Prurigo Nodularis (PN)SkinDrugPhase 2
What this study is
The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).
What's being tested
- Lebrikizumab
Intervention · DRUG
Participants will receive subcutaneous injections of Lebrikizumab every two weeks for 24 weeks. The first two doses will be 500 mg, and following doses will be 250 mg.
Study details
- Official title
- Evaluating the Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients: A 24-Week Study
- Sponsor
- University of Maryland, Baltimore
- Conditions
- Prurigo Nodularis (PN)
- Enrolling
- 15 people
- Starts
- 2026-09
- Est. completion
- 2028-03
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 18-80
- Diagnosis of Prurigo Nodularis (PN) for at least 1 year
- Active PN with moderate-to-severe itch, several nodules, and presence of nodules in more than one part of the body
- Women of childbearing potential must agree to remain abstinent or use a highly effective contraceptive method during treatment and for at least 18 weeks after the last dose of study drug
- Male participants must agree to use an effective barrier contraceptive if sexually active with a woman of childbearing potential during treatment and for at least 18 weeks after the last dose of study drug
You can't join if
- Prior participation in a lebrikizumab study
- History of anaphylaxis
- History of or active HIV
- Active hepatitis or known liver cirrhosis
- History of cancer in the past 5 years, except for fully treated early cervical cancer in situ or non-melanoma skin cancers (basal cell or squamous cell skin cancer) that have been successfully treated and resolved. This includes certain skin lymphomas such as mycosis fungoides.
- Uncontrolled chronic conditions that may require intermittent oral steroid use, such as severe uncontrolled asthma
- Current or recent parasitic infection
- Immunocompromised individuals
- Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study period
- Use of other treatments for PN during the study, such as topical, systemic, or light-based treatments
- Current or recent treatment with biologic drugs
- Use of drugs that have an effect on the immune system during the study and within 4 weeks of starting the study
- Receipt of phototherapy or light-based therapy within 4 weeks before starting the study
- Regular use of tanning booths or parlors within 4 weeks before starting the study
- Receipt of a live vaccine within 12 weeks before starting the study or planned receipt during the study
- Recent use of an experimental drug
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openUM Dermatology at UM Professional Building
Baltimore, Maryland, United States
- Brandon J Mangracina, MA · Contact732-757-5831bmangracina@som.umaryland.edu
- Marie Vidaver, PhD · Contact410-685-1726MVidaver@som.umaryland.edu
- Kristin L Khan, MD · Principal investigator
- Carolyn Stolte, CRNP · Sub-investigator
Study team
Sponsor
University of Maryland, Baltimore
Study ID J2T-NS-X002
Principal investigator
Kristin L Khan, MD
University of Maryland, Baltimore
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.