Tildrakizumab for Psoriatic Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called tildrakizumab for individuals with active psoriatic arthritis (PsA), a condition causing joint pain and skin issues. The researchers aim to determine the effectiveness and safety of this treatment compared to a placebo, a non-active substance. Participants should have had active PsA for at least six months and must not have previously used anti-TNF treatments. Those who meet these criteria and seek new treatment options might consider this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.
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 study team or your doctor to get a clear answer.
Is there any evidence suggesting that tildrakizumab is likely to be safe for humans?
Research has shown that tildrakizumab remains as safe as in past studies for treating plaque psoriasis, with no new safety issues identified in trials involving individuals with psoriatic arthritis. In these studies, patients taking tildrakizumab generally showed more improvement than those on a placebo, with no unexpected side effects.
The FDA has already approved tildrakizumab for treating plaque psoriasis, indicating it is generally well-tolerated based on existing data. Prospective trial participants can find reassurance in this information regarding the treatment's safety.12345Why do researchers think this study treatment might be promising for psoriatic arthritis?
Tildrakizumab is unique because it specifically targets the interleukin-23 (IL-23) pathway, which plays a crucial role in the inflammatory process of psoriatic arthritis. Most current treatments, like TNF inhibitors, focus on blocking tumor necrosis factor (TNF) to reduce inflammation. By targeting IL-23, Tildrakizumab offers a novel mechanism of action that may provide relief for patients who do not respond well to existing therapies. Researchers are excited about Tildrakizumab because it has the potential to be more effective for certain patients and might offer a different safety profile compared to traditional therapies.
What evidence suggests that tildrakizumab might be an effective treatment for PsA?
Research has shown that tildrakizumab, which participants in this trial may receive, may help treat psoriatic arthritis (PsA). Studies found that many patients using tildrakizumab experienced a 20% improvement in their symptoms, which is encouraging. The treatment effectively addresses both joint and skin symptoms related to PsA. Overall, these results suggest that tildrakizumab could be a good option for managing PsA symptoms.13567
Are You a Good Fit for This Trial?
This trial is for adults diagnosed with active Psoriatic Arthritis (PsA) for at least 6 months, who have never used anti-TNF treatments. Participants must test negative for certain antibodies and agree to use effective contraception if of childbearing potential. Exclusions include a history of serious infections, heart issues within the past 6 months, drug abuse in the last two years, or any condition that might compromise study participation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tildrakizumab or placebo in a double-blind manner
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tildrakizumab
Tildrakizumab is already approved in European Union, United States for the following indications:
- Moderate to severe plaque psoriasis
- Moderate to severe plaque psoriasis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sun Pharma Global FZE
Lead Sponsor
Sun Pharmaceutical Industries Limited
Lead Sponsor
Dilip Shanghvi
Sun Pharmaceutical Industries Limited
Chief Executive Officer since 1993
Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor
Dr. Azadar H. Khan
Sun Pharmaceutical Industries Limited
Chief Medical Officer since 2023
MD from a recognized institution