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Abt-494

Clinical trials of Abt-494 are studying its use in adults with axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis. The trials aim to assess how well it works, how safe it is, and how well people tolerate it. They focus on adults with active disease, including some who did not respond to biologic DMARDs.

Table of contents

Clinical trial overview

The main study of Abt-494 in the provided data is NCT04169373, a Phase 3 interventional trial in adults with axial spondyloarthritis.[1]

This trial was completed and enrolled 690 people.[1]

The study looked at adults with active disease, including people with ankylosing spondylitis who had an inadequate response to biologic DMARDs in one study group, and people with non-radiographic axial spondyloarthritis in another study group.[1]

Study design and who was included

The trial compared Abt-494 15 mg taken by mouth with a matching placebo, which is a look-alike treatment with no active study medicine.[1]

This kind of design helps researchers see whether any improvement is more likely due to the study medicine and not to chance.[1]

The trial focused on adults with active axial spondyloarthritis, so the people in the study were not healthy volunteers; they had ongoing symptoms and inflammation from this disease.[1]

One part of the study included subjects with active ankylosing spondylitis who had not responded well enough to biologic DMARDs, often called bDMARD-IR.[1]

The other part included subjects with active non-radiographic axial spondyloarthritis.[1]

What the trial measured

The main endpoint, or main result the study wanted to measure, was ASAS 40 response at week 14 in both study groups.[1]

ASAS 40 is a standard measure in axial spondyloarthritis research. It means a 40% improvement in signs and symptoms based on a set of clinical questions and assessments.[1]

The trial also assessed safety and tolerability, which means whether the treatment caused problems and how well people could take it during the study.[1]

These outcomes matter because patients and researchers need to know both whether a treatment works and whether it can be used safely in the study setting.[1]

What the trial results mean for patients

This study was designed to answer a practical question: can Abt-494 reduce symptoms and improve disease activity in adults with active axial spondyloarthritis better than placebo?[1]

Because the trial included both ankylosing spondylitis and non-radiographic axial spondyloarthritis, it covered two important patient groups within the same disease family.[1]

The week 14 endpoint shows that the researchers looked for relatively early improvement after treatment started.[1]

Since the study was completed, it adds to the evidence about how Abt-494 performs in a larger group of adults with this inflammatory spine disease.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04169373 Phase 3 Axial spondyloarthritis Completed 690

FAQ

  • What condition is being studied in Abt-494 trials? The trial is studying axial spondyloarthritis, a group of inflammatory spine diseases. It includes ankylosing spondylitis and non-radiographic axial spondyloarthritis.
  • Who can take part in these trials? The trial includes adult subjects with active axial spondyloarthritis. One study group includes people with ankylosing spondylitis who did not respond to biologic DMARDs, which are advanced medicines used for inflammatory disease.
  • What phase is the Abt-494 trial? This is a Phase 3 trial. Phase 3 studies usually test how well a treatment works and continue to look at safety in a larger group of people.
  • What is the main goal of the trial? The main goal is to compare Abt-494 with placebo to see if it reduces signs and symptoms of active disease. The trial also checks safety and tolerability.
  • What result is the trial measuring? The main result is ASAS 40 response at week 14. This means the trial checks whether there is at least a 40% improvement in symptoms and signs based on a standard spine-disease measure.

Ongoing Clinical Trials on Abt-494

  • Study on Upadacitinib for Adults with Active Axial Spondyloarthritis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Hungary +3

Glossary

  • Axial spondyloarthritis: A group of long-term inflammatory diseases that mainly affect the spine and the joints near the pelvis.
  • Ankylosing spondylitis: A type of axial spondyloarthritis that can cause pain and stiffness in the spine.
  • Non-radiographic axial spondyloarthritis: A form of axial spondyloarthritis where X-rays do not yet show clear damage, but symptoms and other tests still suggest the disease.
  • Active disease: The illness is causing current symptoms and inflammation.
  • Biologic DMARD: A biologic disease-modifying antirheumatic drug. This is a medicine used to treat inflammatory diseases by changing how the immune system works.
  • bDMARD-IR: Biologic DMARD inadequate response. This means the person did not improve enough with a biologic medicine.
  • Placebo: A look-alike treatment with no active study medicine. It is used to compare results fairly.
  • Phase 3: A late-stage trial that tests how well a treatment works in a larger group and continues safety checks.
  • ASAS 40 response: A standard trial measure showing at least 40% improvement in symptoms and signs of axial spondyloarthritis.
  • Week 14: The 14th week after the trial treatment starts, when the main result is measured.

References