Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

Last updated: August 6, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

1

Condition

Rash

Allergy

Dermatitis, Atopic

Treatment

Placebo

GSK1070806

Clinical Study ID

NCT04975438
215253
  • Ages 18-75
  • All Genders

Study Summary

This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.

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

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
November 18, 2021
Estimated Completion Date:
March 13, 2023

Connect with a study center

  • GSK Investigational Site

    Edmonton, Alberta T6G 1C3
    Canada

    Site Not Available

  • GSK Investigational Site

    Edmonton 5946768, Alberta 5883102 T6G 1C3
    Canada

    Site Not Available

  • GSK Investigational Site

    London, Ontario N6A 5R9
    Canada

    Site Not Available

  • GSK Investigational Site

    London 6058560, Ontario 6093943 N6A 5R9
    Canada

    Site Not Available

  • GSK Investigational Site

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • GSK Investigational Site

    North Little Rock 4124112, Arkansas 4099753 72117
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33155
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa, Florida 33613
    United States

    Site Not Available

  • GSK Investigational Site

    Miami 4164138, Florida 4155751 33155
    United States

    Site Not Available

  • GSK Investigational Site

    Tampa 4174757, Florida 4155751 33613
    United States

    Site Not Available

  • GSK Investigational Site

    Indianapolis, Indiana 46256
    United States

    Site Not Available

  • GSK Investigational Site

    Troy, Michigan 48084
    United States

    Site Not Available

  • GSK Investigational Site

    Troy 5012639, Michigan 5001836 48084
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73118
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City 4544349, Oklahoma 4544379 73118
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19103
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia 4560349, Pennsylvania 6254927 19103
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78218
    United States

    Site Not Available

  • GSK Investigational Site

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio 4726206, Texas 4736286 78218
    United States

    Site Not Available

  • GSK Investigational Site

    Sugar Land 4734825, Texas 4736286 77479
    United States

    Site Not Available

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