Phase
Condition
Rash
Allergy
Dermatitis, Atopic
Treatment
Placebo
GSK1070806
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
Moderate to severe AtD (confirmed by a dermatologist) according to the Hannifin andRajka criteria or Eichenfield revised criteria.
Onset of AtD symptoms occurring at least 6 months prior to Screening, with stabledisease for at least 1 month prior to Screening.
Eczema Activity Severity Index greater than or equal to (>=)16; Investigator GlobalAssessment 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) toout-patient treatment with at least one topical treatment (intermittent topicalcorticosteroid, topical calcineurin inhibitor), topical inhibitors orPhosphodiesterase 4 inhibitor (Crisaborole); b) or that topical treatments wereotherwise 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'sjudgement; b) or intolerant to dupilumab owing to adverse events.
Exclusion
Exclusion Criteria:
Other than AtD, the presence of a significant skin morbidity that will influence theInvestigator's ability to assess the severity of the disease (e.g. psoriasis,confirmed or suspected cutaneous T-cell lymphoma, autoimmune bullous disease, fixeddrug reaction and Stevens Johnson Syndrome).
Participants with any uncontrolled medical conditions, other than AtD, that in theopinion of the investigator puts the participant at unacceptable risk or will likelyinterfere with study assessments or data integrity. Other medical conditions shouldbe stable at the time of screening and be expected to remain stable for the durationof the study.
Treatment with biologic agents (investigational and marketed monoclonal antibodies)within 12 weeks or 5 pharmacokinetic half-lives (whichever is longer) prior dosingon 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.
Study Design
Connect with a study center
GSK Investigational Site
Edmonton, Alberta T6G 1C3
CanadaSite Not Available
GSK Investigational Site
Edmonton 5946768, Alberta 5883102 T6G 1C3
CanadaSite Not Available
GSK Investigational Site
London, Ontario N6A 5R9
CanadaSite Not Available
GSK Investigational Site
London 6058560, Ontario 6093943 N6A 5R9
CanadaSite Not Available
GSK Investigational Site
North Little Rock, Arkansas 72117
United StatesSite Not Available
GSK Investigational Site
North Little Rock 4124112, Arkansas 4099753 72117
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33155
United StatesSite Not Available
GSK Investigational Site
Tampa, Florida 33613
United StatesSite Not Available
GSK Investigational Site
Miami 4164138, Florida 4155751 33155
United StatesSite Not Available
GSK Investigational Site
Tampa 4174757, Florida 4155751 33613
United StatesSite Not Available
GSK Investigational Site
Indianapolis, Indiana 46256
United StatesSite Not Available
GSK Investigational Site
Troy, Michigan 48084
United StatesSite Not Available
GSK Investigational Site
Troy 5012639, Michigan 5001836 48084
United StatesSite Not Available
GSK Investigational Site
Oklahoma City, Oklahoma 73118
United StatesSite Not Available
GSK Investigational Site
Oklahoma City 4544349, Oklahoma 4544379 73118
United StatesSite Not Available
GSK Investigational Site
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
GSK Investigational Site
Philadelphia 4560349, Pennsylvania 6254927 19103
United StatesSite Not Available
GSK Investigational Site
San Antonio, Texas 78218
United StatesSite Not Available
GSK Investigational Site
Sugar Land, Texas 77479
United StatesSite Not Available
GSK Investigational Site
San Antonio 4726206, Texas 4736286 78218
United StatesSite Not Available
GSK Investigational Site
Sugar Land 4734825, Texas 4736286 77479
United StatesSite Not Available

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