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NCT07620561
Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients
Conditions: Prurigo Nodularis (PN)
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 15
Sponsor: University of Maryland, Baltimore
Location: UM Dermatology at UM Professional Building Baltimore Maryland
Summary
The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Other protocol-defined Inclusion/Exclusion Criteria apply.
Source: ClinicalTrials.gov (NCT07620561). StuddyBuddy aggregates publicly available trial information.