The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).
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
Prior participation in a lebrikizumab study
History of anaphylaxis
History of or active HIV
Active hepatitis or known liver cirrhosis
Single group
Lebrikizumab
DrugParticipants 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.
Percent change from baseline in weekly average Peak Pruritus Numeric Rating Scale (PP-NRS) at week 24
The PP-NRS is a single-item measure assessing itch on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants will complete the PP-NRS daily, rating their worst level of itch during the past 24 hours.
Percentage of patients achieving an Investigator Global Assessment for Prurigo Nodularis Stage (IGA PN-S) score of 0 or 1
The percentage of patients achieving an IGA PN-S score of 0 or 1 with a ≥2-point reduction from baseline to Week 24. The IGA PN-S is a rating completed by the investigator during visits assessing the severity of the disease from 0 (Clear) to 4 (Severe)
Percentage of subjects achieving at least a 4-point reduction from baseline in weekly average PP-NRS at Week 24
The PP-NRS is a single-item measure assessing itch on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants will complete the PP-NRS daily, rating their worst level of itch during the past 24 hours.
Percent change from baseline in Dermatology Life Quality Index (DLQI) scores at week 24
The DLQI is a 10-item questionnaire used to assess the impact of skin disease on the quality of life of the affected person. The 10 questions are scored from 0 to 3, giving a possible total score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Completed by participants during study visits specified in the protocol.
Percent change from baseline in The Sleep Disturbance Numerical Rating Scale (SD-NRS) at week 24
The SD-NRS is a single-item measure assessing sleep disturbance on a scale from 0 ("no sleep disturbance") to 10 ("worst possible sleep disruption"). Participants will complete the SD-NRS daily, rating their sleep quality.
Percent change from baseline in 5D-Pruritus Scale at week 24
5-D pruritus' scale is a questionnaire assessing duration, degree, direction, disability, and distribution of the affected person's itch. Completed by participants during study visits specified in the protocol.
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University of Maryland, Baltimore
Lead sponsor
Eli Lilly and Company
Collaborator
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