Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.
NCT ID: NCT06447506
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
79 participants
INTERVENTIONAL
2024-06-05
2025-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GSK1070806 Dose 1
Participants will receive GSK1070806 Dose 1.
GSK1070806
Participants will receive GSK1070806.
GSK1070806 Dose 2
Participants will receive GSK1070806 Dose 2.
GSK1070806
Participants will receive GSK1070806.
GSK1070806 Dose 3
Participants will receive GSK1070806 Dose 3.
GSK1070806
Participants will receive GSK1070806.
GSK1070806 Dose 4
Participants will receive GSK1070806 Dose 4.
GSK1070806
Participants will receive GSK1070806.
Interventions
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GSK1070806
Participants will receive GSK1070806.
Eligibility Criteria
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Inclusion Criteria
* 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 the first dose of the research drug.
* If the urine test is positive, or the negative result cannot be confirmed (i.e., the result is unclear), a pregnancy test by serum test is required. In such cases, If the serum is tested, the test result is positive. Participants must be excluded from the research project.
* Additional requirements for testing pregnancy during and after exposure to the drug.
* The researcher is responsible for examining medical history, menstrual cycle history, and sexual activity in the near term. To reduce the risk of screening pregnant women who may not be detected at the beginning of pregnancy.
Exclusion Criteria
* Participants who, during GSK's qualifying Phase 2 (NCT05999799) AtD research project, developed adverse event (AE) or Serious adverse event (SAE) based on laboratory parameters, physical examination, vital signs, Electrocardiogram (ECG), medical history, etc. Medical history, in the opinion of the researchers, suggests that if Investigational medicinal product (IMP) is continued, it may cause unnecessary risk to the participants.
* Topical medications for AtD within 1 week prior to your appointment at Day 1, such as: Topical calcineurin inhibitors (TCI)/ Topical corticosteroids (TCS), Phosphodiesterase-4 (PDE-4) and Janus activation kinase inhibitors (JAKi) for external use.
* Topical corticosteroids (TCS) (such as hydrocortisone, betamethasone)
* Topical calcineurin inhibitors (TCI) (such as tacrolimus, pimecrolimus)
* Phosphodiesterase-4 (PDE4) inhibitor for external use (e.g., crisaborole)
* JAKi for external use (e.g. ruxolitinib)
* Medications for topical use, or other herbal/traditional medicines that may affect the AtD that the participants are in.
* Participant who received systemic therapy, which is considered contraindicated, including systemic therapy used as a rescue medication for AtD, from the screening for GSK's Phase 2 AtD 219538 research project until the LTE protocol began, were unable to participate in the research project.
* Chronic uncontrolled diseases that may require immediate oral corticosteroids, such as severe uncontrolled asthma (defined as having an Asthma control questionnaire (ACQ)-5 score greater than or equal to (\>=) 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Pompano Beach, Florida, United States
GSK Investigational Site
Fayetteville, Georgia, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Dublin, Ohio, United States
GSK Investigational Site
Santa Monica, Texas, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno, , Argentina
GSK Investigational Site
Córdoba, , Argentina
GSK Investigational Site
Rosario, , Argentina
GSK Investigational Site
Pleven, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Barrie, Ontario, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
Markham, Ontario, Canada
GSK Investigational Site
Chongqing, , China
GSK Investigational Site
Hangzhou, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
La Rochelle, , France
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Münster, , Germany
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Chiba, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Gunma, , Japan
GSK Investigational Site
Hokkaido, , Japan
GSK Investigational Site
Hokkaido, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Chihuahua City, , Mexico
GSK Investigational Site
Durango, , Mexico
GSK Investigational Site
Guadalajara, , Mexico
GSK Investigational Site
Panama City, , Panama
GSK Investigational Site
Elblag, , Poland
GSK Investigational Site
Katowice, , Poland
GSK Investigational Site
Szczecin, , Poland
GSK Investigational Site
Ansan, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Córdoba, , Spain
GSK Investigational Site
Granada, , Spain
GSK Investigational Site
Vigo, , Spain
Countries
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Other Identifiers
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220723
Identifier Type: -
Identifier Source: org_study_id
2023-508474-29-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
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