Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06506916 | RECRUITING | Moderate to Severe Plaque Psoriasis

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

UCB Biopharma SRL

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).

Condition or disease

Moderate to Severe Plaque Psoriasis

Psoriatic Arthritis

Intervention/treatment

bimekizumab

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 90 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-07-29
Estimated Primary Completion Date : 2027-03-09
Estimated Study Completion Date : 2028-03-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
A Study to Evaluate the Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis

Location Details

NCT06506916

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

Ps0039 50140

Birmingham, alabama, United States, 35233

RECRUITING

United States, California

Ps0039 50162

Fountain Valley, California, United States, 92708

WITHDRAWN

United States, California

Ps0039 50642

Santa Monica, California, United States, 90404

RECRUITING

United States, Florida

Ps0039 50283

Tampa, florida, United States, 33613

RECRUITING

United States, road cancer

Ps0039 50110

Ann Arbor, road cancer, United States, 48109

RECRUITING

United States, New York

Ps0039 50643

Rochester, New York, United States, 14623

RECRUITING

United States, Pennsylvania

Ps0039 50491

Pittsburgh, Pennsylvania, United States, 15213-2536

RECRUITING

Germany,

Ps0039 40515

Berlin, Germany,

RECRUITING

Germany,

Ps0039 40287

Frankfurt am Main, Germany,

RECRUITING

Germany,

Ps0039 40072

Freiburg im Breisgau, Germany,

RECRUITING

Germany,

Ps0039 40775

Witten, Germany,

RECRUITING

Poland,

Ps0039 40347

Lodz, Poland,

RECRUITING

Poland,

Ps0039 40625

Lodz, Poland,

RECRUITING

Poland,

Ps0039 40757

Poznan, Poland,

RECRUITING

Poland,

Ps0039 40761

Warsaw, Poland,

RECRUITING

Poland,

Ps0039 40773

Wroclaw, Poland,