The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
79
Participants will receive GSK1070806.
Number of participants with Adverse event (AE)
An AE is any untoward medical occurrence in participant, temporally associated with use of study intervention, whether or not considered related to medicinal product.
Time frame: Up to Week 280 (End of study [EoS])
Number of participants with AE leading to discontinuation of GSK1070806
An AE leading to discontinuation of GSK1070806 will be reported.
Time frame: Up to Week 280 (EoS)
Number of participants with Serious adverse event (SAE)
Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, medically important were categorized as SAE.
Time frame: Up to Week 280 (EoS)
Number of participants with adverse event of special interest (AESI)
AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions and injection site reactions (ISRs).
Time frame: Up to Week 280 (EoS)
Number of Participants Achieving Investigators Global Assessment (IGA) score of 0 or 1 at Week 16, 32, 48 and up to Week 280 (EoS)
IGA for Atopic dermatitis (AtD) is a measure of overall disease severity at the time of assessment on a 5-point scale by the investigator. Where 0-clear, 1-almost clear, 2-mild disease, 3-moderate disease, and 4- severe disease. Higher score indicates severity of disease. A participant with an IGA score of 0 or 1 from baseline will be reported.
Time frame: Week 16, 32, 48 and up to Week 280 (EoS)
Number of participants Achieving Eczema Area and Severity Index (EASI) reduction of greater than or equal to (>=) 75 percent (%) at Week 16, 32, 48 and up to Week 280 (EoS)
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GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Pompano Beach, Florida, United States
GSK Investigational Site
Fayetteville, Georgia, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Dublin, Ohio, United States
GSK Investigational Site
Santa Monica, Texas, United States
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, Argentina
GSK Investigational Site
Córdoba, Argentina
...and 41 more locations
The occurrence of \>=75% reduction from baseline achieving EASI 75 score at Week 16, 32, 48 and up to Week 208 (EoS) will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
Time frame: Week 16, 32, 48 and up to Week 280 (EoS)
Number of participants with decreased Peak Pruritus Numerical Rating Scale (PP-NRS) by >=4 points at Week 16, 32, 48 and up to Week 280 (EoS)
Peak pruritus numerical rating scale (PP-NRS) is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values will be evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch.
Time frame: Week 16, 32, 48 and up to Week 280 (EoS)
Percentage of participants Achieving maintained response for IGA of 0 to 1 at Week 16, 32, 48 and up to Week 280 (EoS)
IGA for AtD is a measure of overall disease severity at the time of assessment on a 5-point scale by the investigator. Where 0-clear, 1-almost clear, 2-mild disease, 3-moderate disease, and 4- severe disease. Higher score indicates severity of disease.
Time frame: Week 16, 32, 48 and up to Week 280 (EoS)
Percentage of participants Achieving maintained response for EASI reduction to >= 75% at Week 16, 32, 48 and up to Week 280 (EoS)
The occurrence of \>=75% reduction from baseline achieving EASI 75 score at Week 16, 32, 48 and up to Week 208 (EoS) will be reported. EASI is an internationally used classification for AtD severity and an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
Time frame: Week 16, 32, 48 and up to Week 280 (EoS)
Percentage change from Baseline in EASI at week 16, 32, 48 and up to Week 280 (EoS)
EASI is an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.
Time frame: Week 16, 32, 48 and up to Week 280 (EoS)