A study to learn how bimekizumab works in people with moderate to severe plaque psoriasis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UCB Biopharma

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

1 Oct 2024 → ongoing

Decision date (initial)

2024-08-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-506333-29-00

WHO UTN

U1111-1299-2563

ClinicalTrials.gov

NCT06506916

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Therapy, Pharmacodynamic, Pharmacogenetic, Others, Efficacy, Safety

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)

Secondary objectives 1

1. To assess the safety and tolerability of bimekizumab in study participants with moderate to severe plaque PSO and moderate to severe plaque PSO with concomitant active PsA from Baseline to the end of the Safety Follow-Up (SFU) Period

Conditions and MedDRA coding

Moderate to Severe Plaque Psoriasis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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: 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) - 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, the Treatment Extension Period, the Escape Treatment Period, and for 17 weeks after the final dose of investigational medicinal product (IMP)

Exclusion criteria 1

1. 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: 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 - 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: 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 - 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 1

1. 1. Treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-Up (SFU) 2. Treatment-emergent serious adverse event (TESAEs) from Baseline to the end of the SFU 3. TEAEs leading to permanent discontinuation of IMP from Baseline to the end of the SFU

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UCB Biopharma

Sponsor organisation

UCB Biopharma

Address

Researchdreef 60

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Public contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Third parties 11

Locations

2 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 41 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications