A study to evaluate the efficacy and safety of bimekizumab in adult study participants with active psoriatic arthritis

JRCT ID: jRCT2051240151

Registered date:07/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Psoriatic Arthritis
• Date of first enrollment: 15/11/2024
• Target sample size: 30
• Countries of recruitment: Europe and North America,Japan
• Study type: Interventional

Intervention(s)

[Experimental: Bimekizumab]
Study participants will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding during treatment period.
[Experimental: Risankizumab]
Study participants will receive assigned Risankizumab dosage regimen and placebo to maintain the blinding during treatment period.

Outcome(s)

Primary Outcome

American College of Rheumatology 50 (ACR50) at Week 16
The ACR50 response rate is based on a 50% or greater improvement of arthritis relative to Baseline.
-TJC and SJC: 2-point scale (0=absent; 1=present)
-Patient's Global Assessment of Psoriatic Arthritis (PGA-PsA): 100 VAS (0=very good, no symptoms; 100=very poor, severe symptoms)
-Physician's Global Assessment of Psoriatic Arthritis (PhGA-PsA): 100 VAS (0=very good, asymptomatic, no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities).
-Patient's Assessment of Arthritis pain (PtAAP): 100 VAS (0=no pain; 100=most severe pain).
-Health Assessment Questionnaire Disability Index score (HAQ-DI) assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability.
-High sensitivity C-reactive protein (hs-CRP) in mg/mL
[Time Frame: Week 16]

Secondary Outcome

1.Minimal Disease Activity (MDA) at Week 16
A study participant is considered as having MDA if 5 or more of the following 7 criteria are fulfilled:
-Tender joint count =<1
-Swollen joint count =<1
-PASI =<1 or BSA =<3
-PtAAP VAS =<15
-PGA-PsA VAS =<20
-HAQ-DI=<0.5
-Tender enthesial points =<1
[Time Frame: Week 16]
2.Percentage of participants reaching the composite endpoint composed of ACR50 and Psoriasis Area and Severity Index 100% (PASI100) response at Week 16 in the subgroup of study participants with PSO involving at least 3% body surface area (BSA) at Baseline
-The ACR50 response is based on a 50% or greater improvement of arthritis relative to Baseline.
-The PASI100 response is based on at least 100% improvement in the PASI score.
Body divided in to 4 areas: head, upper extremities, trunk and lower extremities.
Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of body areas and converting to a 0 to 6 scale.
Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
[Time Frame: Week 16]
3.Incidence of Participants With treatment-emergent adverse events (TEAEs)
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP.
[Time Frame: From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)]
4.Incidence of Participants With Treatment-emergent serious AEs
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
-Results in death
-Is life-threatening
-Requires in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect
-Results in permanent or significant disability/incapacity
-Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
[Time Frame: From Baseline (Day 1) to End of Safety Follow-Up (up to 42 weeks)]
5.Incidence of Participants With TEAEs leading to withdrawal from investigational medicinal product (IMP)
An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP.
[Time Frame: Frome Baseline 8Day 1] to End of Safety Follow-Up (up to 42 weeks)]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Study participants must have a documented diagnosis of adult-onset PsA classified by and that meets the CASPAR classification criteria for at least 6 months prior to Screening with active PsA (despite previous csDMARD or apremilast therapy) and must have at Baseline tender joint count (TJC) >=3 out of 68 joints and swollen joint count (SJC) >=3 out of 66 joints (dactylitis of a digit counts as 1 joint each).
2.Study participant must have at least 1 active psoriatic lesion(s) and/or a documented history of chronic plaque-type psoriasis (PSO).
3.Study participants may currently be on conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy and must have previously been treated with at least 1 csDMARD (methotrexate (MTX), leffunomide (LEF), sulfasalazine (SSZ)). Study participants must have had an inadequate response to therapy or discontinued due to intolerance. (Inadequate response is determined by the Investigator and is defined as not achieving the minimal response after 12 weeks of therapy.)
4.Study participants can either be biological disease-modifying antirheumatic drug (bDMARD)-naive or have received not more than 1 prior tumor necrosis factor alpha (TNFa) inhibitor. Study participants who have been on a TNFa inhibitor previously must not have discontinued the TNFa inhibitor due to financial or health insurance reasons and must have either:
-experienced an inadequate response to previous treatment given at an approved dose for at least 3 months, or
-been intolerant to administration (eg, had a side-effect/AE that led to discontinuation).

Exclude criteria

1. Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
2. Female study participants who are breastfeeding, pregnant, or plan to become pregnant during the study or within 17 weeks following final dose of IMP.
3. Study participant has an active infection or history of resent serious infections.
4. Study participant has a known active tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection.
5. Study participant has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, reactive arthritis, and axial spondyloarthritis.
6. Study participants with a history of anterior uveitis are allowed if they have no active symptoms at Screening or Baseline. Study participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.
7. Study participants with fibromyalgia or osteoarthritis symptoms that in the Investigator's opinion would have potential to interfere with efficacy assessments.
8. Study participant has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer.
9. Study participant has a history of chronic alcohol or drug abuse within 6 months prior to Screening.
10. Study participants taking psoriatic arthritis (PsA) medications other than MTX, SSZ, apremilast, hydroxychloroquine (HCQ), LEF, nonsteroidal anti-inflammatory drug (NSAIDs)/cyclooxygenase-2 (COX-2) inhibitors, oral corticosteroids, and analgesics as outlined in the Inclusion criteria.
11. Study participant is taking or has taken prohibited PsA or PSO medications without meeting the mandatory wash-out period relative to the Baseline Visit.
12. Study participant is taking or has taken JAK inhibitor.
13. Study participant is taking or has taken bDMARDs, including bimekizumab or risankizumab, with the exception of having received 1 prior TNFa inhibitor.
14. Study participant previously participated in another study of a medical device under investigation within the 4 weeks prior to the Screening Visit or is currently participating in another study of a medical device under investigation.

Related Information

• Primary Sponsor: Matano Mizuho
• Secondary ID(s): ID: IND128708