A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis

Launched by UCB BIOPHARMA SRL · Jul 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called bimekizumab on people with moderate to severe plaque psoriasis, a skin condition that causes red, scaly patches. The trial aims to see how this medication influences certain biological markers in the skin after 48 weeks of treatment. It is open to adults aged 18 and older who have been diagnosed with plaque psoriasis for at least six months and have a significant level of severity in their condition. Additionally, some participants with both psoriasis and active psoriatic arthritis, a type of arthritis that affects some people with psoriasis, may also be included.

Participants in the trial can expect to undergo assessments of their skin condition and may need to provide skin samples for testing. They should be willing to follow specific guidelines, such as maintaining their usual sun exposure habits and using sunscreen when necessary. It's important for potential participants to be in generally good health and meet certain criteria, like not having other serious infections or other inflammatory diseases. Overall, this study aims to gather more information about the effectiveness of bimekizumab and how it works within the body to help manage psoriasis and psoriatic arthritis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Cohort A and Cohort B
• • Study participant must be at least 18 years of age inclusive at the time of signing the Informed Consent Form (ICF)
• * Study participant must have:
• • 1. Cohort A and Cohort B: Plaque psoriasis (PSO) diagnosed for at least 6 months prior to the Screening Visit
• • 2. Cohort B only: In addition to the criteria specified above, study participant has a documented diagnosis of adult-onset psoriatic arthritis (PsA) and meets the CASPAR classification criteria for at least 6 months prior to Screening for active PsA and must have ≥1 tender joint count (TJC) out of 68 and ≥1 swollen joint count (SJC) out of 66 at Screening or up to 3 months before Screening (documented evidence)
• • Study participant must have Psoriasis Area and Severity Index (PASI) score ≥12 and body surface area (BSA) affected by PSO ≥10% and Investigator's Global Assessment (IGA) score ≥3 on a 5 point scale
• • Study participant must be a candidate for systemic PSO therapy and/or phototherapy
• • Study participant agrees not to change their usual sun exposure during the course of the study and to use ultraviolet A/ultraviolet B sunscreens if unavoidable exposure occurs
• • Study participant has body weight \<120 kg
• * A female study participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• • Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Run In Treatment Period, the Randomized Treatment Extension Period, theTreatment Extension Period, the Escape Treatment Period, and for 17 weeks after the final dose of investigational medicinal product (IMP)
• • Control Cohort
• • Study participant must be ≥18 years of age at the time of signing the informed consent
• • Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs
• • Study participant has body weight \<120 kg
• • Female study participant is eligible to participate if they are not pregnant and not breastfeeding
• Exclusion Criteria:
• • Cohort A and Cohort B
• • Study participant has a form of PSO other than plaque type (eg, pustular, erythrodermic and guttate PSO, or drug induced PSO)
• * Study participant has an active infection or history of infection(s) as follows:
• • 1. Any active systemic infection within 14 days prior to Baseline
• • 2. A serious infection, defined as requiring hospitalization or intravenous anti-infective(s) within 2 months prior to the Baseline Visit
• • 3. A history of opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause this study to be detrimental to the study participant
• • At investigator's discretion, study participant with chronic (medically controlled) viral hepatitis B or C or human immunodeficiency virus (HIV) infection, or history of hepatitis B.
• * Study participant has any of the following:
• • 1. Known active tuberculosis (TB) disease.
• • 2. History of active TB involving any organ system unless adequately treated
• • 3. High risk of acquiring TB infection
• • Study participant has a verified diagnosis of inflammatory conditions other than PSO or PsA, including but not limited to rheumatoid arthritis (RA), sarcoidosis, inflammatory bowel diseases (IBD), or systemic lupus erythematosus. Note: Study participants with a diagnosis of IBD are allowed if they have no active symptomatic disease at Screening or Baseline
• • 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
• • 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
• • Study participant has a known hypersensitivity to any components of the IMP as stated in this protocol
• • Study participant has a history of primary failure to any biologic (ie, no response within the first 12 weeks of treatment)
• • Study participant has laboratory abnormalities at Screening
• • Study participant has a current history of alcohol or drug use disorder, as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM) V, within the previous 6 months prior to Screening, as evaluated by the investigator based on medical history, and/or site interview
• • Control Cohort
• • - Study participant has any systemic disease (eg, cardiovascular, neurological, renal, liver, metabolic, gastrointestinal, hematological, coagulation disorders, immunological) considered by the investigator to be uncontrolled, unstable, or likely to progress to a clinically significant degree during the course of the study