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Monoclonal Antibodies
GSK1070806 for Atopic Dermatitis (AtDventure Trial)
Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Baseline pruritus numerical rating scale average score for maximum intensity of at least 3.
AtD involvement of ≥10% body surface area (BSA).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 28
Summary
This trial studies an Atopic Dermatitis drug for safety, effectiveness, and how it works in the body.
Who is the study for?
Adults aged 18-75 with moderate to severe Atopic Dermatitis (AD), covering at least 10% of their body, who have tried and stopped other AD treatments due to intolerance, ineffectiveness, or access issues. They must have had AD for over a year and currently experience significant itching.
What is being tested?
The trial is testing GSK1070806's safety and effectiveness compared to a placebo in adults with moderate to severe AD. It's designed as a parallel group study where participants are randomly assigned to receive either the drug or placebo.
What are the potential side effects?
Specific side effects of GSK1070806 aren't listed here, but common ones for new treatments in AD may include skin reactions at the treatment site, infections, headaches, nausea, and potential systemic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience itching at a severity of at least 3 out of 10.
Select...
My skin condition affects 10% or more of my body.
Select...
I am between 18 and 75 years old.
Select...
I stopped my treatment because it wasn't working well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 28
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 the Eczema Area and Severity Index (EASI) at Week 16
Secondary study objectives
Change from Baseline in PRO Measure of Brief Fatigue Inventory (BFI) - Item 3 at Week 16
Change from Baseline in PRO Measure of Dermatology Life Quality Index (DLQI) at Week 16
Change from Baseline in PRO Measure of Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue at Week 16
+16 moreSide effects data
From 2023 Phase 1 trial • 34 Patients • NCT049754389%
COVID-19
4%
Dermal cyst
4%
Face injury
4%
Back pain
4%
Gastroenteritis
4%
Urticaria
4%
White blood cell disorder
4%
Headache
4%
Neutrophil count abnormal
4%
Suspected COVID-19
4%
Hyponatraemia
4%
Dermatitis
4%
Diarrhoea
4%
Hyperhidrosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
GSK1070806
Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: GSK1070806 Dose 4Experimental Treatment1 Intervention
Participants will receive GSK1070806 dose 4.
Group II: GSK1070806 Dose 3Experimental Treatment1 Intervention
Participants will receive GSK1070806 dose 3.
Group III: GSK1070806 Dose 2Experimental Treatment1 Intervention
Participants will receive GSK1070806 dose 2.
Group IV: GSK1070806 Dose 1Experimental Treatment1 Intervention
Participants will receive GSK1070806 dose 1.
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
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
4,805 Previous Clinical Trials
8,379,331 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,699 Total Patients Enrolled
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