Targeting IL-13 in Bullous Pemphigoid: An Investigator-Initiated, Prospective, Multicenter, Proof-of-Concept, Open-Label Pilot Study of Lebrikizumab

Conditions

Bullous pemphigoid

Brief summary

Change in Bullous Pemphigoid Disease Area Index (BPDAI) score from Baseline to Week 48.

Detailed description

Change in Itch Numerical Rating Scale (NRS) from Baseline to Week 48., Change in Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) from Baseline to Week 24 and 48., Change in The Dermatology Life Quality Index (DLQI) from Baseline to Weeks 24 and 48., Proportion of participants achieving at least a 5% improvement from Baseline to Week 48 in psychological well-being, as measured by the World Health Organization–5 Well-Being Index (WHO-5)., Change from Baseline to Week 24 and 48 in Present State Examination as measured by the Cognitive Log (Cog–Log) scale., Change in Serum BP180 and BP230 at Baseline and Week 24 and 48, Immunoprecipitation in the dermal–epidermal junction of skin biopsies, Cumulative TCS use from Baseline through Week 48., Number of TCS–free days from Baseline through Week 48., Overall clinical response at Week 24 and 48 defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).*

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
Change in Bullous Pemphigoid Disease Area Index (BPDAI) score from Baseline to Week 48.	—

Secondary

Measure	Time frame
Change in Itch Numerical Rating Scale (NRS) from Baseline to Week 48., Change in Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) from Baseline to Week 24 and 48., Change in The Dermatology Life Quality Index (DLQI) from Baseline to Weeks 24 and 48., Proportion of participants achieving at least a 5% improvement from Baseline to Week 48 in psychological well-being, as measured by the World Health Organization–5 Well-Being Index (WHO-5)., Change from Baseline to Week 24 and 48 in Present State Examination as measured by the Cognitive Log (Cog–Log) scale., Change in Serum BP180 and BP230 at Baseline and Week 24 and 48, Immunoprecipitation in the dermal–epidermal junction of skin biopsies, Cumulative TCS use from Baseline through Week 48., Number of TCS–free days from Baseline through Week 48., Overall clinical response at Week 24 and 48 defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).*	—

Measure

Time frame

Change in Itch Numerical Rating Scale (NRS) from Baseline to Week 48., Change in Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) from Baseline to Week 24 and 48., Change in The Dermatology Life Quality Index (DLQI) from Baseline to Weeks 24 and 48., Proportion of participants achieving at least a 5% improvement from Baseline to Week 48 in psychological well-being, as measured by the World Health Organization–5 Well-Being Index (WHO-5)., Change from Baseline to Week 24 and 48 in Present State Examination as measured by the Cognitive Log (Cog–Log) scale., Change in Serum BP180 and BP230 at Baseline and Week 24 and 48, Immunoprecipitation in the dermal–epidermal junction of skin biopsies, Cumulative TCS use from Baseline through Week 48., Number of TCS–free days from Baseline through Week 48., Overall clinical response at Week 24 and 48 defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).*

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Outcome results

None listed