Psoriatic ArthritisPhase 1NCT07290036
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
A Phase 1 study testing Bimekizumab regimen 1 iv, Bimekizumab regimen 2 iv and Bimekizumab regimen 3 sc in people with Psoriatic Arthritis and Axial Spondyloarthritis, run by UCB Biopharma SRL at 63 sites in 6 countries.
Trial summary
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis, Axial Spondyloarthritis
- What is being tested?
- Bimekizumab regimen 1 iv, Bimekizumab regimen 2 iv and Bimekizumab regimen 3 sc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 63 sitesin 6 countries
- Study dates
- 10 Dec 2025to 14 Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18+ years old and legally able to consent
- Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment
- Weigh between 45-100 kg (females) or 50-100 kg (males).
- Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago
Who cannot join
- Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)
- Severe psychiatric issues or substance abuse in the past year
- Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
- Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))
- Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)
- Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)
Trial locations and contacts
63 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
UCB Cares contact
63 sites in 6 countries
United States30 sites, 30 recruiting
- Recruiting
Pa0019 131
Albuquerque, New Mexico, 87102
- Recruiting
Pa0019 127
Apple Valley, California, 92307
- Recruiting
Pa0019 129
Baytown, Texas, 77521
- Recruiting
Pa0019 130
Beckley, West Virginia, 25801
- Recruiting
Pa0019 121
Bellevue, Washington, 98004
- Recruiting
Pa0019 132
Chicago, Illinois, 60661
- Recruiting
Pa0019 136
Colleyville, Texas, 76034
- Recruiting
Pa0019 111
Covina, California, 91722
- Recruiting
Pa0019 115
Duncansville, Pennsylvania, 16635
- Recruiting
Pa0019 123
Fort Collins, Colorado, 80528
- Recruiting
Pa0019 119
Fullerton, California, 92835
- Recruiting
Pa0019 116
Jackson, Tennessee, 38305
- Recruiting
Pa0019 134
Lansing, Michigan, 48911
- Recruiting
Pa0019 135
Mesquite, Texas, 75150
- Recruiting
Pa0019 138
Murfreesboro, Tennessee, 37128
- Recruiting
Pa0019 143
Ormond Beach, Florida, 32174
- Recruiting
Pa0019 114
Peoria, Arizona, 85381-5025
- Recruiting
Pa0019 124
Plano, Texas, 75075
- Recruiting
Pa0019 117
Riverside, California, 92518
- Recruiting
Pa0019 142
Rock Hill, South Carolina, 29732
- Recruiting
Pa0019 125
San Leandro, California, 94578
- Recruiting
Pa0019 113
South Miami, Florida, 33155
- Recruiting
Pa0019 145
Spokane, Washington, 99216
- Recruiting
Pa0019 126
Temecula, California, 92592
- Recruiting
Pa0019 141
Upland, California, 91786
- Recruiting
Pa0019 144
Vandalia, Ohio, 45377
- Recruiting
Pa0019 140
West Long Branch, New Jersey, 07764-1503
- Recruiting
Pa0019 120
Whittier, California, 90602
- Recruiting
Pa0019 128
Whittier, California, 90602
- Recruiting
Pa0019 133
Zephyrhills, Florida, 33542
Poland18 sites, 18 recruiting
- Recruiting
Pa0019 407
Bialystok
- Recruiting
Pa0019 418
Bialystok
- Recruiting
Pa0019 404
Bytom
- Recruiting
Pa0019 401
Elblag
- Recruiting
Pa0019 412
Krakow
- Recruiting
Pa0019 402
Lodz
- Recruiting
Pa0019 410
Lublin
- Recruiting
Pa0019 413
Nowa Sól
- Recruiting
Pa0019 417
Olsztyn
- Recruiting
Pa0019 415
Płońsk
- Recruiting
Pa0019 406
Poznan
- Recruiting
Pa0019 408
Poznan
- Recruiting
Pa0019 411
Poznan
- Recruiting
Pa0019 416
Torun
- Recruiting
Pa0019 405
Warsaw
- Recruiting
Pa0019 409
Warsaw
- Recruiting
Pa0019 414
Warsaw
- Recruiting
Pa0019 420
Wroclaw
Bulgaria5 sites, 5 recruiting
- Recruiting
Pa0019 204
Lovech
- Recruiting
Pa0019 205
Pleven
- Recruiting
Pa0019 201
Plovdiv
- Recruiting
Pa0019 202
Plovdiv
- Recruiting
Pa0019 203
Plovdiv
Czechia4 sites, 4 recruiting
- Recruiting
Pa0019 705
Brno
- Recruiting
Pa0019 703
Hlučín
- Recruiting
Pa0019 704
Ostrava
- Recruiting
Pa0019 702
Uherské Hradiště
Germany4 sites, 4 recruiting
- Recruiting
Pa0019 305
Berlin
- Recruiting
Pa0019 301
Hamburg
- Recruiting
Pa0019 302
Ratingen
- Recruiting
Pa0019 306
Wetzlar
Slovakia2 sites, 2 recruiting
- Recruiting
Pa0019 601
Košice
- Recruiting
Pa0019 603
Piešťany
About this study
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
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
- Conditions
- Psoriatic Arthritis, Axial Spondyloarthritis
- Being tested
- Bimekizumab regimen 1 iv, Bimekizumab regimen 2 iv, Bimekizumab regimen 3 sc
- Keywords
- Bimekizumab, BKZ, Phase 1B
- Medical subject headings
- Arthritis, Psoriatic, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bimekizumab regimen 1 ivDrug
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Bimekizumab regimen 2 ivDrug
Participants will receive bimekizumab (BKZ) at pre-specified time points.
Bimekizumab regimen 3 scDrug
Participants will receive bimekizumab (BKZ) at pre-specified time points.
| Study group | Role | What they receive |
|---|---|---|
| Bimekizumab arm 1 | Experimental | Subjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period. Receives: Drug: Bimekizumab regimen 1 iv; Drug: Bimekizumab regimen 2 iv |
| Bimekizumab arm 2 | Experimental | Subjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period. Receives: Drug: Bimekizumab regimen 3 sc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state Trough Concentration (Ctrough,ss) at Week 16
Steady-state trough concentration (Ctrough,ss) will be reported.
Measured: Week 16
Secondary outcomes (3)
Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit
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.
Measured: From Baseline to the end of SFU Visit (up to Week 29)
Occurrence of treatment-emergent Serious Adverse Events (SAEs) from Baseline to the end of SFU Visit
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.
Measured: From Baseline to the end of SFU Visit (up to Week 29)
Occurrence of TEAEs leading to withdrawal of study intervention
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.
Measured: From Baseline to the end of SFU Visit (up to Week 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start10 Dec 2025
- Primary completion18 May 2028 (estimated)
- Study completion14 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 22733 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290036
- Sponsor's protocol ID
- PA0019
- Other IDs
- 2025-522782-30, 2025
- Status last verified
- Jul 2026
- First submitted
- 4 Dec 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The sponsor does not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07290036
- Acronym / sponsor ID
- PA0019
- Conditions
- Psoriatic Arthritis, Axial Spondyloarthritis
- Keywords
- Bimekizumab, BKZ, Phase 1B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 18 May 2028 (estimated)
- Study completion
- 14 Sep 2028 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bimekizumab arm 1 | Experimental | Drug: Bimekizumab regimen 1 iv, Drug: Bimekizumab regimen 2 ivSubjects participating in the study will receive assigned bimekizumab dosing regimen 1 or 2 during the PK Lead-In Phase and dosing regimen 1 or 2 during Treatment Period. |
| Bimekizumab arm 2 | Experimental | Drug: Bimekizumab regimen 3 scSubjects participating in the study will receive assigned bimekizumab dosing regimen 3 during the PK Lead-In Phase and dosing regimen 3 during Treatment Period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18+ years old and legally able to consent
- Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment
- Weigh between 45-100 kg (females) or 50-100 kg (males).
- Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago
Key exclusion criteria (6 listed)
- Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)
- Severe psychiatric issues or substance abuse in the past year
- Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)
- Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))
- Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bimekizumab regimen 1 ivParticipants will receive bimekizumab (BKZ) at pre-specified time points. | Drug | Bimekizumab arm 1 |
| Bimekizumab regimen 2 ivParticipants will receive bimekizumab (BKZ) at pre-specified time points. | Drug | Bimekizumab arm 1 |
| Bimekizumab regimen 3 scParticipants will receive bimekizumab (BKZ) at pre-specified time points. | Drug | Bimekizumab arm 2 |
Primary outcome
Steady-state Trough Concentration (Ctrough,ss) at Week 16
Time frame: Week 16
Steady-state trough concentration (Ctrough,ss) will be reported.
3 secondary outcomes
Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit
Time frame: From Baseline to the end of SFU Visit (up to Week 29)
Occurrence of treatment-emergent Serious Adverse Events (SAEs) from Baseline to the end of SFU Visit
Time frame: From Baseline to the end of SFU Visit (up to Week 29)
Occurrence of TEAEs leading to withdrawal of study intervention
Time frame: From Baseline to the end of SFU Visit (up to Week 29)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. The sponsor does not plan to share IPD.
Related trials for Psoriatic Arthritis
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Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
Enrolling by invitation
Combined High-Intensity Aerobic Training and Resistance Training in Psoriatic Arthritis
Psoriatic Arthritis
Not yet recruiting
Definition of Novel Optoacoustic Biomarkers of Psoriasis and Psoriatic Arthritis
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Active, not recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
UCB Cares contact
UCB Cares study director
001 844 599 22733 (UCB)
63 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bimekizumab regimen 1 iv, Bimekizumab regimen 2 iv and Bimekizumab regimen 3 sc in people with Psoriatic Arthritis and Axial Spondyloarthritis, run by UCB Biopharma SRL at 63 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Poland, Bulgaria, Czechia, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCB Cares (+18445992273, ucbcares@ucb.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steady-state Trough Concentration (Ctrough,ss) at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.