PA0019

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

Brief summary

To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.

Medical Condition

Psoriatic Arthritis

Min. Age

18
Years

Max. Age

-

Who Can Join?

All

Status

Recruiting
Inclusion criteria

-  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

Exclusion criteria

- 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)

Study Medication Description

Study Medication:

Bimzelx®

Other Descriptive Name:

bimekizumab

Placebo

No

Comparator:

No

Study Dates

December 2025

Actual Start Date of Enrollment

September 2028

Planned Study Completion Date

General Information

Study ID:
PA0019
EudraCT Number:
2025-522782-30
CT.gov Number:
NCT07290036
Phase:
Phase 1

Interested in our clinical studies?

Just contact us

Austria

UCBCares.AT@ucb.com
+43 (0) 1 291 80 08
0800-296176 (freephone)

Belgium

UCBCares.BE@ucb.com
+32 2 559 92 00
0800 38 008 (freephone)
www.ucbcares.be

Bulgaria

Canada

+1 866 709 8444

Czech Republic

UCBCares.CZ@ucb.com
+420 221 773 442
800 144 395 (freephone)
www.ucbcares.cz

Denmark

UCBCares.DK@ucb.com
+45 32462480
80 253827 (freephone)
www.ucbcares.dk

Finland

UCBCares.FI@ucb.com
+358 942733300
0800 9 13353 (freephone)
www.ucbcares.fi

France

UCBCares.FR@ucb.com
+33 1 47 29 45 55
0 805 222 949 (freephone)
www.ucbcares.fr

Germany

Greece

UCBCares.GR@ucb.com
+30 21 0997 4200
0080 012 9910 (freephone)
www.ucbcares.gr

Hungary

UCBCares.HU@ucb.com
+36 1 472 5060
06 80 021 486 (freephone)
www.ucbcares.hu

Ireland

UCBCares.IE@ucb.com
+353 1 463 2371
1800 93 00 75 (freephone)
www.ucbcares.co.uk

Italy

UCBCares.IT@ucb.com
+39 02 3007 9300
8009-86932 (freephone)
www.ucbcares.it

Luxemburg

UCBCares.LU@ucb.com
+32 2 559 92 12
8002 3204 (freephone)

Norway

UCBCares.NO@ucb.com
+45 32462482
800-10101 (freephone)
www.ucbcares.no

Poland

UCBCares.PL@ucb.com
+48 22 596 97 97
00 800 121 68 25 (freephone)
www.ucbcares.pl

Portugal

UCBCares.PT@ucb.com
+351 213 025 300
800-8-56033 (freephone)

Romania

+4021 300 19 07

Slovakia

UCBCares.SK@ucb.com
+421 2 592 020 23
0800 002 566 (freephone)
www.ucbcares.sk

Spain

UCBCares.ES@ucb.com
+34 915 70 06 49
8000-99684 (freephone)
www.ucbcares.es

Sweden

UCBCares.SE@ucb.com
+45 32462481
0200 898 671 (freephone)
www.ucbcares.se

Switzerland

+41 58 822 3180

The Netherlands

UCBCares.NL@ucb.com
+31 76 573 1130
0800 3434335 (freephone)
www.ucbcares.nl

UK

UCBCares.UK@ucb.com
+44 1753 777 100
0800 279 3177 (freephone)
www.ucbcares.co.uk