The main aim of this study is to assess real-world effectiveness of nemolizumab in Prurigo nodularis (PN) as measured by investigator and patient reported outcome (PRO) in clinical practice at Month 6.
This prospective, multicenter, non-interventional study (NIS) seeks to evaluate PN treatment with nemolizumab (Nemluvio®) in adults over an approximately 12 month period using physician assessments in routine clinical practice and PRO measures. Treatment with nemolizumab will be determined solely by the participant's physician prior to study enrollment. No additional visits, procedures, or laboratory tests are required outside of routine clinical practice. The visit structure is not defined by the study protocol but is determined by routine medical practice. The visit schedule is intended to facilitate a systematic data assessment according to clinical routine. A sub-study will be completed in Germany and the UK at selected sites in which participants will complete the Peak pruritus (PP) numerical rating scale (NRS) and Sleep Disturbance (SD) NRS on a daily basis from Day -1 to Day 14. Data collection will occur remotely and no clinic visits will be required.
Study Type
OBSERVATIONAL
Enrollment
600
Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) at Month 6
The IGA-CPG stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the physician. In this scale, nodules, papules, plaques, and other PN lesions are defined as pruriginous lesions or chronic prurigo lesions. A single score will be determined by the physician as follows: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), or 4 (severe). A higher score indicates severe chronic prurigo.
Time frame: At 6 month
Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6
The PP NRS is a single-question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.
Time frame: At 6 month
Investigator Global Assessment-chronic Prurigo (IGA-CPG stage) Up to Month 12
The IGA-CPG stage is an instrument used to assess the overall number and thickness of chronic prurigo lesions at a given time point, as determined by the physician. In this scale, nodules, papules, plaques, and other PN lesions are defined as pruriginous lesions or chronic prurigo lesions. A single score will be determined by the physician as follows: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), or 4 (severe). A higher score indicates severe chronic prurigo.
Time frame: Up to 12 months
Prurigo Activity Score (PAS) Up to Month 12
The PAS is a physician-assessed tool to monitor the distribution and activity of chronic prurigo lesions. This includes a count of the number of lesions in a representative area and a calculated staging (stage 0 to stage 4) based on the percentage of lesions with excoriations/crusts and healed lesions compared to all lesions. A higher score indicates higher level of activity.
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Galderma Investigational Site # 8893
Birmingham, Alabama, United States
RECRUITINGGalderma Investigational Site # 7077
Phoenix, Arizona, United States
RECRUITINGGalderma Investigational Site # 7060
Phoenix, Arizona, United States
RECRUITINGGalderma Investigational Site # 7067
Tucson, Arizona, United States
RECRUITINGGalderma Investigational Site # 7074
Corona, California, United States
RECRUITINGGalderma Investigational Site # 6836
Fountain Valley, California, United States
RECRUITINGGalderma Investigational Site # 8224
Fremont, California, United States
RECRUITINGGalderma Investigational Site # 7064
Santa Monica, California, United States
RECRUITINGGalderma Investigational Site # 7061
Castle Rock, Colorado, United States
RECRUITINGGalderma Investigational Site # 7059
Fairfield, Connecticut, United States
RECRUITING...and 41 more locations
Time frame: Up to 12 months
Peak Pruritus Numerical Rating Scale (PP NRS) Up to Month 12
The PP NRS is a single-question validated PRO assessment that participants will use to report the maximum intensity of their pruritus (itch). The PP NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Here, a lower score indicates a better outcome.
Time frame: Up to 12 months
Sleep Disturbance Numerical Rating Scale (SD NRS) Up to Month 12
The SD NRS is a single-item PRO for quantifying sleep disturbance that has been validated in PN participants. The SD NRS consists of the following question: "On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of my skin disease (prurigo nodularis)', how would you rate your sleep last night". Here, a lower score indicates a better outcome.
Time frame: Up to 12 months