Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis (NCT04975438) | Clinical Trial Compass
CompletedPhase 1
Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis
United States34 participantsStarted 2021-11-18
Plain-language summary
This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria:
* Moderate to severe AtD (confirmed by a dermatologist) according to the Hannifin and Rajka criteria or Eichenfield revised 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:
* Other than AtD, the presence of a significant skin morbidity that will influence the Investigator's ability to assess the severity of the disease (e.g. psoriasis, confirmed or suspected cutaneous T-cell lymphoma, autoimmune bullous disease, fixed drug reaction and Stevens Johnson Syndrome).
* Participants with any uncontrolled medical conditions, other than AtD, that in the opinion of the investigator puts the participan…
What they're measuring
1
Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1