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Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis
Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and at week 12
Summary
This trial is testing a new medication called GSK1070806 to see if it can help people with moderate to severe atopic dermatitis by reducing inflammation and itching.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and at week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and at week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1
Secondary study objectives
Change From Baseline in EASI Score at Week 12 in Group 1
Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1
Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1
+10 moreSide effects data
From 2023 Phase 1 trial • 34 Patients • NCT049754389%
COVID-19
4%
Neutrophil count abnormal
4%
Urticaria
4%
Suspected COVID-19
4%
Dermal cyst
4%
Face injury
4%
Dermatitis
4%
Diarrhoea
4%
White blood cell disorder
4%
Back pain
4%
Gastroenteritis
4%
Headache
4%
Hyponatraemia
4%
Hyperhidrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
GSK1070806
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 2: Dupilumab-IR with GSK1070806Experimental Treatment1 Intervention
Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.
Group II: Group 1: GSK1070806Experimental Treatment1 Intervention
Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.
Group III: Group 2: Dupilumab IR with PlaceboPlacebo Group1 Intervention
Participants received Placebo as intravenous infusion on Day 1.
Group IV: Group 1: PlaceboPlacebo Group1 Intervention
Participants received Placebo as intravenous infusion on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK1070806
2022
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,384,499 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,145,525 Total Patients Enrolled