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Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GSK1070806
Placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Eczema activity severity index, GSK1070806

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Group 1: Biologic Naïve participants receiving GSK1070806

Group 1: Biologic Naïve participants receiving Placebo

Group 2: Dupilumab inadequate responders receiving GSK1070806

Group 2: Dupilumab inadequate responders receiving Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Percentage of participants achieving >=50/75/90 percent reduction in EASI from Baseline at Week 12 in Group 1
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.
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.
Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) - Groups 1 and 2
Number of Participants with Clinically Significant findings in Vital signs, 12-lead Electrocardiogram (ECG) and Laboratory Parameters- Groups 1 and 2
Number of Participants With Positive Anti-drug Antibodies (ADA)- Groups 1 and 2

Full Information

First Posted
July 14, 2021
Last Updated
August 18, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT04975438
Brief Title
Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Eczema activity severity index, GSK1070806

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
This is a double-blind study
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Biologic Naïve participants receiving GSK1070806
Arm Type
Experimental
Arm Title
Group 1: Biologic Naïve participants receiving Placebo
Arm Type
Placebo Comparator
Arm Title
Group 2: Dupilumab inadequate responders receiving GSK1070806
Arm Type
Experimental
Arm Title
Group 2: Dupilumab inadequate responders receiving Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GSK1070806
Intervention Description
GSK1070806 will be administered
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered
Primary Outcome Measure Information:
Title
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 12 in Group 1
Description
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.
Time Frame
Baseline and at Week 12
Secondary Outcome Measure Information:
Title
Change from Baseline in EASI at Week 12 in Group 1
Description
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.
Time Frame
Baseline and at Week 12
Title
Percentage of participants achieving >=50/75/90 percent reduction in EASI from Baseline at Week 12 in Group 1
Time Frame
Baseline to Week 12
Title
Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1
Description
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.
Time Frame
At Week 12
Title
Percent Change from Baseline in EASI at Week 12 in Group 2
Description
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.
Time Frame
Baseline and at Week 12
Title
Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) - Groups 1 and 2
Time Frame
Up to Week 24
Title
Number of Participants with Clinically Significant findings in Vital signs, 12-lead Electrocardiogram (ECG) and Laboratory Parameters- Groups 1 and 2
Time Frame
Up to Week 24
Title
Number of Participants With Positive Anti-drug Antibodies (ADA)- Groups 1 and 2
Time Frame
Up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
GSK Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73118
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
GSK Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
GSK Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R9
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 5L5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://clinicalstudydatarequest.com

Learn more about this trial

Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

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