A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT ID: NCT05999799
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
161 participants
INTERVENTIONAL
2023-11-16
2025-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GSK1070806 Dose 1
Participants will receive GSK1070806 dose 1.
GSK1070806
GSK1070806 will be administered.
GSK1070806 Dose 2
Participants will receive GSK1070806 dose 2.
GSK1070806
GSK1070806 will be administered.
GSK1070806 Dose 3
Participants will receive GSK1070806 dose 3.
GSK1070806
GSK1070806 will be administered.
GSK1070806 Dose 4
Participants will receive GSK1070806 dose 4.
GSK1070806
GSK1070806 will be administered.
Placebo
Participants will receive placebo.
Placebo
Placebo will be administered.
Interventions
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GSK1070806
GSK1070806 will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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, pre-existing or suspected parasitic infection within 6 months before the Screening visit.
* Symptomatic herpes zoster within 3 months prior to screening
* Uncontrolled hypertension.
* Current or chronic history of liver disease or known hepatic or biliary abnormalities.
* Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment.
* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Breast cancer within the past 10 years.
* History or presence of significant medical illness including but not limited to cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological, or psychiatric disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
* Previously treated with any oral Janus Kinase inhibitor (JAKi) or other kinase inhibitors, experimental or approved.
* Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma.
* Presence of Hepatitis B surface antibody (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
* Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
* Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
* Positive HIV antibody test.
* Evidence of active or latent TB as documented by medical history, examination, and TB testing with a positive QuantiFERON test at initial Screening visit.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
North Little Rock, Arkansas, United States
GSK Investigational Site
Canoga Park, California, United States
GSK Investigational Site
Fountain Valley, California, United States
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Northridge, California, United States
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Oceanside, California, United States
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Santa Monica, California, United States
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Homestead, Florida, United States
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Oakland Park, Florida, United States
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Fayetteville, Georgia, United States
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Thomasville, Georgia, United States
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Chicago, Illinois, United States
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Troy, Michigan, United States
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New York, New York, United States
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New York, New York, United States
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Dublin, Ohio, United States
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West Lake Hills, Texas, United States
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Buenos Aires, , Argentina
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Capital Federal, , Argentina
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Ciudad Autonoma de Bueno, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Kelowna, British Columbia, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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Markham, Ontario, Canada
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Québec, Quebec, Canada
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Beijing, , China
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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Shanghai, , China
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Shanghai, , China
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Yinchuan, , China
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Yiwu, , China
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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La Rochelle, , France
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Paris, , France
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Berlin, , Germany
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Hamburg, , Germany
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Münster, , Germany
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Athens, , Greece
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Bari, , Italy
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Bologna, , Italy
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Florence, , Italy
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Modena, , Italy
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Roma, , Italy
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Roma, , Italy
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Chiba, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Gunma, , Japan
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Hokkaido, , Japan
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Hokkaido, , Japan
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Kanagawa, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Saitama, , Japan
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Chihuahua City, , Mexico
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Durango, , Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Panama City, , Panama
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Chojnice, , Poland
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Elblag, , Poland
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Katowice, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Ansan, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Alicante, , Spain
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Córdoba, , Spain
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Granada, , Spain
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Madrid, , Spain
GSK Investigational Site
Vigo, , Spain
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Zaragoza, , Spain
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Pathum Thani, , Thailand
Countries
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Other Identifiers
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2023-505414-15-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
219538
Identifier Type: -
Identifier Source: org_study_id
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