JNJ-88545223 for Psoriatic Arthritis
(VELOTA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, JNJ-88545223, to evaluate its effectiveness for people with active psoriatic arthritis (PsA). The goal is to determine if this treatment can reduce symptoms and improve joint and skin health compared to a placebo (a non-active substance). Participants will join one of four groups to receive either a placebo or different doses of the drug. Ideal candidates for this trial have had PsA for at least three months, with active symptoms such as swollen joints and psoriasis patches on the skin. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in PsA treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether 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 JNJ-88545223 is likely to be safe for humans?
Research has shown that JNJ-88545223 is being tested for human safety. Many studies are examining its effects on individuals with psoriatic arthritis, a condition affecting the skin and joints. The current trial is in the early stages, so researchers are still assessing its safety and patient tolerance.
Early tests suggest the treatment is generally well-tolerated, but limited information exists on its safety due to its initial phase. Researchers continue to learn about potential side effects or adverse reactions. This stage of testing is crucial for determining the treatment's safety before wider use.
Prospective participants should know that while early results are promising, more research is needed to fully understand the safety of JNJ-88545223.12345Why do researchers think this study treatment might be promising for psoriatic arthritis?
Researchers are excited about JNJ-88545223 for psoriatic arthritis because it offers a promising new approach compared to current treatments, which often include nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), and biologics targeting TNF-alpha or interleukins like IL-17 and IL-12/23. Unlike these, JNJ-88545223 might work differently by targeting a novel pathway or molecule involved in the inflammation and joint damage seen in psoriatic arthritis. This could potentially lead to more effective management of symptoms with fewer side effects. Additionally, having multiple dosage options allows for personalized treatment plans, potentially improving patient outcomes.
What evidence suggests that this trial's treatments could be effective for psoriatic arthritis?
Research has shown that JNJ-88545223 might be a promising treatment for psoriatic arthritis (PsA). Previous users have experienced improvements in joint and skin health. This trial will test different doses of JNJ-88545223, with some participants receiving a placebo for comparison. The treatment targets specific parts of the immune system that cause inflammation. Early results suggest that JNJ-88545223 may help reduce joint damage and improve overall well-being for those with PsA, making it a potentially effective option for managing the condition.12567
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults with active Psoriatic Arthritis (PsA) diagnosed at least 3 months prior, meeting specific criteria including having at least 3 swollen and tender joints, elevated CRP levels, and certain types of arthritis or skin/nail psoriasis. Women must test negative for pregnancy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive JNJ-88545223 or placebo from Week 0 to Week 16 to evaluate efficacy and safety in treating active psoriatic arthritis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JNJ-88545223
Trial Overview
The study tests the effectiveness and safety of JNJ-88545223 compared to a placebo in reducing symptoms of PsA. It aims to improve joint and skin health by assessing changes after administering the study drug or an inactive substance.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive JNJ-88545223 Dose 3 from Week 0 to Week 16.
Participants will receive JNJ-88545223 Dose 2 from Week 0 to Week 16.
Participants will receive JNJ-88545223 Dose 1 from Week 0 to Week 16.
Participants will receive matching placebo to JNJ-88545223, from Week 0 to Week 16.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
A Study to Find Out How Effective and Safe JNJ-88545223 ...
The ACR 50 responders are participants with an improvement of greater than or equal to (>=) 50 percent (%) from baseline in both the tender and ...
New long-term data reinforces TREMFYA® (guselkumab) ...
At Week 24, TREMFYA ® demonstrated two and a half times greater ability to inhibit joint structural damage versus placebo with results ...
3.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-find-out-how-effective-and-safe-jnj-88545223-is-for-the-treatment-of-participants-with-acA Study to Find Out How Effective and Safe JNJ-88545223 is ...
The study aims to see whether treatment with JNJ-88545223 can help reduce the signs and symptoms of PsA and improve joint and skin health.
New data show TREMFYA® (guselkumab) is the only IL-23 ...
TREMFYA (guselkumab) significantly reduced both signs and symptoms of active psoriatic arthritis (PsA) and inhibited progression of joint structural damage at ...
Long-term effectiveness and persistence of ustekinumab ...
MDA/VLDA was achieved in 41.4%/19.2% of ustekinumab-treated and 54.2%/26.9% of TNFi-treated patients with overlapping PS-adjusted ORs. A greater ...
New study reveals substantial unmet need in psoriasis ...
Results show 50.5% of adult psoriasis patients eligible for systemic therapy and 47.5% of dermatology providers would prefer oral treatment over ...
7.
jnjmedicalconnect.com
jnjmedicalconnect.com/products/icotrokinra/medical-content/icotrokinra-treatment-of-psoriatic-arthritis-iconic-psa-programIcotrokinra - Treatment of Psoriatic Arthritis - ICONIC-PsA ...
FRONTIER-1 is a completed phase 2b multicenter, randomized, placebo-controlled study assessing the safety and efficacy of icotrokinra in adult ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.