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Terminated
NCT06447506
Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.
Conditions: Dermatitis, Atopic
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 79
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site Fountain Valley California
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).
Eligibility Criteria
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 (\=) of 1.5 or a history of asthma exacerbations. \>= 2 times within the last 12 months, requiring systemic corticosteroid \[oral and/or intravenous medication\] or requiring a \>-24-hour hospital stay)
* Experience participating in previous/current clinical research projects.
* The participants have participated in any other clinical research studies. This is in addition to GSK's Phase 2 219538 (NCT05999799) research project.
Source: ClinicalTrials.gov (NCT06447506). StuddyBuddy aggregates publicly available trial information.