Lebrikizumab for Prurigo Nodularis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of lebrikizumab for individuals with Prurigo Nodularis (PN), a skin condition characterized by very itchy, hard bumps. Participants will receive lebrikizumab injections to determine if it reduces moderate-to-severe itching and the number of nodules on their body. This trial may suit adults who have experienced PN for at least a year and are dealing with significant itching and multiple nodules in various areas. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop using other treatments for Prurigo Nodularis and drugs that affect the immune system during the study and within 4 weeks before starting. If you're on such medications, you may need to stop them before participating.
Is there any evidence suggesting that lebrikizumab is likely to be safe for humans?
Research has shown that lebrikizumab is generally well-tolerated. In studies for conditions like atopic dermatitis (a type of eczema), it demonstrated good safety results. Common side effects include mild issues such as eye problems (like conjunctivitis and keratitis) and allergic reactions, occurring in more than 1% of patients.
Warnings exist about parasitic infections and vaccination issues, but these risks are considered manageable. Lebrikizumab's safe use for other conditions provides some confidence about its safety for prurigo nodularis, although more information is needed.
This trial has reached a stage where some safety data from human studies is available, but further research continues to ensure safety for everyone.12345Why do researchers think this study treatment might be promising for Prurigo Nodularis?
Researchers are excited about Lebrikizumab for treating Prurigo Nodularis because it targets a specific protein called IL-13, which plays a key role in the inflammatory process that triggers this skin condition. Unlike current treatments that often use broad immunosuppressants or topical steroids, Lebrikizumab offers a more targeted approach, potentially reducing side effects and improving efficacy. This biologic drug is administered through subcutaneous injections, which may offer more convenience and consistency compared to creams or oral medications.
What evidence suggests that lebrikizumab might be an effective treatment for Prurigo Nodularis?
Research has shown that lebrikizumab, the investigational treatment in this trial, may help treat prurigo nodularis (PN), a skin condition. Earlier studies found that it reduced itching and helped control the disease for a long time, even after stopping the treatment. In one study, 17.2% of patients felt less itchy within 48 hours, compared to only 3.7% who took a placebo (a non-active treatment). Lebrikizumab has also proven effective and well-tolerated in treating similar skin issues like atopic dermatitis. These results suggest that lebrikizumab could be a helpful treatment for people with moderate-to-severe PN.12367
Who Is on the Research Team?
Kristin L Khan, MD
Principal Investigator
University of Maryland, Baltimore
Are You a Good Fit for This Trial?
This trial is for adults with moderate-to-severe Prurigo Nodularis, a skin condition causing itchy bumps. Participants should have significant symptoms and meet other health requirements set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous injections of Lebrikizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lebrikizumab
Trial Overview
The study is testing lebrikizumab, an injectable medication, to see how well and how quickly it helps people with Prurigo Nodularis. All participants will receive this treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive subcutaneous injections of Lebrikizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
Emerging Therapies in the Treatment of Prurigo Nodularis
Secondary outcomes showed improved pruritus scores and long-term disease control post treatment cessation. These findings underline its ...
Real-World Effectiveness of Lebrikizumab for the Prurigo ...
Clinical trials and real-world studies have demonstrated its effectiveness and good tolerability for moderate-to-severe AD.3,4,5 However, data on the ...
Efficacy and Speed of Response of Lebrikizumab in High- ...
The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).
NEMLUVIO® Clinical Trial Results for Prurigo Nodularis
Results were achieved at 48 hours in 17.2% of patients with NEMLUVIO vs 3.7% with placebo. Data are from pooled post-hoc analysis of daily itch improvement ...
Dupilumab in patients with prurigo nodularis
Dupilumab demonstrated clinically meaningful and statistically significant improvements in itch and skin lesions versus placebo in PN.
Clinical Data | EBGLYSS® (lebrikizumab-lbkz) - Eli Lilly
Warnings and precautions include hypersensitivity reactions, conjunctivitis and keratitis, parasitic (helminth) infections, and vaccinations. Most common (≥1%) ...
7.
dermatologytimes.com
dermatologytimes.com/view/late-breaking-data-lebrikizumab-demonstrates-efficacy-in-ad-patients-with-skin-of-colorLate-Breaking Data: Lebrikizumab Demonstrates Efficacy ...
Lebrikizumab showed significant efficacy in improving EASI and Pruritus NRS scores in patients with pigmented skin and moderate to severe AD.
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