Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

A study comparing bimekizumab and adalimumab for treating chest pain in patients with active axial spondyloarthritis who do not respond well to non-steroidal anti-inflammatory drugs.

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study is designed to compare the effectiveness and safety of two different medications for people living with axial spondyloarthritis, a type of long-term inflammatory disease that primarily affects the spine and can cause pain and stiffness. Some individuals with this condition also experience psoriasis, a skin condition characterized by red, itchy, and scaly patches. A specific symptom being investigated is anterior chest wall pain, which is discomfort felt in the front of the chest area. This research focuses on patients whose symptoms have not improved sufficiently with the use of NSAIDs, which are common medicines used to reduce pain and swelling.

The study involves comparing the effects of bimekizumab (also referred to as BZK) and adalimumab (also referred to as ADA). Bimekizumab is a medication that works by blocking two specific proteins in the body that contribute to inflammation. The participants will receive one of these two treatments through an injection. During the course of the study, the way these medications manage pain and inflammation in the spine and chest area will be observed over several months.

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

    <b>treatment assignment</b>

    You will be assigned to receive one of two types of injection medications to treat axial spondyloarthritis, which is a type of inflammatory arthritis that primarily affects the spine and can cause chest wall pain.

  2. Step 2

    <b>medication administration</b>

    If assigned to the test group, you will receive bimekizumab at a dose of 160 mg via injection.

  3. Step 3

    <b>comparator administration</b>

    If assigned to the comparator group, you will receive adalimumab at a dose of 40 mg via injection.

  4. Step 4

    <b>pain monitoring</b>

    Throughout the study, you will use a digital tool to perform weekly self-evaluations of your spontaneous chest wall pain at different times of the day.

  5. Step 5

    <b>six-month evaluation</b>

    At the 6-month visit, your progress will be measured using the ASAS40 response. this measurement tracks if there is at least a 40% improvement in four specific areas: physical function, your overall assessment of disease activity, spine pain and inflammation, and morning stiffness.

Who can join the trial?

15 criteria

  • Both men and women who are between 18 and 60 years old can participate.
  • You must have a diagnosis of axial spondyloarthritis (SpA), which is a type of long-term inflammation that primarily affects the spine, with or without psoriasis (a skin condition that causes red, itchy patches).
  • The condition must have been present for more than 3 months.
  • You must not have previously used certain types of specialized medications called bDMARDs (biologic disease-modifying antirheumatic drugs) or JAK inhibitors (a class of drugs that block specific proteins to reduce inflammation).
  • You must have had an inadequate response to at least two NSAIDs (non-steroidal anti-inflammatory drugs, such as ibuprofen or naproxen) taken at a full dose for at least 2 weeks each, or you must be unable to take these medicines due to side effects for at least 3 months.
  • Your disease must be considered active, which is measured by a specific blood test score called ASDAS-CRP being 2.1 or higher.
  • You must experience spontaneous pain in the sacroiliac joints (the joints connecting the lower spine to the pelvis) rated at 4 out of 10 or higher on a pain scale.
  • You must have tenderness when pressure is applied to at least one of the four chondro-sternal joints (the joints where the ribs connect to the breastbone).
  • You must have had a stable dose of any current medications, such as painkillers, for at least the last month.
  • A doctor must have confirmed at least one clear sign of inflammation in the sacroiliac joints using imaging tests like an MRI (magnetic resonance imaging), ultrasonography (ultrasound), scintigraphy (a type of nuclear scan), or a CT scan (computed tomography) within the last 6 months.
  • You must have read and understood the study information and signed the consent form (a document agreeing to participate).
  • You must have health insurance or social security coverage.
  • Women who are able to become pregnant must use effective contraception (such as birth control pills, condoms, or diaphragms) starting one month before joining, during the study, and for 5 months after finishing the treatment.
  • Women who can become pregnant must also have a negative pregnancy test at the start of the study.
  • Women who are permanently sterile (unable to become pregnant due to surgery) or postmenopausal (meaning they have not had a period for 12 months or more) are also eligible.

Who cannot join the trial?

17 criteria

  • Being a pregnant woman.
  • Not meeting the required health checks before starting treatment, such as tests for viral serology (blood tests to check for viruses), oral health (teeth and mouth health), or checking for tuberculosis (a serious infection that usually affects the lungs).
  • Having an allergy or hypersensitivity (an extreme reaction) to the medicine or any of its excipients (the inactive ingredients used to make the medicine).
  • Having a serious active infection, such as tuberculosis or sepsis (a life-threatening reaction to an infection in the blood).
  • Having opportunistic infections (illnesses caused by germs that usually do not sicken healthy people but attack those with weakened immune systems).
  • Having moderate to severe heart failure, specifically NYHA classes III/IV (a classification used to describe how much heart disease limits a person's ability to do physical activities).
  • Being unable to have an MRI (a medical imaging test that uses strong magnets to take pictures of the inside of the body).
  • Being a person who is currently in jail or under judicial protection or guardianship (legal arrangements where a person is not fully responsible for their own decisions).
  • Taking part in another drug trial (a study testing new medicines) within the last 3 months.
  • Being a woman who can become pregnant and is not using contraception (methods used to prevent pregnancy).
  • Having a history of chest trauma (injury to the chest) or chest surgery.
  • Having a history of radiotherapy (using high doses of radiation to treat disease) in the front part of the chest.
  • Having received a cortisone derivative infiltration (an injection of a strong anti-inflammatory medicine) in the joints of the ACW (the sacroiliac joints, which connect the spine to the pelvis) within the last 3 months.
  • Meeting the medical criteria for fibromyalgia (a condition that causes widespread muscle pain and tenderness).
  • Having inflammatory bowel disease (IBD), which is a condition that causes long-term swelling in the digestive tract.
  • Having plaque psoriasis (a skin condition that causes red, itchy, and scaly patches) that is moderate or severe and requires high doses of certain medicines.
  • Using strong opioids (powerful pain medicines) at a daily dose higher than 30 mg of morphine (or a similar medicine) to manage pain.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Bimekizumab

    is a medication given by injection that works by blocking two specific proteins in the body, IL-17A and IL-17F, which are involved in causing inflammation. It is being tested to see if it can effectively treat pain in the front of the chest caused by active axial spondyloarthritis.

  • Adalimumab

    is a medication given by injection that is used as a comparison treatment in this study. It works by targeting and reducing certain parts of the immune system that contribute to inflammation in patients with axial spondyloarthritis.

What is already known about the treatment

  • Bimekizumab

    This medication is administered as an injection using a pre-filled syringe to treat inflammatory conditions like axial spondyloarthritis. It is a modern biologic drug that works by blocking two specific proteins in the body, IL-17A and IL-17F, which are responsible for causing inflammation. By stopping these proteins, the medicine helps reduce swelling and pain in the joints and muscles. It belongs to a class of drugs known as interleukin inhibitors.

  • Adalimumab

    This medicine is given as an injection to help manage various autoimmune and inflammatory diseases. It is a well-established biologic therapy that works by targeting and neutralizing a protein called tumor necrosis factor (TNF), which plays a major role in triggering inflammation. By reducing the activity of this protein, the drug helps decrease pain and stiffness in the body. It is pharmacologically classified as a TNF inhibitor.

Investigated diseases

Axial spondyloarthritis - This is a type of inflammatory disease that primarily affects the spine and the joints connecting the spine to the pelvis. It involves chronic inflammation that can lead to stiffness and pain in the back and neck. The condition often progresses by causing the joints to become less flexible over time. In some cases, it may be associated with skin conditions like psoriasis. The inflammation typically centers around the sacroiliac joints and the vertebral column.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520632-42-00Estimated enrolment150 patientsSponsorCentre Hospitalier Universitaire Rouen

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.