A Study of Lebrikizumab in Adults With Nummular Eczema

Browse trials for

• Dermatitis 1,435
• Skin Diseases 535

Keywords

• Nummular Eczema
• Dermatitis
• Skin Diseases
• Lebrikizumab

Study arms

• Experimental
  Placebo-controlled Period: Lebrikizumab

  Drug: Lebrikizumab

• Placebo comparator
  Placebo-controlled Period: Placebo

  Other: Placebo

• Experimental
  Blinded Extension Period: Lebrikizumab

  Drug: Lebrikizumab

• Experimental
  Blinded Extension Period: Lebrikizumab + Placebo

  Drug: Lebrikizumab · Other: Placebo

Interventions

• DrugLebrikizumab

  Lebrikizumab SC injection.

• OtherPlacebo

  Matching placebo SC injection.

Primary outcomes

1. Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24

   The IGA is an instrument used to globally rate the severity of a participants.

   Time frame: Baseline, Week 24

Secondary outcomes

1. Percentage of Participants with Pruritus Numerical Rating Scale (NRS) >=4 at Baseline Achieving a >=4-point Improvement in Pruritus NRS Score from Baseline at Week 24

   The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity during the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable".

   Time frame: Baseline, Week 24

2. Absolute Change from Baseline in Dermatology Quality of Life Index (DLQI) to Week 24

   The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.

   Time frame: Baseline up to Week 24

3. Percentage of Participants Achieving a 50 Percent (%) Reduction in Body Surface Area (BSA) from Baseline at Week 24

   BSA assessment estimates the extent of disease or skin involvement with respect to NE and is expressed as a percentage of total body surface. Body surface area will be determined by the Investigator or designee using the participant palm=1% BSA rule.

   Time frame: Baseline, Week 24

4. Absolute Change from Baseline in European Quality of Life Survey (EQ-5D-5L) at Week 24

   EQ-5D-5L is a standardised measure of health status that provides a profile of participant health on the day of questionnaire completion. It consists of 2 parts: a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression), each of which have 5 response levels of perceived problems, and a visual analogue scale scoring overall health on a scale from 0 (worst conceivable state of health) to 100 (best conceivable state of health).

   Time frame: Baseline, Week 24

5. Absolute Change from Baseline in Patient Global Assessment of Disease Status (PGADS) at Week 24

   PGADS measures static disease severity. Participants are asked "Considering all the ways in which your eczema affects you, indicate how well you are doing" and rate their overall well-being based on a 5-point Likert scale from 1 being "Poor" to 5 being "Excellent".

   Time frame: Baseline, Week 24

6. Absolute Change in Skin Pain NRS Score from Baseline at Week 24

   The Skin Pain NRS is a two-item measure including an 11-point scale in which participants are asked to rate their skin pain over the prior 24 hours, where 0 is no pain and 10 is the worst imaginable pain.

   Time frame: Baseline, Week 24

7. Absolute Change in ItchyQoL from Baseline at Week 24

   The ItchyQoL questionnaire is a PRO measure specifically designed to assess the impact of pruritus (itch) on an individual's quality of life. Both versions of ItchyQoL Frequency and Bother will be assessed in the study. The assessment consists of 22 items for Frequency and 15 items for Bother, covering 3 domains: symptoms, functioning, emotions. Each item utilises a 5-point response scale (1: never; 2: rarely; 3: sometimes; 4: often; 5: all of the time). A total score is calculated by summing individual item responses with higher scores indicating greater impact on health-related quality of life.

   Time frame: Baseline, Week 24

8. Percentage Change in Eczema Area and Severity Index (EASI) from Baseline at Week 24 in Participants with Atopic Dermatitis (AD)

   The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease.

   Time frame: Baseline, Week 24

9. Change from Baseline in Patient Global Impression of Severity (PGI-S) at Week 24

   PGI-S is a single-item assessment of perceived symptom or health status severity using a 5-point verbal rating scale ranging from 1 to 5 (no symptoms experienced, mild, moderate, severe, very severe).

   Time frame: Baseline, Week 24

10. Change from Baseline in PGI-S Itch at Week 24

    PGI-S is a single-item assessment of perceived symptom or health status severity using a 5-point verbal rating scale ranging from 1 to 5 (no symptoms experienced, mild, moderate, severe, very severe). Participants will be evaluated for PGI-S for itch for overall NE-related health status.

    Time frame: Baseline, Week 24

11. Patient Global Impression of Change (PGI-C) at Week 24

    The PGI-C is a single-item assessment of perceived change in a symptom or health status. Change is captured using a 7-point verbal rating scale (much worse, moderately worse, a little worse, no change, a little better, moderately better, and much better).

    Time frame: At Week 24

12. PGI-C Itch at Week 24

    The PGI-C is a single-item assessment of perceived change in a symptom or health status. Change is captured using a 7-point verbal rating scale (much worse, moderately worse, a little worse, no change, a little better, moderately better, and much better). Participants will be evaluated for PGI-C for itch for overall NE-related health status.

    Time frame: At Week 24

13. Clinical Global Impression of Change (CGI-C) at Week 24

    CGI-C is a single item assessment of change in participants' condition based on clinician assessment at a given timepoint. Change is captured using a 7-point verbal rating scale (much worse, moderately worse, a little worse, no change, a little improved, moderately improved, much improved).

    Time frame: At Week 24

14. Change from Baseline in Clinical Global Impression of Severity (CGI-S) at Week 24

    CGI-S is a single-item assessment of severity of the participants' condition based on clinician assessment at a given timepoint. Change is captured using a 4-point verbal rating scale (none, mild, moderate, severe).

    Time frame: Baseline, Week 24

15. Percentage of Participants with DLQI >=4 at Baseline Achieving DLQI >=4-point Improvement from Baseline at Week 24

    The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.

    Time frame: Baseline, Week 24

16. Percentage of Participants Achieving an IGA Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 48 Among those Participants who Achieved this Response at Week 24

    The IGA is an instrument used to globally rate the severity of a participants.

    Time frame: Baseline, Week 48

17. Percentage of Participants with Pruritus NRS >=4 at Baseline Achieving a >=4-point Improvement in Pruritus NRS Score from Baseline at Week 48, Among those Participants who Achieved this Response at Week 24

    The Pruritus NRS is an 11-point scale used by participants to rate their worst itch severity during the past 24 hours, with 0 indicating "No itch" and 10 indicating "Worst itch imaginable".

    Time frame: Baseline, Week 48

18. Percentage of Participants Achieving DLQI >=4-point Improvement from Baseline, from Week 24 up to Week 48, Among those Participants who Achieved this Response at Week 24

    The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.

    Time frame: Baseline, Week 24 up to Week 48

19. Absolute Change from Baseline in DLQI to Week 48

    The DLQI is a 10-item validated questionnaire completed by the participant used to assess the impact of skin disease on the participant's QoL during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 (not at all, a little, a lot, and very much), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.

    Time frame: Baseline up to Week 48

Individual participant data

Plan to share: No