Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis. (NCT06447506) | Clinical Trial Compass
TerminatedPhase 2
Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.
Stopped: Sponsor decision to early terminate the study following the termination of the parent study (NCT05999799), which met pre-defined futility criterion for efficacy. No safety concerns were identified.
United States, Argentina, Bulgaria79 participantsStarted 2024-06-05
Plain-language summary
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).
Who can participate
Age range
18 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:
* Participants must sign and date the consent document.
* Participants diagnosed with moderate to severe Atopic dermatitis (AtD) who have completed the qualifying Phase 2 parent study (NCT05999799) of GlaxoSmithKline (GSK's) AtD and, in their opinion, may benefit from GSK1070806.
* Be intentional and able to visit the doctor at the clinic by appointment and follow all procedures related to research studies and questionnaires (able to read and understand Patient-reported outcomes (PRO) questionnaires and be able to use electronic devices).
* The use of contraceptive methods for females should be consistent with local regulations on contraceptive methods of participants participating in clinical research programs.
* Female participants are eligible to participate in the research program if they are not pregnant or breastfeeding and meet one of the following conditions:
* It is Woman of nonchildbearing potential (WONCBP).
* It is Woman of childbearing potential (WOCBP) and uses a highly effective contraceptive method that has a failure rate less than (\<) 1 percent (%) during the trial dose period and for at least 16 weeks after the last dose of the research drug. We should assess the likelihood of contraceptive failure (e.g., non-cooperation, early contraception) associated with the first dose of the drug.
* WOCBP must obtain a negative result in a highly sensitive pregnancy test (by urine or serum test, as prescribed by local regulations) before receiving …
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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to Week 59
2
Number of Participants With TEAEs Leading to Permanent Discontinuation
Timeframe: Up to Week 59
3
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Up to Week 59
4
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESI)