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GSK1070806 for Eczema (AtDvance Trial)
Phase 2
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
Must not have
Use of systemic therapy considered contraindicated for AtD.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16, 32, 48 and up to week 280 (eos)
Awards & highlights
Summary
This trial aims to assess how safe and effective GSK1070806 is in treating moderate to severe atopic dermatitis in participants who have already completed a previous study for the same condition.
Who is the study for?
This trial is for individuals with moderate to severe atopic dermatitis who completed the Phase 2 study (NCT05999799) and may benefit from further treatment. Participants must be able to attend clinic visits, use electronic devices for questionnaires, and women of childbearing potential must follow strict contraceptive guidelines and have negative pregnancy tests.
What is being tested?
The long-term safety and effectiveness of GSK1070806 are being tested in patients with atopic dermatitis who previously participated in a related Phase 2b study. The goal is to see how well this drug works over an extended period.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse events that arise during the course of treatment with GSK1070806, especially those that led to discontinuation in earlier phases.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
Systemic therapy is not suitable for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16, 32, 48 and up to week 280 (eos)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16, 32, 48 and up to week 280 (eos)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with AE leading to discontinuation of GSK1070806
Number of participants with Adverse event (AE)
Number of participants with Serious adverse event (SAE)
+1 moreSecondary study objectives
Number of Participants Achieving Investigators Global Assessment (IGA) score of 0 or 1 at 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)
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)
+3 moreSide effects data
From 2023 Phase 1 trial • 34 Patients • NCT049754389%
COVID-19
4%
Dermal cyst
4%
Back pain
4%
Dermatitis
4%
Diarrhoea
4%
Face injury
4%
Hyperhidrosis
4%
Gastroenteritis
4%
Urticaria
4%
White blood cell disorder
4%
Headache
4%
Neutrophil count abnormal
4%
Suspected COVID-19
4%
Hyponatraemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
GSK1070806
Trial Design
4Treatment groups
Experimental Treatment
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.
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
4,788 Previous Clinical Trials
8,176,649 Total Patients Enrolled
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