Moderate to Severe Plaque Psoriasis, Psoriatic Arthritis
Conditions
Keywords
Moderate to Severe Plaque Psoriasis, PSO, Phase 3, Bimekizumab, Biomarkers, PsA
Brief summary
The purpose of this study is to evaluate the effect of bimekizumab on gene expression biomarkers at Week 48 in a subset of study participants with moderate to severe plaque psoriasis (PSO) and moderate to severe plaque PSO with concomitant active psoriatic arthritis (PsA) who have provided skin biopsies for reverse transcription-polymerase chain reaction (RT-PCR).
Interventions
DRUGbimekizumab
Study participants receive bimekizumab (BKZ) administered subcutaneously at pre-specified timepoints during study.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48 | Week 48, compared to Baseline | Composite gene expression score using RT-PCR in lesional skin at Baseline and Week 48 using preselected genes based on bimekizumab mechanism of action and PSO disease biology pathways. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU) | From Baseline to End of SFU (up to Week 100) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. TEAEs are defined as those AEs that have a start date on or following the first dose of IMP through SFU (at least 12 weeks after final IMP dose and not before 4 weeks after the last skin biopsy). |
| Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU | From Baseline to End of SFU (up to Week 100) | A serious adverse event (SAE) must meet 1 or more of the following criteria: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly/birth defect * Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious. TESAEs are defined as those SAEs that have a start date on or following the first dose of IMP through SFU (at least 12 weeks after final IMP dose and not before 4 weeks after the last skin biopsy). |
| TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU | From Baseline to End of SFU (up to Week 100) | This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. |
Countries
Germany, Poland, United States
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273
Outcome results
None listed