Trial Outcomes & Findings for Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis. (NCT NCT06447506)

This is long-term extension (LTE) study of parent study 219538 (NCT05999799). A total of 79 participants were enrolled in this study. This study was terminated after the parent study 219538 (NCT05999799) met pre-defined futility criteria.

Dosing information (dose levels and frequency) has not been disclosed because it is considered commercially confidential information (CCI) for studies 219538 (NCT05999799) and 220723 (NCT06447506). Dose levels are presented as Dose level 1 (lowest dose level) to Dose level 4 (highest dose level) along with directionality of the dosage within each arm/group.

Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Safety Analysis Set included all assigned participants who received at least 1 dose of study intervention in this LTE study. Participants were analyzed according to the intervention they actually received.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Number of participants with TEAE leading to permanent discontinuation of GSK1070806 were reported.

An SAE is defined as any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), is a suspected transmission of any infectious agent via an authorized medicinal product, and medically important were categorized as SAE.

AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions, and injection site reactions (ISRs). A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state.

IGA is a clinical tool to assess current state/severity of participant's atopic dermatitis (AtD). It is static 5-point morphological assessment of overall disease severity at time of assessment (TOA) determined by investigator, sub-investigator, or trained healthcare professional with required qualifications on scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, \& 4=severe). Higher score=high severity of disease. Data for IGA 0 or 1 responders is presented in this outcome measure. IGA 0 or 1 responders: participants whose IGA score was 'Clear' (0) or 'Almost Clear' (1) \& had reduction of \>=2 points from Baseline at each visit. 2 participants had their assigned Dose Level (DL) modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.

EASI scoring system is standardized clinical tool for assessment of extent(area) \& severity of AtD.Severity of clinical signs of AtD(erythema, induration/papulation,excoriation \& lichenification) scored separately for each of 4 body regions(head \& neck, upper limbs, trunk \& lower limbs) on 4-point scale: 0=absent;1=mild;2=moderate;3=severe. EASI area score was based upon % body surface area with AtD in body region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score was obtained by multiplying EASI area scores (0-6) with severity scores (0-3) of all 4 body regions; it ranges from 0 to 72, with higher scores= more severe or extensive condition. 2 participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.

PP-NRS is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values were evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch. Higher scores indicated worst itch. 2 participants had their assigned dose level (DL) modified during the study, hence were included in treatment arm of the highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Baseline was averaged from daily values from Day -7 to Day -1 of the parent study 219538 (NCT05999799).

IGA is clinical tool to assess current state/severity of a participant's AtD. It measures overall disease severity at TOA(determined by investigator) using static 5-point scale(0-4): 0=clear,1=almost clear,2=mild,3=moderate,4-=severe. Higher scores indicate greater severity. IGA 0/1 responders are participants whose IGA score was 'Clear'(0) or 'Almost Clear'(1) \& had reduction of \>=2 points from Baseline at each visit. 2 participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Response is considered maintained if achieved at Week 16 and sustained at later LTE timepoints; earliest maintenance timepoint was Week 32.

EASI: standardized clinical tool to assess extent(area) \& severity of AtD.Severity of signs (erythema,induration/papulation,excoriation \& lichenification) scored on 0-3 scale (0=absent;1=mild;2=moderate;3=severe) across 4 regions: head\&neck, upper limbs, trunk, \& lower limbs. Area score reflects % body surface area with AtD per region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score=area scores(0-6) multiplied by severity scores(0-3) across regions; range: 0-72, higher scores=more severe/extensive disease. 2 participants had their assigned DL modified during study, hence included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', \& 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Response is considered maintained if achieved at Week 16 and sustained at later LTE timepoints; earliest maintenance timepoint was Week 32.

EASI: standardized clinical tool to assess extent(area) \& severity of AtD.Severity of signs (erythema,induration/papulation,excoriation \& lichenification) scored on 0-3 scale (0=absent;1=mild;2=moderate;3=severe) across 4 regions: head\&neck, upper limbs, trunk, \& lower limbs. Area score reflects % body surface area with AtD per region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score=area scores(0-6) multiplied by severity scores(0-3) across regions; range: 0-72, higher scores=more severe/extensive disease. CFB=post-dose visit value minus Baseline value (BV). Percent CFB=CFB value divided by BV \& multiplied by 100. Two participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', \& 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.