Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

NCT04975438 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 215253
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 11

Brief Summary

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

Conditions

Dermatitis, Atopic

Keywords

Eczema activity severity index; GSK1070806

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1

  EASI scoring system is standardized clinical tool for assessment of extent (area) and severity of atopic dermatitis (AD). Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % body surface area with AD in body region: 0 (0%), 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100% The final EASI score was obtained by weight-averaging these 4 scores and scores ranged from 0 to 72, with higher scores= more severe or extensive condition. Posterior Median presented from Bayesian analysis under the hypothetical strategy. The percent change from baseline in the EASI score at week 12 in group 1 is reported here. Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'.

  Baseline (Day 1) and at Week 12

Secondary Outcomes (13)

• Change From Baseline in EASI Score at Week 12 in Group 1

  Baseline (Day 1) and at Week 12

• Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1

  At Week 12

• Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1

  At Week 12

• Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1

  At Week 12

• Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1

  At Week 12

Study Arms (4)

Group 1: GSK1070806

EXPERIMENTAL

Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.

Drug: GSK1070806

Group 1: Placebo

PLACEBO COMPARATOR

Participants received Placebo as intravenous infusion on Day 1.

Drug: Placebo

Group 2: Dupilumab-IR with GSK1070806

EXPERIMENTAL

Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.

Drug: GSK1070806

Group 2: Dupilumab IR with Placebo

PLACEBO COMPARATOR

Participants received Placebo as intravenous infusion on Day 1.

Drug: Placebo

Interventions

GSK1070806 DRUG

GSK1070806 will be administered

Group 1: GSK1070806; Group 2: Dupilumab-IR with GSK1070806

Placebo DRUG

Placebo will be administered

Group 1: Placebo; Group 2: Dupilumab IR with Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

North Little Rock, Arkansas, 72117, United States

Location

GSK Investigational Site

Miami, Florida, 33155, United States

Location

GSK Investigational Site

Tampa, Florida, 33613, United States

Location

GSK Investigational Site

Troy, Michigan, 48084, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73118, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19103, United States

Location

GSK Investigational Site

San Antonio, Texas, 78218, United States

Location

GSK Investigational Site

Sugar Land, Texas, 77479, United States

Location

GSK Investigational Site

Edmonton, Alberta, T6G 1C3, Canada

Location

GSK Investigational Site

London, Ontario, N6A 5R9, Canada

Location

GSK Investigational Site

London, Ontario, N6H 5L5, Canada

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

GSK1070806

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: November 18, 2021
• Primary Completion: December 19, 2022
• Study Completion: March 13, 2023
• Last Updated: August 28, 2025
• Results First Posted: July 23, 2024

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CA (3); US (8)