RightFit
RecruitingPhase 1

A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares bimekizumab given into a vein with bimekizumab given under the skin. It looks at safety and how the drug moves through the body over time. It is for adults with active psoriatic arthritis or axial spondyloarthritis.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and legally able to agree to join.
  • Have active psoriatic arthritis (joint swelling linked to psoriasis) or axial spondyloarthritis (arthritis mainly affecting the spine), and be suited for bimekizumab treatment.
  • Weigh 45–100 kg if female or 50–100 kg if male.
  • Have never used biologic drugs for arthritis, or have stopped them at least 3 months ago or for 5 drug half-lives. A half-life is the time it takes for half of a drug to leave the body.

Who can't join

  • Have a serious condition affecting organs such as the heart, liver, kidneys, digestive system, or nervous system.
  • Have had severe mental health problems or substance abuse in the past year.
  • Have a recent or long-term infection, including tuberculosis (TB) or an infection from related bacteria called NTMB.
  • Have another disease that causes inflammation, such as rheumatoid arthritis, lupus, or inflammatory bowel disease.
  • Have received a live vaccine within 8 weeks or the BCG vaccine for tuberculosis within 1 year.
  • Have used a GLP-1 agonist, a type of medicine used for diabetes or weight loss, within 28 weeks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (30)

AZ

CA

CO

FL

IL

MI

NJ

NM

OH

PA

SC

TN

TX

WA

WV