

  5. Tender joints count (TJC)

    The tenderness of 68 joints (TJC68) will be assessed and the counts recorded.

    Measured: Week 24

  6. Swollen joints count (SJC)

    The level of swelling at 66 joints (SJC66) will be assessed and the counts recorded. The swollen joints count can range between 0 and 66 and represents the sum of the total number of swollen joints.

    Measured: Week 24

  7. Physician's Global Assessment of Arthritis Visual Analogue Scale (MDGA VAS)

    The physician's global assessment of disease activity will be measured using 100-mm VAS scale with anchor statements on the left (none) and on the right (extremely active).

    Measured: Week 24

  8. Patient's Assessment of Arthritis Pain Visual Analogue Scale (patient pain VAS)

    The patient's assessment of pain will be measured using 100-mm VAS scale with anchor statements on the left (no pain) and on the right.

    Measured: Week 24

  9. Patient's Global Assessment of Arthritis Visual Analogue Scale (PtGA VAS)

    The patient's global assessment of disease activity will be measured using 100-mm VAS scale with anchor statements on the left (very well) and on the right (very poorly).

    Measured: Week 24

  10. Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC)

    The SPARCC Enthesitis Index is a composite score that quantifies the extent of tenderness at 16 sites on a dichotomous basis.

    Measured: Week 24

  11. Leeds Enthesitis Index (LEI)

    The LEI is an enthesitis index that involves evaluation of tenderness at 6 examination points/sites bilaterally. The LEI score can range between 0 and 6, with higher scores indicating more enthesis sites.

    Measured: Week 24

  12. Dactylitis Count

    Dactylitis is characterized by diffuse swelling of a finger and/or toe.

    Measured: Week 24

  13. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    The BASDAI is a self-administered instrument that measures severity of fatigue/tiredness, spinal and peripheral joint pain, localized tenderness, and morning stiffness. The BASDAI score can range between 0 and 10, with higher scores indicating worse disease control.

    Measured: Weeks 12 and 24

  14. Health Assessment Questionnaire-Disability Index (HAQ-DI)

    The HAQ-DI is a patient questionnaire that evaluates the degree of disability and pain index over the past week. The HAQ-DI score can range between 0 and 3, with higher scores indicating more disability and pain.

    Measured: Weeks 12 and 24

  15. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

    The FACIT-F is a 13-item measure, which be used to assess fatigue and its impact on daily activities and function in the past 7 days. The FACIT-F score can range between 0 and 52, with higher scores indicating less fatigue.

    Measured: Weeks 12 and 24

Timeline

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

  1. First posted12 Aug 2022
  2. Study startJan 2023 (estimated)
  3. Primary completionSep 2023 (estimated)
  4. Study completionApr 2024 (estimated)

Why it stopped: Sponsor decision.

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05499416
Sponsor's protocol ID
INNO-5031
Status last verified
Mar 2023
First submitted
3 Aug 2022
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bimekizumab in people with Psoriasis Vulgaris and Active Psoriatic Arthritis, run by Innovaderm Research Inc..

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 5 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: withdrawn, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Physician Global Assessment (PGA) x Body Surface Area (BSA) (time frame: Week 24). 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 NCT05499416.

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 15 Mar 2023.

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