Tulisokibart for Ankylosing Spondylitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a medicine called tulisokibart can help individuals with radiographic axial spondyloarthritis (r-axSpA), a type of arthritis that causes pain and stiffness in the spine and hips. Researchers are comparing different doses of tulisokibart to a placebo, a look-alike pill with no active medicine, to assess its effectiveness. The trial seeks participants who have experienced back pain for at least three months and have a diagnosis of r-axSpA, particularly those who haven't responded well to other treatments. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that tulisokibart is likely to be safe for humans?
Research has shown that tulisokibart has been safe in earlier studies. In one study involving individuals with Crohn's disease, tulisokibart was well tolerated, with most participants not experiencing serious side effects. Tulisokibart is now in Phase 2 trials for ankylosing spondylitis, where researchers continue to gather data on its safety and efficacy.
This phase evaluates the treatment's effectiveness and monitors for any side effects. The progression to this phase indicates that earlier studies did not identify major safety concerns. However, more information is needed to fully understand its safety for treating radiographic axial spondyloarthritis.12345Why do researchers think this study treatment might be promising for ankylosing spondylitis?
Tulisokibart is unique because it offers a new approach to treating ankylosing spondylitis. Unlike standard treatments like NSAIDs or TNF inhibitors, which primarily focus on reducing inflammation, tulisokibart targets a different pathway in the immune system. Researchers are excited because this novel mechanism could potentially provide relief to patients who don't respond well to existing therapies. Additionally, the ability to adjust doses, as seen in the trial with low, medium, and high doses, offers flexibility in treatment, which could lead to more personalized care for patients.
What evidence suggests that tulisokibart might be an effective treatment for ankylosing spondylitis?
Research has shown that tulisokibart may help reduce inflammation and pain in conditions like radiographic axial spondyloarthritis (r-axSpA). A previous study found that tulisokibart effectively treated inflammation in Crohn's disease and was generally well-tolerated. This suggests it might also work for r-axSpA, as both conditions involve immune-related inflammation. Tulisokibart is under study for several inflammatory diseases, indicating it could have broad applications. In this trial, researchers hope that different doses of tulisokibart—low, medium, and high—will improve r-axSpA symptoms compared to a placebo.12367
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults under 45 with a diagnosis of axial spondyloarthritis, visible on X-rays, who've had back pain for at least 3 months. They should have tried NSAIDs without success and either haven't used biologic drugs or only tried two types.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Placebo-controlled Period
Participants receive either a placebo or a dose of tulisokibart to evaluate efficacy and safety
Main Extension
Participants continue treatment with tulisokibart to assess long-term effects
Optional Extension
Participants may opt into continuation of treatment long-term
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tulisokibart
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University