NCT07290036

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for phase_1

Timeline
29mo left

Started Dec 2025

Typical duration for phase_1

Geographic Reach
4 countries

42 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Dec 2025Sep 2028

First Submitted

Initial submission to the registry

December 4, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

December 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

December 4, 2025

Last Update Submit

April 23, 2026

Conditions

Psoriatic ArthritisAxial Spondyloarthritis

Keywords

Bimekizumab, BKZ, Phase 1B

Outcome Measures

Primary Outcomes (1)

  • Steady-state Trough Concentration (Ctrough,ss) at Week 16

    Steady-state trough concentration (Ctrough,ss) will be reported.

    Week 16

Secondary Outcomes (3)

  • Occurrence of treatment-emergent Adverse Events (TEAEs) from Baseline to the end of Safety Follow-Up (SFU) Visit

    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

    From Baseline to the end of SFU Visit (up to Week 29)

  • Occurrence of TEAEs leading to withdrawal of study intervention

    From Baseline to the end of SFU Visit (up to Week 29)

Study Arms (2)

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.

Drug: Bimekizumab regimen 1 ivDrug: 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.

Drug: Bimekizumab regimen 3 sc

Interventions

Bimekizumab regimen 1 ivDRUG

Participants will receive bimekizumab (BKZ) at pre-specified time points.

Bimekizumab arm 1
Bimekizumab regimen 2 ivDRUG

Participants will receive bimekizumab (BKZ) at pre-specified time points.

Bimekizumab arm 1
Bimekizumab regimen 3 scDRUG

Participants will receive bimekizumab (BKZ) at pre-specified time points.

Bimekizumab arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

Pa0019 114

Peoria, Arizona, 85381-5025, United States

RECRUITING

Pa0019 127

Apple Valley, California, 92307, United States

RECRUITING

Pa0019 111

Covina, California, 91722, United States

RECRUITING

Pa0019 117

Riverside, California, 92518, United States

RECRUITING

Pa0019 125

San Leandro, California, 94578, United States

RECRUITING

Pa0019 126

Temecula, California, 92592, United States

RECRUITING

Pa0019 120

Whittier, California, 90602, United States

RECRUITING

Pa0019 128

Whittier, California, 90602, United States

RECRUITING

Pa0019 123

Fort Collins, Colorado, 80528, United States

RECRUITING

Pa0019 113

South Miami, Florida, 33155, United States

RECRUITING

Pa0019 132

Chicago, Illinois, 60661, United States

RECRUITING

Pa0019 134

Lansing, Michigan, 48911, United States

RECRUITING

Pa0019 140

West Long Branch, New Jersey, 07764-1503, United States

RECRUITING

Pa0019 131

Albuquerque, New Mexico, 87102, United States

RECRUITING

Pa0019 115

Duncansville, Pennsylvania, 16635, United States

RECRUITING

Pa0019 142

Rock Hill, South Carolina, 29732, United States

RECRUITING

Pa0019 116

Jackson, Tennessee, 38305, United States

RECRUITING

Pa0019 129

Baytown, Texas, 77521, United States

RECRUITING

Pa0019 136

Colleyville, Texas, 76034, United States

RECRUITING

Pa0019 135

Mesquite, Texas, 75150, United States

RECRUITING

Pa0019 124

Plano, Texas, 75075, United States

RECRUITING

Pa0019 121

Bellevue, Washington, 98004, United States

RECRUITING

Pa0019 145

Spokane Valley, Washington, 99216, United States

RECRUITING

Pa0019 130

Beckley, West Virginia, 25801, United States

RECRUITING

Pa0019 205

Pleven, Bulgaria

RECRUITING

Pa0019 201

Plovdiv, Bulgaria

RECRUITING

Pa0019 202

Plovdiv, Bulgaria

RECRUITING

Pa0019 203

Plovdiv, Bulgaria

RECRUITING

Pa0019 301

Hamburg, Germany

RECRUITING

Pa0019 302

Ratingen, Germany

RECRUITING

Pa0019 407

Bialystok, Poland

RECRUITING

Pa0019 418

Bialystok, Poland

RECRUITING

Pa0019 401

Elblag, Poland

RECRUITING

Pa0019 412

Krakow, Poland

RECRUITING

Pa0019 410

Lublin, Poland

RECRUITING

Pa0019 417

Olsztyn, Poland

RECRUITING

Pa0019 406

Poznan, Poland

RECRUITING

Pa0019 408

Poznan, Poland

RECRUITING

Pa0019 411

Poznan, Poland

RECRUITING

Pa0019 415

Płońsk, Poland

RECRUITING

Pa0019 414

Warsaw, Poland

RECRUITING

Pa0019 420

Wroclaw, Poland

RECRUITING

MeSH Terms

Conditions

Arthritis, PsoriaticAxial Spondyloarthritis

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesAnkylosis

Study Officials

  • UCB Cares

    001 844 599 22733 (UCB)

    STUDY DIRECTOR

Central Study Contacts

UCB Cares

CONTACT

+18445992273ucbcares@ucb.com

UCB Cares

CONTACT

+18445992273

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

December 10, 2025

Primary Completion (Estimated)

May 18, 2028

Study Completion (Estimated)

September 14, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

The sponsor does not plan to share IPD.

Locations

US(24)DE(2)PL(12)BU(4)