A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participa… (NCT05999799) | Clinical Trial Compass
TerminatedPhase 2
A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis
Stopped: Sponsor decision to early terminate the study based on the pre-defined futility criterion for efficacy. No safety concerns were identified.
United States, Argentina, Bulgaria161 participantsStarted 2023-11-16
Plain-language summary
This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult participants 18 years to 75 years of age
* Participants with:
* AtD defined by the AAD Consensus Criteria.
* Diagnosis of AtD ≥1 year.
* An IGA score ≥3.
* AtD involvement of ≥10% body surface area (BSA).
* EASI score ≥16
* Baseline pruritus numerical rating scale average score for maximum intensity of at least 3.
* Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions:
* Participants who stopped treatment due to non-response, partial response, loss of efficacy.
* Participants who stopped treatment due to intolerance or AEs.
* Participant with a recent history less than or equal to (≤6) months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication.
* Participants for whom prescription topical medications are not tolerated.
* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical study
Exclusion Criteria:
* Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits.
* Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed)
* Known…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline (CFB) in Eczema Area and Severity Index (EASI) Score at Week 16