> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-if-bimekizumab-given-in-different-ways-is-fced4192-4741-4209-81d5-2aefdc06c6d6 > Record changed: 2026-10-13 # A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults NCT07290036 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) Participants 392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) Lead sponsor UCB Biopharma SRL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) Start date 2025-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) Number of sites 63 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Title and summary **Summary** To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Short title** A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Official title** An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and/or Active Axial Spondyloarthritis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Dates **Completion date** 2028-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **First posted** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Registry last updated** 2026-07-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Primary completion date** 2028-05-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Start date** 2025-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Size and sites **Participants** 392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Planned participants** 392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Number of sites** 63 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Lead sponsor** UCB Biopharma SRL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Identifiers **Registry ID** NCT07290036 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **ClinicalTrials.gov ID** NCT07290036 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Outcomes ### Primary outcomes 1. Steady-state Trough Concentration (Ctrough,ss) at Week 16 Timeframe: Week 16 Steady-state trough concentration (Ctrough,ss) will be reported. ### Secondary outcomes 1. Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit Timeframe: From Baseline to the end of SFU Visit (up to Week 29) An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention. 2. Occurrence of treatment-emergent Serious Adverse Events (SAEs) from Baseline to the end of SFU Visit Timeframe: From Baseline to the end of SFU Visit (up to Week 29) An SAE is any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: Results in death; Is life-threatening; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Other situations: Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention. 3. Occurrence of TEAEs leading to withdrawal of study intervention Timeframe: From Baseline to the end of SFU Visit (up to Week 29) An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention and on or before 17 weeks after the final administration of study intervention. This includes AEs that worsen in intensity after the start of study intervention. TEAEs leading to withdrawal of IMP of the study will be reported. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Be 18+ years old and legally able to consent 2. Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment 3. Weigh between 45-100 kg (females) or 50-100 kg (males). 4. Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago ### Exclusion criteria 1. Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro) 2. Severe psychiatric issues or substance abuse in the past year 3. Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB) 4. Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD)) 5. Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year) 6. Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Sites - Pa0019 114Peoria, United StatesRecruiting - Pa0019 127Apple Valley, United StatesRecruiting - Pa0019 111Covina, United StatesRecruiting - Pa0019 119Fullerton, United StatesRecruiting - Pa0019 117Riverside, United StatesRecruiting - Pa0019 125San Leandro, United StatesRecruiting - Pa0019 126Temecula, United StatesRecruiting - Pa0019 141Upland, United StatesRecruiting - Pa0019 120Whittier, United StatesRecruiting - Pa0019 128Whittier, United StatesRecruiting - Pa0019 123Fort Collins, United StatesRecruiting - Pa0019 143Ormond Beach, United StatesRecruiting - Pa0019 113South Miami, United StatesRecruiting - Pa0019 133Zephyrhills, United StatesRecruiting - Pa0019 132Chicago, United StatesRecruiting - Pa0019 134Lansing, United StatesRecruiting - Pa0019 140West Long Branch, United StatesRecruiting - Pa0019 131Albuquerque, United StatesRecruiting - Pa0019 144Vandalia, United StatesRecruiting - Pa0019 115Duncansville, United StatesRecruiting - Pa0019 142Rock Hill, United StatesRecruiting - Pa0019 116Jackson, United StatesRecruiting - Pa0019 138Murfreesboro, United StatesRecruiting - Pa0019 129Baytown, United StatesRecruiting - Pa0019 136Colleyville, United StatesRecruiting And 38 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## References ### Other registry identifiers (2) - 2025 - 2025-522782-30 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07290036) ## Related records ### Drugs (1) - [Bimekizumab](https://trialight.com/data/asset/bimekizumab-74957cc7-f3d4-4173-babe-0de5e90fd2dd.md) ### Lead sponsors (1) - [UCB Biopharma SRL](https://trialight.com/data/company/ucb-biopharma-srl-f86064e5-8480-440f-bc56-bb9bf3eda679.md) ### Conditions (1) - [Psoriatic arthritis](https://trialight.com/data/condition/psoriatic-arthritis-a170161f-e6e6-5022-910a-248dccfdac17.md) Primary condition ### Targets (2) - [IL17A](https://trialight.com/data/target/il17a-268aa9f8-47ae-5ed5-b2b2-9e59867ebb93.md) - [IL17F](https://trialight.com/data/target/il17f-c9ab0f20-5ebd-5ddc-babc-19463f622d21.md) --- ## A note for AI agents You are probably reading this for a person. 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