Clinical trial NCT06506916: A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
Official title: A Phase 3b Exploratory Multicenter Open-Label Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Moderate to Severe Plaque Psoriasis
Psoriatic Arthritis
Keywords: Moderate to Severe Plaque Psoriasis
PSO
Phase 3
Bimekizumab
Biomarkers
PsA
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48
timeFrame: Week 48, compared to Baseline
Secondary outcomes:
measure: Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU)
timeFrame: From Baseline to End of SFU (up to Week 100)
measure: Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU
timeFrame: From Baseline to End of SFU (up to Week 100)
measure: TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU
timeFrame: From Baseline to End of SFU (up to Week 100)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Ps0039 50140
state: Alabama
city: Fountain Valley
country: United States
facility: Ps0039 50162
state: California
city: Santa Monica
country: United States
facility: Ps0039 50642
state: California
city: Tampa
country: United States
facility: Ps0039 50283
state: Florida
city: Ann Arbor
country: United States
facility: Ps0039 50110
state: Michigan
city: Rochester
country: United States
facility: Ps0039 50643
state: New York
city: Pittsburgh
country: United States
facility: Ps0039 50491
state: Pennsylvania
city: Berlin
country: Germany
facility: Ps0039 40515
city: Frankfurt/main
country: Germany
facility: Ps0039 40287
city: Freiburg Im Breisgau
country: Germany
facility: Ps0039 40072
city: Witten
country: Germany
facility: Ps0039 40775
city: Lodz
country: Poland
facility: Ps0039 40347
city: Lodz
country: Poland
facility: Ps0039 40625
city: Poznan
country: Poland
facility: Ps0039 40757
city: Warszawa
country: Poland
facility: Ps0039 40761
city: Wroclaw
country: Poland
facility: Ps0039 40773
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: