Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis
NCT ID: NCT04975438
Last Updated: 2025-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2021-11-18
2023-03-13
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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Group 1: GSK1070806
Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.
GSK1070806
GSK1070806 will be administered
Group 1: Placebo
Participants received Placebo as intravenous infusion on Day 1.
Placebo
Placebo will be administered
Group 2: Dupilumab-IR with GSK1070806
Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.
GSK1070806
GSK1070806 will be administered
Group 2: Dupilumab IR with Placebo
Participants received Placebo as intravenous infusion on Day 1.
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
* Onset of AtD symptoms occurring at least 6 months prior to Screening, with stable disease for at least 1 month prior to Screening.
* Eczema Activity Severity Index greater than or equal to (\>=)16; Investigator Global Assessment score \>=3.
* Group 1- Biologic Naïve: Topical First Line Treatment: Documented recent history (within 6 months before Screening) of: a) either an inadequate response (IR) to out-patient treatment with at least one topical treatment (intermittent topical corticosteroid, topical calcineurin inhibitor), topical inhibitors or Phosphodiesterase 4 inhibitor (Crisaborole); b) or that topical treatments were otherwise not recommended.
* Group 2- Dupilumab-Inadequate Responder: Documented history of an IR to dupilumab: a) either following at least 16 weeks of treatment according to the Investigator's judgement; b) or intolerant to dupilumab owing to adverse events.
Exclusion Criteria
* Participants with any uncontrolled medical conditions, other than AtD, that in the opinion of the investigator puts the participant at unacceptable risk or will likely interfere with study assessments or data integrity. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study.
* Treatment with biologic agents (investigational and marketed monoclonal antibodies) within 12 weeks or 5 pharmacokinetic half-lives (whichever is longer) prior dosing on Day 1.
* Treatment with Janus Activated Kinase inhibitors (e.g. baricitinib, upadacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to dosing on Day 1.
* Mycophenolate mofetil, azathioprine, methotrexate, or calcineurin inhibitors within 4 weeks of Screening.
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
North Little Rock, Arkansas, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Troy, Michigan, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Sugar Land, Texas, United States
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
London, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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215253
Identifier Type: -
Identifier Source: org_study_id
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