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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to evaluate the effectiveness of lebrikizumab in treating adults with moderate-to-severe Prurigo Nodularis (PN).
This study is a Phase II, single center, open-label, single-arm clinical trial. Study participation will last up to 32 weeks, including a 4-week screening period, a 24-week treatment period with all participants receiving lebrikizumab injections, and a 4-week safety follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lebrikizumab | Experimental | Participants will receive subcutaneous injections of Lebrikizumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lebrikizumab | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Week 24 |
| 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) | Baseline; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandon J Mangracina, MA | Contact | 732-757-5831 | bmangracina@som.umaryland.edu | |
| Marie Vidaver, PhD | Contact | 410-685-1726 | MVidaver@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kristin L Khan, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UM Dermatology at UM Professional Building | Baltimore | Maryland | 21201 | United States |
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| ID | Term |
|---|---|
| D011536 | Prurigo |
| D011537 | Pruritus |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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| 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. | Baseline; Week 24 |
| 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. | Baseline; Week 24 |
| 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. | Baseline; Week 24 |
| Percent change from baseline in Prurigo Activity Score (PAS) at week 24 | The PAS is a 7-item assessment completed by the investigator. The items of the PAS evaluate the type, number, distribution, size, and activity of skin lesions. | Baseline; Week 24 |
| Percent change from baseline in HADS anxiety and depression scale at week 24 | The Hospital Anxiety and Depression Survey is a questionnaire that evaluates and monitors mental health in adults. Completed by participants during study visits specified in the protocol. | Baseline; Week 24 |
| Percent change from baseline in Patient Global Impression of Change (PGIC) at week 24 | The PGIC is a questionnaire assessing overall satisfaction and perceived change due to treatment, ranging from "very much improved" to "very much worse". Completed by participants during study visits specified in the protocol. | Baseline; Week 24 |