Nummular Eczema
Conditions
Keywords
Nummular Eczema, Dermatitis, Skin Diseases, Lebrikizumab
Brief summary
The main aim of the study is to evaluate the efficacy, safety, and tolerability of lebrikizumab treatment in adult participants with Nummular Eczema (NE) who are not adequately controlled with Topical corticosteroids (TCS) or when this treatment is not medically advisable.
Interventions
DRUGLebrikizumab
Lebrikizumab SC injection.
OTHERPlacebo
Matching placebo SC injection.
Sponsors
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The study consists of a placebo-controlled period followed by a blinded extension period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants eligible for inclusion in this trial must fulfil all inclusion criteria per protocol, main criteria are listed below: * Ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and ability to provide written informed consent in accordance with institutional and regulatory guidelines. * Adult (aged 18 years or more at the time of Screening) diagnosed clinically with NE, as confirmed by the Investigator. * Presence of nummular eczema signs and/or symptoms for at least 6 months prior to Screening. * Investigator Global Assessment score \>=3 at both Screening and Baseline/Day 1 visits. * In the judgement of the Investigator, having inadequate response to TCS.
Exclusion criteria
Participants fulfilling any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Investigator Global Assessment (IGA) Score of 0 or 1 and a >=2-point Reduction from Baseline at Week 24 | Baseline, Week 24 | The IGA is an instrument used to globally rate the severity of a participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, 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". |
| Absolute Change from Baseline in Dermatology Quality of Life Index (DLQI) to Week 24 | Baseline up 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. |
| Percentage of Participants Achieving a 50 Percent (%) Reduction in Body Surface Area (BSA) from Baseline at Week 24 | Baseline, 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. |
| Absolute Change from Baseline in European Quality of Life Survey (EQ-5D-5L) at Week 24 | Baseline, 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). |
| Absolute Change from Baseline in Patient Global Assessment of Disease Status (PGADS) at Week 24 | Baseline, 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". |
| Absolute Change in Skin Pain NRS Score from Baseline at Week 24 | Baseline, 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. |
| Absolute Change in ItchyQoL from Baseline at Week 24 | Baseline, 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. |
| Percentage Change in Eczema Area and Severity Index (EASI) from Baseline at Week 24 in Participants with Atopic Dermatitis (AD) | Baseline, Week 24 | 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. |
| Change from Baseline in Patient Global Impression of Severity (PGI-S) at Week 24 | Baseline, 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). |
| Change from Baseline in PGI-S Itch at Week 24 | Baseline, 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. |
| Patient Global Impression of Change (PGI-C) at Week 24 | 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). |
| PGI-C Itch at Week 24 | 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. |
| Clinical Global Impression of Change (CGI-C) at Week 24 | 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). |
| Change from Baseline in Clinical Global Impression of Severity (CGI-S) at Week 24 | Baseline, 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). |
| Percentage of Participants with DLQI >=4 at Baseline Achieving DLQI >=4-point Improvement from Baseline at Week 24 | Baseline, 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. |
| 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 | Baseline, Week 48 | The IGA is an instrument used to globally rate the severity of a participants. |
| 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 | Baseline, Week 48 | 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". |
| 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 | Baseline, Week 24 up 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. |
| Absolute Change from Baseline in DLQI to Week 48 | Baseline up 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. |
Countries
Germany
Contacts
CONTACTEstrella Garcia
CONTACTNatalia Calderón
STUDY_DIRECTORStudy Director
Almirall, S.A.
Outcome results
None listed