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

NCT06506916 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: PS00392023-506333-29-00U1111-1299-2563
• Study Type: interventional
• Target: 90
• Locations: 3 countries
• Sites: 16

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).

Conditions

Moderate to Severe Plaque Psoriasis; Psoriatic Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in composite gene expression score using reverse transcription-polymerase chain reaction (RT-PCR) in lesional skin at Week 48

  Composite gene expression score using RT-PCR in lesional skin at Baseline and Week 48 using preselected genes based on bimekizumab mechanism of action and PSO disease biology pathways.

  Week 48, compared to Baseline

Secondary Outcomes (3)

• Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU)

  From Baseline to End of SFU (up to Week 100)

• Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU

  From Baseline to End of SFU (up to Week 100)

• TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU

  From Baseline to End of SFU (up to Week 100)

Study Arms (3)

Cohort A

EXPERIMENTAL

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.

Drug: bimekizumab

Cohort B

EXPERIMENTAL

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.

Drug: bimekizumab

Control Cohort

NO INTERVENTION

Healthy participants, who will not receive IMP during the study.

Interventions

bimekizumab DRUG

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

Also known as: BKZ

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Cohort A and Cohort B: Plaque psoriasis (PSO) diagnosed for at least 6 months prior to the Screening Visit
• 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

You may not qualify if:

• 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:
• Any active systemic infection within 14 days prior to Baseline
• A serious infection, defined as requiring hospitalization or intravenous anti-infective(s) within 2 months prior to the Baseline Visit
• 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:
• Known active tuberculosis (TB) disease.
• History of active TB involving any organ system unless adequately treated
• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (16)

Ps0039 50140

Birmingham, Alabama, 35233, United States

RECRUITING

Ps0039 50162

Fountain Valley, California, 92708, United States

RECRUITING

Ps0039 50642

Santa Monica, California, 90404, United States

WITHDRAWN

Ps0039 50283

Tampa, Florida, 33613, United States

RECRUITING

Ps0039 50110

Ann Arbor, Michigan, 48109, United States

RECRUITING

Ps0039 50643

Rochester, New York, 14623, United States

RECRUITING

Ps0039 50491

Pittsburgh, Pennsylvania, 15213-2536, United States

RECRUITING

Ps0039 40515

Berlin, Germany

ACTIVE NOT RECRUITING

Ps0039 40287

Frankfurt am Main, Germany

ACTIVE NOT RECRUITING

Ps0039 40072

Freiburg im Breisgau, Germany

ACTIVE NOT RECRUITING

Ps0039 40775

Witten, Germany

WITHDRAWN

Ps0039 40347

Lodz, Poland

ACTIVE NOT RECRUITING

Ps0039 40757

Poznan, Poland

ACTIVE NOT RECRUITING

Ps0039 40625

Warsaw, Poland

ACTIVE NOT RECRUITING

Ps0039 40761

Warsaw, Poland

ACTIVE NOT RECRUITING

Ps0039 40773

Wroclaw, Poland

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

bimekizumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Central Study Contacts

UCB Cares

CONTACT

1-844-599-2273 (USA); ucbcares@ucb.com

UCB Cares

CONTACT

001 844 599 2273; UCBCares@ucb.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 18, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): March 14, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

DE (4); US (7); PL (5)