Dupilumab for Prurigo Nodularis
(GLOBOSPIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the effectiveness of dupilumab for treating prurigo nodularis (PN), a skin condition that causes itchy lumps. Researchers aim to assess how well this treatment works in real-world settings and understand the lives of people using it. They seek adults diagnosed with PN who have already decided with their doctor to start using dupilumab. Those starting this treatment may be a good fit for the study. As a Phase 4 trial, this study focuses on understanding how this FDA-approved and proven effective treatment can benefit more patients, offering valuable insights into its real-world impact.
Do I have to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What is the safety track record for dupilumab therapy?
Research has shown that dupilumab is generally safe for people with prurigo nodularis (PN). Studies have found that most patients tolerate dupilumab well. The most common side effects are mild, such as reactions at the injection site, while serious side effects are rare. In one study, many people with PN experienced significant improvement in itching and skin problems after using dupilumab. This suggests it is both effective and safe for long-term use. The safety profile of dupilumab in these studies aligns with its known safety in treating other conditions, such as eczema.12345
Why are researchers excited about this trial?
Unlike the standard treatments for prurigo nodularis, which often focus on managing symptoms through topical corticosteroids or antihistamines, Dupilumab offers a new approach by targeting the immune system. It works by blocking specific proteins, IL-4 and IL-13, which play a key role in the inflammatory process that causes the itchy, bumpy skin associated with this condition. Researchers are excited because Dupilumab has been shown to provide significant relief for similar inflammatory skin conditions, suggesting it might offer more effective and long-lasting results for prurigo nodularis patients.
What is the effectiveness track record for dupilumab in treating prurigo nodularis?
Research has shown that dupilumab effectively treats prurigo nodularis (PN), a skin condition that causes itchy bumps. Studies have found that patients using dupilumab experience significantly less itchiness and fewer skin problems than those not using it. In one study, patients who received dupilumab showed better results in all tested areas compared to those who received a placebo. Additionally, the safety profile of dupilumab is consistent with its use in other skin conditions. These findings suggest that dupilumab is a promising option for managing PN symptoms. Participants in this trial will receive dupilumab according to country-specific prescribing information.12356
Who Is on the Research Team?
Clinical Sciences & Operations
Principal Investigator
Sanofi
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dupilumab therapy for prurigo nodularis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dupilumab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants aged 18 years or older who start receiving dupilumab for prurigo nodularis (according to the country-specific prescribing information) prior to and independently of their participation in the study
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School
Citations
Prurigo Nodularis
Find efficacy results and safety data in adult patients with prurigo nodularis (PN) using DUPIXENT® (dupilumab) as a treatment option.
Dupilumab for the treatment of prurigo nodularis
Dupilumab has been shown to be safer and more effective in controlling patients with PN in combination with other underlying diseases, even HIV infection or ...
Dupilumab in patients with prurigo nodularis
Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch and skin lesions versus placebo in PN.
Dupilumab improves pruritus and skin lesions in patients ...
Patients receiving dupilumab (n = 153) vs placebo (n = 158) experienced significant improvements in all tested endpoints.
Media Update: Positive data from two Phase 3 Dupixent® ...
Safety results through 24 weeks were generally consistent with the known safety profile of Dupixent in its approved dermatology indication.
NCT06087627 | A Non-interventional Study to Describe the ...
A Non-interventional Study to Describe the Dupilumab Long-term Treatment, Safety ... Outcomes in Chronic Nodular Prurigo (Prurigo Nodularis) in Clinical Routine.
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