Efficacy and Speed of Response of Lebrikizumab in High-Burden Prurigo Nodularis Patients

Browse trials for

• Prurigo 29
• Pruritus 352
• Dermatitis 1,435
• Skin Diseases 535

Keywords

• prurigo nodularis
• prurigo
• lebrikizumab
• ebglyss
• itch
• pruritus
• dermatitis
• skin diseases

Study arms

• Experimental
  Lebrikizumab

  Participants will receive subcutaneous injections of Lebrikizumab

  Drug: Lebrikizumab

Interventions

• DrugLebrikizumab

  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.

  Also known as: Ebglyss

Primary outcomes

1. 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.

   Time frame: Baseline; Week 24

2. 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)

   Time frame: Baseline; Week 24

Secondary outcomes

1. 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.

   Time frame: Baseline; Week 24

2. 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.

   Time frame: Baseline; Week 24

3. 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.

   Time frame: Baseline; Week 24

4. 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.

   Time frame: Baseline; Week 24

5. 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.

   Time frame: Baseline; Week 24

6. 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.

   Time frame: Baseline; Week 24

7. 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.

   Time frame: Baseline; Week 24