Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

A Phase Ib, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Clinical Effect, Safety and Tolerability of a Single Intravenous Infusion of GSK1070806 in Moderate to Severe Atopic Dermatitis Patients

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

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic
• Intervention / Treatment: Drug: Placebo; Drug: GSK1070806

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • GSK Investigational Site
  • Ontario
    • London, Ontario, Canada, N6A 5R9
      • GSK Investigational Site
    • London, Ontario, Canada, N6H 5L5
      • GSK Investigational Site
• United States
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • GSK Investigational Site
  • Florida
    • Miami, Florida, United States, 33155
      • GSK Investigational Site
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
  • Michigan
    • Troy, Michigan, United States, 48084
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • GSK Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78218
      • GSK Investigational Site
    • Sugar Land, Texas, United States, 77479
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Biologic Naïve participants receiving GSK1070806	Drug: GSK1070806; GSK1070806 will be administered
Placebo Comparator: Group 1: Biologic Naïve participants receiving Placebo	Drug: Placebo; Placebo will be administered
Experimental: Group 2: Dupilumab inadequate responders receiving GSK1070806	Drug: GSK1070806; GSK1070806 will be administered
Placebo Comparator: Group 2: Dupilumab inadequate responders receiving Placebo	Drug: Placebo; Placebo will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 12 in Group 1	EASI is an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.	Baseline and at Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in EASI at Week 12 in Group 1	EASI is an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.	Baseline and at Week 12
Percentage of participants achieving >=50/75/90 percent reduction in EASI from Baseline at Week 12 in Group 1		Baseline to Week 12
Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1	IGA for AtD is a measure of overall disease severity at the time of assessment. It is measured on a 5 point scale where, 0=Clear; 1= Almost clear; 2=Mild disease; 3=Moderate disease; 4=Severe disease.	At Week 12
Percent Change from Baseline in EASI at Week 12 in Group 2	EASI is an investigator-assessed measure that is used to assess the extent (area) and severity of AtD. The range of the scale is 0-72, with a higher score indicating greater severity.	Baseline and at Week 12
Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) - Groups 1 and 2		Up to Week 24
Number of Participants with Clinically Significant findings in Vital signs, 12-lead Electrocardiogram (ECG) and Laboratory Parameters- Groups 1 and 2		Up to Week 24
Number of Participants With Positive Anti-drug Antibodies (ADA)- Groups 1 and 2		Up to Week 24

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2021
• Primary Completion (Actual): December 19, 2022
• Study Completion (Actual): March 13, 2023

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Eczema activity severity index; GSK1070806
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic
• Other Study ID Numbers: 215253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No