RECRUITING

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

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Conditions

Moderate to Severe Plaque PsoriasisPsoriatic ArthritisPSOPhase 3BimekizumabBiomarkersPsA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-07-29
Study Completion:2028-03-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06506916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Study participant must be at least 18 years of age inclusive at the time of signing the Informed Consent Form (ICF)
  2. * Study participant must have:
  3. 1. Cohort A and Cohort B: Plaque psoriasis (PSO) diagnosed for at least 6 months prior to the Screening Visit
  4. 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)
  5. * 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
  6. * Study participant must be a candidate for systemic PSO therapy and/or phototherapy
  7. * 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
  8. * Study participant has body weight \<120 kg
  9. * A female study participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
  10. * Study participant must be ≥18 years of age at the time of signing the informed consent
  11. * Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs
  12. * Study participant has body weight \<120 kg
  13. * Female study participant is eligible to participate if they are not pregnant and not breastfeeding
  1. * Study participant has a form of PSO other than plaque type (eg, pustular, erythrodermic and guttate PSO, or drug induced PSO)
  2. * Study participant has an active infection or history of infection(s) as follows:
  3. 1. Any active systemic infection within 14 days prior to Baseline
  4. 2. A serious infection, defined as requiring hospitalization or intravenous anti-infective(s) within 2 months prior to the Baseline Visit
  5. 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
  6. * 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.
  7. * Study participant has any of the following:
  8. 1. Known active tuberculosis (TB) disease.
  9. 2. History of active TB involving any organ system unless adequately treated
  10. 3. High risk of acquiring TB infection
  11. * 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
  12. * 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
  13. * 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
  14. * Study participant has a known hypersensitivity to any components of the IMP as stated in this protocol
  15. * Study participant has a history of primary failure to any biologic (ie, no response within the first 12 weeks of treatment)
  16. * Study participant has laboratory abnormalities at Screening
  17. * 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

Contacts and Locations

Study Contact

UCB Cares
CONTACT
1-844-599-2273 (USA)
ucbcares@ucb.com
UCB Cares
CONTACT
001 844 599 2273
UCBCares@ucb.com

Principal Investigator

UCB Cares
STUDY_DIRECTOR
001 844 599 2273

Study Locations (Sites)

Ps0039 50140
Birmingham, Alabama, 35233
United States
Ps0039 50162
Fountain Valley, California, 92708
United States
Ps0039 50642
Santa Monica, California, 90404
United States
Ps0039 50283
Tampa, Florida, 33613
United States
Ps0039 50110
Ann Arbor, Michigan, 48109
United States
Ps0039 50643
Rochester, New York, 14623
United States
Ps0039 50491
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

  • UCB Cares, STUDY_DIRECTOR, 001 844 599 2273

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-29
Study Completion Date2028-03-14

Study Record Updates

Study Start Date2024-07-29
Study Completion Date2028-03-14

Terms related to this study

Keywords Provided by Researchers

  • Moderate to Severe Plaque Psoriasis
  • PSO
  • Phase 3
  • Bimekizumab
  • Biomarkers
  • PsA

Additional Relevant MeSH Terms

  • Moderate to Severe Plaque Psoriasis
  • Psoriatic Arthritis