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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
UCB Biopharma SRL
Study ID
NCT06506916
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • bimekizumab — DRUG
    Study participants receive bimekizumab (BKZ) administered subcutaneously at pre-specified timepoints during study.

Study Details

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).

Key Dates

Start date
Jul 29, 2024
Status verified
May 2026
Primary completion
Mar 9, 2027
Completion
Mar 14, 2028

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Study participants with moderate to severe plaque PSO without concomitant active PsA (Cohort A) receive bimekizumab dosage regimen 1 from Baseline up to Week 16 and bimekizumab regimen 2 from Week 16 up to Week 48. Study participants, fulfilling randomization criteria receive bimekizumab dosage regimen 2 or 3 from Week 48 to Week 96. Study participants who do not meet the criteria for randomization receive bimekizumab dosage regimen 2 to Week 96.
  • Experimental: Cohort B
    Study participants with moderate to severe plaque PSO with concomitant active PsA (Cohort B) receive bimekizumab dosage regimen 1 from Baseline up to Week 16 and bimekizumab regimen 2 from Week 16 up to Week 48. Study participants, fulfilling randomization criteria receive bimekizumab dosage regimen 2 or 3 from Week 48 to Week 96. Study participants who do not meet the criteria for randomization receive bimekizumab dosage regimen 2 to Week 96.
  • No Intervention: Control Cohort
    Healthy participants, who will not receive IMP during the study.

Primary Outcome Measure

Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48 [ Time Frame: Week 48, compared to Baseline ]

Locations (6)

FacilityCityStateZIPSite coordinators
Ps0039 50140BirminghamAlabama35233-
Ps0039 50162Fountain ValleyCalifornia92708-
Ps0039 50283TampaFlorida33613-
Ps0039 50110Ann ArborMichigan48109-
Ps0039 50643RochesterNew York14623-
Ps0039 50491PittsburghPennsylvania15213-2536-

Find similar trials in Birmingham, AL

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Ps0039 50140· Birmingham, ALPs0039 50162· Fountain Valley, CAPs0039 50283· Tampa, FLPs0039 50110· Ann Arbor, MIPs0039 50643· Rochester, NYPs0039 50491· Pittsburgh, PA

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