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A Study of Lebrikizumab in Adults With Nummular Eczema

ConditionNummular Eczema
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlmirall, S.A.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Documented history or current presence of moderate-to-severe AD at the Screening visit, or documented diagnosis of moderate-to-severe AD from Screening to Baseline/Day 1 visit (ie, EASI >=16).

Presence of any skin disease, other than NE or mild AD, that could interfere with assessment of the study outcomes, including but not limited to psoriasis and other forms of eczema (dyshidrotic eczema, stasis dermatitis, asteatotic eczema, and neurodermatitis).

Presence of any skin manifestations suggestive of psoriasis including but not limited to nail pitting, scalp, palms, soles, or skin folds involvement, as well as personal or family history of psoriasis or psoriatic arthritis.

Prior treatment at any time with lebrikizumab, dupilumab, tralokinumab, or oral Janus kinase inhibitor.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lebrikizumab

    Drug

    Lebrikizumab SC injection.

  • Placebo

    Other intervention

    Matching placebo SC injection.

Treatment groups

270 Participants
are divided into 4 treatment groups
Group A: Placebo-controlled Period: LebrikizumabExperimental treatment 1 intervention
Group B: Placebo-controlled Period: PlaceboPlacebo comparator 1 intervention
Group C: Blinded Extension Period: LebrikizumabExperimental treatment 1 intervention
Group D: Blinded Extension Period: Lebrikizumab + PlaceboExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Almirall, S.A.

Lead sponsor

Source ClinicalTrials.gov
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