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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07620561). StuddyBuddy aggregates publicly available trial information.