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Study on Upadacitinib for Adults with Active Axial Spondyloarthritis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Upadacitinib on a condition known as Axial Spondyloarthritis. Axial Spondyloarthritis is a type of arthritis that primarily affects the spine and the joints connecting the spine to the pelvis, causing pain and stiffness. The study aims to evaluate how well Upadacitinib works in reducing the signs and symptoms of this condition and to assess its safety for patients.

Participants in the study will receive either Upadacitinib or a placebo, which is a substance with no active medication. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will also include a period where participants who respond well to the treatment will have their medication gradually withdrawn to observe if they can maintain remission, which is a state where symptoms are reduced or disappear.

The trial will be conducted over several weeks, with regular check-ups to monitor the participants' health and the effects of the medication. The primary goal is to see if Upadacitinib can significantly improve the condition of patients with Axial Spondyloarthritis compared to those who receive the placebo. Participants will be closely monitored for any side effects or changes in their condition throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, an initial visit is conducted to confirm eligibility. This involves a review of medical history and a physical examination.

    During this visit, the study procedures and requirements are explained, and informed consent is obtained.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, upadacitinib, or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

    This process is double-blind, meaning neither the participant nor the study team knows which treatment is being received.

  3. Step 3

    Treatment phase

    Participants take the assigned tablets orally once daily. The dosage and specific instructions are provided by the study team.

    Regular follow-up visits are scheduled to monitor health and assess the effectiveness of the treatment. These visits may include physical exams, questionnaires, and blood tests.

  4. Step 4

    Remission-withdrawal period

    If certain health criteria are met, participants may enter a remission-withdrawal period. This involves continuing the study medication while keeping other medications stable.

    Participants are closely monitored to ensure safety and to evaluate the long-term effects of the treatment.

  5. Step 5

    End of study

    At the end of the study, a final visit is conducted to assess overall health and gather final data.

    Participants are informed about the study results and any next steps regarding their treatment.

Who can join the trial?

12 criteria

  • Adult females and males who are at least 18 years of age.
  • Participants must not have any reason that makes them unsuitable for the study or puts them at risk by continuing in the study.
  • Participants must be willing to keep their current medications for axial spondyloarthritis (axSpA) stable during the study period.
  • Participants must understand and agree to follow all study requirements and sign a consent form approved by an ethics committee.
  • For Study 1: Participants must have a clinical diagnosis of Ankylosing Spondylitis (AS) and meet specific criteria known as the modified New York Criteria for AS.
  • For Study 1: Participants must have tried 1 or 2 biologic disease-modifying antirheumatic drugs (bDMARDs), which include at least one tumor necrosis factor (TNF) inhibitor or one interleukin (IL)-17 inhibitor, and stopped using them due to lack of effectiveness or intolerance.
  • For Study 2: Participants must have a clinical diagnosis of non-radiographic axial spondyloarthritis (nr-axSpA) and meet specific criteria, including signs of active inflammation on an MRI scan or high levels of a marker in the blood called CRP.
  • For Study 2: Participants may have been treated with at most one bDMARD, either a TNF inhibitor or an IL-17 inhibitor, in a certain percentage of cases.
  • Participants must have a BASDAI score of 4 or higher and a Patient's Assessment of Total Back Pain score of 4 or higher on a scale from 0 to 10 at the start of the study.
  • Participants must be on the study drug at the end of the Open-Label Extension Period of Study 1 or Study 2 through Week 104.
  • Participants must achieve an ASDAS (CRP) score of less than 1.3 at Week 104 and less than 2.1 at Week 88.
  • Participants must not have developed any new medical conditions or started new medications since the last dose of the study drug that would prevent them from continuing in the main study.

Who cannot join the trial?

9 criteria

  • Patients who have a history of severe allergic reactions to the study medication or similar medications cannot participate.
  • Patients with active infections, such as tuberculosis, cannot participate.
  • Patients with a history of cancer within the last 5 years, except for certain skin cancers, cannot participate.
  • Patients with liver disease or abnormal liver function tests cannot participate.
  • Patients with certain blood disorders, such as low white blood cell count, cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received certain treatments for their condition within a specific time frame before the study starts cannot participate.
  • Patients with a history of drug or alcohol abuse within the last year cannot participate.
  • Patients with other medical conditions that the study doctors believe would make participation unsafe cannot participate.
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Investigated drugs

Upadacitinib is a medication being studied for its ability to help reduce the signs and symptoms of a condition called axial spondyloarthritis, which affects the spine and joints. This medication works by targeting specific pathways in the immune system that are involved in inflammation. By doing so, it aims to decrease the inflammation and pain associated with this condition, potentially improving the quality of life for those affected. The trial is also assessing how safe and tolerable this medication is for people with this condition.

What is already known about the treatment

Upadacitinib – Upadacitinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness and safety in treating axial spondyloarthritis, a type of inflammatory arthritis affecting the spine and pelvic joints. The main therapeutic indication for upadacitinib is to reduce the signs and symptoms of active axial spondyloarthritis, including cases that have not responded well to other treatments. At the molecular level, upadacitinib works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Axial Spondyloarthritis – Axial Spondyloarthritis is a type of inflammatory arthritis that primarily affects the spine and the sacroiliac joints, which connect the lower spine to the pelvis. It is characterized by chronic back pain and stiffness, particularly in the lower back and buttocks. The disease often begins in early adulthood and can lead to reduced flexibility and mobility over time. Inflammation can cause new bone formation, leading to the fusion of vertebrae, which may result in a loss of spinal mobility. Symptoms can vary in intensity and may include fatigue and pain in other joints. The progression of the disease can lead to significant physical limitations if not managed properly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501018-78-00Protocol codeM19-944Estimated enrolment690 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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