A Phase IV, non-randomized, open-label multinational trial to assess the mechanism of action for Lebrikizumab in moderate-to-severe atopic dermatitis

Conditions

Moderate-to-severe atopic dermatitis

Brief summary

Degree of normalization of transcriptomic and epigenetic profile in skin biopsies from baseline over time, measuring molecular changes after treatment with lebrikizumab

Detailed description

1. Molecular (transcriptomic/epigenetic) response to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60., 2. Molecular (transcriptomic/epigenetic) change to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60., 3. Molecular (transcriptomic/epigenetic) response after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm., 4. Molecular (transcriptomic/epigenetic) changes after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm., 5. Improvement in skin barrier function as assessed by serial TEWL measurements in lesional skin from baseline to week 60 in all subjects., 6. Correlation between clinical response (EASI/IGA and Pruitis NRS) with molecular (transcriptomic/epigenetic) at weeks 2, 24, 36, and 60.

Related papers

No related papers found yet.

Interventions

DRUGEbglyss 250 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Degree of normalization of transcriptomic and epigenetic profile in skin biopsies from baseline over time, measuring molecular changes after treatment with lebrikizumab	—

Secondary

Measure	Time frame
1. Molecular (transcriptomic/epigenetic) response to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60., 2. Molecular (transcriptomic/epigenetic) change to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60., 3. Molecular (transcriptomic/epigenetic) response after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm., 4. Molecular (transcriptomic/epigenetic) changes after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm., 5. Improvement in skin barrier function as assessed by serial TEWL measurements in lesional skin from baseline to week 60 in all subjects., 6. Correlation between clinical response (EASI/IGA and Pruitis NRS) with molecular (transcriptomic/epigenetic) at weeks 2, 24, 36, and 60.	—

Measure

Time frame

1. Molecular (transcriptomic/epigenetic) response to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60., 2. Molecular (transcriptomic/epigenetic) change to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60., 3. Molecular (transcriptomic/epigenetic) response after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm., 4. Molecular (transcriptomic/epigenetic) changes after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm., 5. Improvement in skin barrier function as assessed by serial TEWL measurements in lesional skin from baseline to week 60 in all subjects., 6. Correlation between clinical response (EASI/IGA and Pruitis NRS) with molecular (transcriptomic/epigenetic) at weeks 2, 24, 36, and 60.

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Countries

Germany

Outcome results

None listed