BIMEKIZUMAB for Moderate to severe plaque psoriasis|Psoriatic arthritis

Inclusion criteria

• {"criterion_text":"- Cohort A and Cohort B"}
• {"criterion_text":"- Study participant must be at least 18 years of age inclusive at the time of signing the Informed Consent Form (ICF)"}
• {"criterion_text":"- Study participant must have: a) Cohort A and Cohort B: Plaque psoriasis (PSO) diagnosed for at least 6 months prior to the Screening Visit b) 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)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Study participant must be a candidate for systemic PSO therapy and/or phototherapy"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Study participant has body weight <120 kg"}
• {"criterion_text":"- 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, the Treatment Extension Period, the Escape Treatment Period, and for 17 weeks after the final dose of investigational medicinal product (IMP)"}

Exclusion criteria

• {"criterion_text":"- Cohort A and Cohort B"}
• {"criterion_text":"- Study participant has a form of PSO other than plaque type (eg, pustular, erythrodermic and guttate PSO, or drug induced PSO)"}
• {"criterion_text":"- Study participant has an active infection or history of infection(s) as follows: a) Any active systemic infection within 14 days prior to Baseline b) A serious infection, defined as requiring hospitalization or intravenous anti-infective(s) within 2 months prior to the Baseline Visit c) 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"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Study participant has any of the following: a) Known active tuberculosis (TB) disease. b) History of active TB involving any organ system unless adequately treated c) High risk of acquiring TB infection"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Study participant has a known hypersensitivity to any components of the IMP as stated in this protocol"}
• {"criterion_text":"- Study participant has a history of primary failure to any biologic (ie, no response within the first 12 weeks of treatment)"}
• {"criterion_text":"- Study participant has laboratory abnormalities at Screening"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Baseline and Week 48 using preselected genes based on Bimekizumab mechanism of action and PSO disease biology pathways","definition_or_measurement_approach":"Measured by RT-PCR in lesional skin at Baseline and Week 48 using preselected genes based on bimekizumab mechanism of action and psoriasis (PSO) disease biology pathways."}

Secondary endpoints

• {"endpoint_text":"- 1. Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU)","definition_or_measurement_approach":"Assessment and recording of TEAEs occurring from Baseline through the end of the Safety Follow-Up period."}
• {"endpoint_text":"- 2. Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU","definition_or_measurement_approach":"Assessment and recording of treatment-emergent serious adverse events from Baseline through the end of the Safety Follow-Up period."}
• {"endpoint_text":"- 3. TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU","definition_or_measurement_approach":"Recording of any treatment-emergent adverse events that result in permanent discontinuation of the investigational medicinal product from Baseline through the end of the Safety Follow-Up period."}

Methods

• Country-specific recruitment materials/documents listed on CTIS including posters (e.g., ps0039-pl-poster-pl-PL-public for Poland, ps0039-de-poster-de-DE-public for Germany)
• Email outreach/HTML email (e.g., ps0039-de-html-email-de-DE-public for Germany)
• Social media materials (e.g., ps0039-pl-recr-smam-pl-PL-public and ps0039-de-recr-sm-de-DE-public indicating social media campaigns)
• Site-based recruitment materials and procedures (recruitment procedure documents: ps0039-pl-recr-proc-en-pl-PL-public, ps0039-de-icf-recr-proc-en-public)
• Site information brochures and patient-facing leaflets (e.g., sibd/sibp documents listed per country)

Germany

Earliest CTIS Part Ii Submission Date

01-07-2024

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

660

Number Of Sites

3

Number Of Participants

16

Poland

Earliest CTIS Part Ii Submission Date

22-07-2024

Latest Decision Or Authorization Date

07-03-2026

Processing Time Days

593

Number Of Sites

5

Number Of Participants

30

Primary sponsor

Full Name

UCB Biopharma

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Icon Laboratory Services Inc.

Responsibilities

code: 4

Name

PPD Development LP

Responsibilities

code: 4

Name

Medidata Solutions Inc.

Responsibilities

code: 6

Name

4G Clinical B.V.

Responsibilities

code: 3

Third parties

• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Scales & Linguistic validation services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"code: 11","organisation_type":"Patient organisation/association"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Provider of an online SaaS Portal that supports stakeholders involved in the clinical trial (patients/caregivers, study team/CRO staff, and clinical site staff).","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"code: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"ePROs/eClinROs/eConsent","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Sweden","full_name":"TATAA Biocenter AB","duties_or_roles":"RT-qPCR and RNA Sequencing","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Quantificare SA","duties_or_roles":"Photography Vendor","organisation_type":"Industry"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 6","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}