Rocatinlimab for Prurigo Nodularis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a new treatment, rocatinlimab, for prurigo nodularis, a skin condition that causes itchy bumps. The study compares rocatinlimab to a placebo (a substance with no active treatment) to determine if it can reduce itchiness and improve skin appearance. Participants will receive injections of either rocatinlimab or a placebo. The trial seeks adults who have had prurigo nodularis for at least three months, have tried creams or ointments without success, and have at least 20 nodules on their body. 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 requires that you stop taking any systemic biologic immunosuppressive or immunomodulatory therapy for prurigo nodularis or other autoimmune, inflammatory, or allergic diseases at least 12 weeks before starting the trial. If you are on such medications, you will need to stop them before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that rocatinlimab has been tested in earlier studies to assess its safety in humans. One study found serious side effects in 4% of people taking rocatinlimab, compared to 2% of those taking a placebo (a harmless pill used for comparison). This indicates that while some individuals might experience serious issues, these are not very common.
Researchers are also studying rocatinlimab for other conditions like asthma and skin problems, carefully monitoring its effects. As this treatment is in a later stage of testing, researchers have already gathered some safety information, indicating it's generally well-tolerated by most people. However, like any treatment, risks may still exist, which is why ongoing studies remain important.12345Why do researchers think this study treatment might be promising for prurigo nodularis?
Rocatinlimab is unique because it targets prurigo nodularis in a novel way by modulating the immune system differently than current treatments. While existing options like corticosteroids and antihistamines aim to reduce inflammation and itching, rocatinlimab works by specifically blocking certain pathways involved in the inflammatory response, potentially offering more targeted relief. Moreover, its administration via subcutaneous injection could improve patient compliance and convenience compared to some traditional therapies. Researchers are excited about rocatinlimab because it may provide more effective and rapid relief for those suffering from this chronic and often debilitating skin condition.
What evidence suggests that rocatinlimab might be an effective treatment for prurigo nodularis?
Research has shown that rocatinlimab offers promising results for treating prurigo nodularis and other skin conditions. In studies on atopic dermatitis, a similar condition, rocatinlimab reduced skin severity by up to 61%, significantly lessening symptoms. This trial will administer different doses of rocatinlimab or a placebo to evaluate its effectiveness for prurigo nodularis. Rocatinlimab proved much more effective than a placebo in previous studies, indicating the benefits are real and not by chance. This evidence suggests it could greatly help those with prurigo nodularis by addressing the root causes of their symptoms.12467
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for individuals with skin conditions like Atopic Dermatitis and Prurigo Nodularis, who experience severe itching. Participants should be willing to receive injections and not have any health issues that could interfere with the study or pose a risk when taking the trial medication.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period A
Participants receive either rocatinlimab or placebo subcutaneously
Treatment Period B
Participants continue receiving rocatinlimab or placebo, with an option for open-label rocatinlimab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rocatinlimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London