Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04975438
• Other study ID #: 215253
• Status: Completed
• Phase: Phase 1
• Start date: November 18, 2021
• Est. completion date: March 13, 2023

Study information

• Verified date: August 2023
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 13, 2023
• Est. primary completion date: December 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• GSK1070806
GSK1070806 will be administered
• Placebo
Placebo will be administered

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	London	Ontario
Canada	GSK Investigational Site	London	Ontario
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	North Little Rock	Arkansas
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Sugar Land	Texas
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage of participants achieving >=50/75/90 percent reduction in EASI from Baseline at Week 12 in Group 1		Baseline to Week 12
Secondary	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
Secondary	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
Secondary	Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) - Groups 1 and 2		Up to Week 24
Secondary	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
Secondary	Number of Participants With Positive Anti-drug Antibodies (ADA)- Groups 1 and 2		Up to Week 24