Ponesimod for Plaque Psoriasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ponesimod to determine its safety and effectiveness for individuals with moderate-to-severe chronic plaque psoriasis. Plaque psoriasis causes red, scaly patches on the skin. The study aims to discover if ponesimod can reduce these symptoms. Individuals diagnosed with this type of psoriasis, with noticeable patches covering at least 10% of their body, may be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, giving participants an opportunity to contribute to the potential availability of a new treatment.
Is there any evidence suggesting that ponesimod is likely to be safe for humans?
In a previous study, researchers tested ponesimod on patients with chronic plaque psoriasis. The study showed that ponesimod was generally well-tolerated, with most patients handling it well. Many patients experienced improvements in their symptoms. Safety records indicated that common side effects included headaches and flu-like symptoms, which were usually mild and manageable, not causing serious problems.
Another study found similar results, showing that the side effects resembled those seen with other treatments. The FDA has already approved ponesimod for a different condition, providing a known safety record. This approval offers extra reassurance about its safety in humans.12345Why do researchers think this study treatment might be promising?
Ponesimod is unique because it offers a new approach to treating plaque psoriasis by specifically targeting the S1P1 receptor, which plays a role in regulating immune cell movement. Unlike current treatments, such as biologics and traditional systemic therapies that broadly suppress the immune system, ponesimod's selective targeting may lead to fewer side effects and more precise management of the condition. Researchers are excited about the potential for ponesimod to provide a more focused treatment option, improving patient outcomes while minimizing the impact on overall immune function.
What evidence suggests that ponesimod might be an effective treatment for plaque psoriasis?
Research has shown that ponesimod effectively treats moderate-to-severe chronic plaque psoriasis. In one study, 71.4% of patients taking 20 mg of ponesimod experienced significant improvement, known as PASI75, by week 28. Another study found that by week 16, 46% of patients on 20 mg and 48% on 40 mg of ponesimod also achieved PASI75, meaning their psoriasis symptoms were reduced by at least 75%. These results suggest that ponesimod can greatly reduce psoriasis symptoms for many patients.12356
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with moderate-to-severe plaque psoriasis affecting at least 10% of their body. Participants need a certain severity score and must have a BMI between 18 and 40.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ponesimod for the treatment of moderate-to-severe chronic plaque psoriasis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ponesimod
Trial Overview
The study tests ponesimod, an oral medication, to see how safe and effective it is for treating moderate-to-severe chronic plaque psoriasis. All participants receive the drug in this open-label trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Ponesimod
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanda Pharmaceuticals
Lead Sponsor
Citations
Oral ponesimod in patients with chronic plaque psoriasis
Of 219 patients who entered the maintenance period, PASI75 was achieved by week 28 in 35 (71·4%) of 49 who continued on 20 mg ponesimod and 41 (77·4%) of 53 on ...
Oral ponesimod in patients with chronic plaque psoriasis
Of 219 patients who entered the maintenance period, PASI75 was achieved by week 28 in 35 (71·4%) of 49 who continued on 20 mg ponesimod and 41 (77·4%) of 53 on ...
119 Time Course of Efficacy of Ponesimod in Patients with ...
Ponesimod, a ・ was shown to be effective at significantly improving symptoms of moderate-to-severe chronic plaque psoriasis ・ at least a 75% reduction of the ...
NCT07362017 | Open Label Study to Investigate the Safety ...
Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis
5.
hmpgloballearningnetwork.com
hmpgloballearningnetwork.com/site/pln/articles/oral-ponesimod-relieves-chronic-plaque-psoriasisOral Ponesimod Relieves Chronic Plaque Psoriasis
At week 16, a drop in PASI score from baseline of at least 75% (PASI75) was achieved by 46% and 48% of patients taking 20 mg and 40 mg ponesimod ...
6.
fiercebiotech.com
fiercebiotech.com/biotech/actelion-s-ponesimod-successful-mid-stage-trial-patients-moderate-to-severe-chronic-plaqueActelion's ponesimod successful in mid-stage trial ...
Results of the primary endpoint were highly statistically significant with both tested doses. With Ponesimod 20 mg, 46 % of patients improved by ...
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