Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis. (AtDvance)

Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis.

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1055AAO
    • GSK Investigational Site
  • Ciudad Autonoma de Bueno, Argentina, C1056ABI
    • GSK Investigational Site
  • Córdoba, Argentina, X5000AAW
    • GSK Investigational Site
  • Rosario, Argentina, S2002
    • GSK Investigational Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • GSK Investigational Site
  • Sofia, Bulgaria, 1510
    • GSK Investigational Site
• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • GSK Investigational Site
    • London, Ontario, Canada, N6H 5L5
      • GSK Investigational Site
    • Markham, Ontario, Canada, L3P1X2
      • GSK Investigational Site
• China
  • Chongqing, China, 400016
    • GSK Investigational Site
  • Hangzhou, China, 310000
    • GSK Investigational Site
  • Shanghai, China, 200025
    • GSK Investigational Site
  • Shanghai, China
    • GSK Investigational Site
• Czechia
  • Prague, Czechia, 10034
    • GSK Investigational Site
  • Prague, Czechia
    • GSK Investigational Site
• France
  • La Rochelle, France, 17019
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10789
    • GSK Investigational Site
  • Münster, Germany, 48149
    • GSK Investigational Site
• Greece
  • Athens, Greece
    • GSK Investigational Site
• Japan
  • Chiba, Japan, 272-0033
    • GSK Investigational Site
  • Fukuoka, Japan, 812-8582
    • GSK Investigational Site
  • Fukuoka, Japan, 807-8556
    • GSK Investigational Site
  • Gunma, Japan, 370-0829
    • GSK Investigational Site
  • Hokkaido, Japan, 060-0033
    • GSK Investigational Site
  • Hokkaido, Japan, 080-0013
    • GSK Investigational Site
  • Kanagawa, Japan, 211-0063
    • GSK Investigational Site
  • Osaka, Japan, 583-8588
    • GSK Investigational Site
  • Osaka, Japan, 593-8324
    • GSK Investigational Site
  • Saitama, Japan, 343-8555
    • GSK Investigational Site
• Mexico
  • Chihuahua City, Mexico, 31000
    • GSK Investigational Site
  • Durango, Mexico, 34000
    • GSK Investigational Site
  • Guadalajara, Mexico, 44628
    • GSK Investigational Site
• Panama
  • Panama City, Panama, 7099
    • GSK Investigational Site
• Poland
  • Elblag, Poland, 82-300
    • GSK Investigational Site
  • Katowice, Poland, 40-600
    • GSK Investigational Site
  • Szczecin, Poland, 70-332
    • GSK Investigational Site
• South Korea
  • Ansan, South Korea, 15355
    • GSK Investigational Site
  • Seoul, South Korea, 04763
    • GSK Investigational Site
  • Seoul, South Korea, 03722
    • GSK Investigational Site
  • Seoul, South Korea, 100 799
    • GSK Investigational Site
  • Seoul, South Korea, 150-950
    • GSK Investigational Site
• Spain
  • Córdoba, Spain, 14004
    • GSK Investigational Site
  • Granada, Spain, 18016
    • GSK Investigational Site
  • Vigo, Spain, 36206
    • GSK Investigational Site
• United States
  • California
    • Fountain Valley, California, United States, 92708
      • GSK Investigational Site
  • Florida
    • Pompano Beach, Florida, United States, 33334
      • GSK Investigational Site
  • Georgia
    • Fayetteville, Georgia, United States, 30214
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10075
      • GSK Investigational Site
  • Ohio
    • Dublin, Ohio, United States, 43016
      • GSK Investigational Site
  • Texas
    • Santa Monica, Texas, United States, 90404
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must sign and date the consent document.
• Participants diagnosed with moderate to severe Atopic dermatitis (AtD) who have completed the qualifying Phase 2 parent study (NCT05999799) of GlaxoSmithKline (GSK's) AtD and, in their opinion, may benefit from GSK1070806.
• Be intentional and able to visit the doctor at the clinic by appointment and follow all procedures related to research studies and questionnaires (able to read and understand Patient-reported outcomes (PRO) questionnaires and be able to use electronic devices).
• The use of contraceptive methods for females should be consistent with local regulations on contraceptive methods of participants participating in clinical research programs.
• Female participants are eligible to participate in the research program if they are not pregnant or breastfeeding and meet one of the following conditions:
• It is Woman of nonchildbearing potential (WONCBP).
• It is Woman of childbearing potential (WOCBP) and uses a highly effective contraceptive method that has a failure rate less than (<) 1 percent (%) during the trial dose period and for at least 16 weeks after the last dose of the research drug. We should assess the likelihood of contraceptive failure (e.g., non-cooperation, early contraception) associated with the first dose of the drug.
• WOCBP must obtain a negative result in a highly sensitive pregnancy test (by urine or serum test, as prescribed by local regulations) before receiving the first dose of the research drug.
• If the urine test is positive, or the negative result cannot be confirmed (i.e., the result is unclear), a pregnancy test by serum test is required. In such cases, If the serum is tested, the test result is positive. Participants must be excluded from the research project.
• Additional requirements for testing pregnancy during and after exposure to the drug.
• The researcher is responsible for examining medical history, menstrual cycle history, and sexual activity in the near term. To reduce the risk of screening pregnant women who may not be detected at the beginning of pregnancy.

Exclusion Criteria:

• Permanent discontinuation of the study drug at any time during GSK's qualifying Phase 2 AtD (NCT05999799) or a medical condition that would hinder GSK's participation in the Phase 2 219538 (NCT05999799) AtD research project.
• Participants who, during GSK's qualifying Phase 2 (NCT05999799) AtD research project, developed adverse event (AE) or Serious adverse event (SAE) based on laboratory parameters, physical examination, vital signs, Electrocardiogram (ECG), medical history, etc. Medical history, in the opinion of the researchers, suggests that if Investigational medicinal product (IMP) is continued, it may cause unnecessary risk to the participants.
• Topical medications for AtD within 1 week prior to your appointment at Day 1, such as: Topical calcineurin inhibitors (TCI)/ Topical corticosteroids (TCS), Phosphodiesterase-4 (PDE-4) and Janus activation kinase inhibitors (JAKi) for external use.
• Topical corticosteroids (TCS) (such as hydrocortisone, betamethasone)
• Topical calcineurin inhibitors (TCI) (such as tacrolimus, pimecrolimus)
• Phosphodiesterase-4 (PDE4) inhibitor for external use (e.g., crisaborole)
• JAKi for external use (e.g. ruxolitinib)
• Medications for topical use, or other herbal/traditional medicines that may affect the AtD that the participants are in.
• Participant who received systemic therapy, which is considered contraindicated, including systemic therapy used as a rescue medication for AtD, from the screening for GSK's Phase 2 AtD 219538 research project until the LTE protocol began, were unable to participate in the research project.
• Chronic uncontrolled diseases that may require immediate oral corticosteroids, such as severe uncontrolled asthma (defined as having an Asthma control questionnaire (ACQ)-5 score greater than or equal to (>=) of 1.5 or a history of asthma exacerbations. >= 2 times within the last 12 months, requiring systemic corticosteroid [oral and/or intravenous medication] or requiring a >-24-hour hospital stay)
• Experience participating in previous/current clinical research projects.
• The participants have participated in any other clinical research studies. This is in addition to GSK's Phase 2 219538 (NCT05999799) research project.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo/Placebo; Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and continued on placebo subcutaneous (SC) injection in this long-term extension (LTE) study.	Drug: Placebo; Participants will receive Placebo
Experimental: Placebo/GSK1070806 Dose Level 4; Participants were previously treated with placebo in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.	Drug: GSK1070806; Participants will receive GSK1070806; Drug: Placebo; Participants will receive Placebo
Experimental: GSK1070806 Dose Level 1/GSK1070806 Dose Level 1; Participants were previously treated with GSK1070806 dose level 1 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 1 SC injection in this LTE study. Dose level 1 is the lowest dose level.	Drug: GSK1070806; Participants will receive GSK1070806
Experimental: GSK1070806 Dose Level 1/GSK1070806 Dose Level 4; Participants were previously treated with GSK1070806 dose level 1 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.	Drug: GSK1070806; Participants will receive GSK1070806
Experimental: GSK1070806 Dose Level 2/GSK1070806 Dose Level 2; Participants were previously treated with GSK1070806 dose level 2 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 2 SC injection in this LTE study. Dose level 2 is greater than dose level 1.	Drug: GSK1070806; Participants will receive GSK1070806
Experimental: GSK1070806 Dose Level 2/GSK1070806 Dose Level 4; Participants were previously treated with GSK1070806 dose level 2 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.	Drug: GSK1070806; Participants will receive GSK1070806
Experimental: GSK1070806 Dose Level 3/GSK1070806 Dose Level 3; Participants were previously treated with GSK1070806 dose level 3 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 3 SC injection in this LTE study. Dose level 3 is greater than dose level 2.	Drug: GSK1070806; Participants will receive GSK1070806
Experimental: GSK1070806 Dose Level 3/GSK1070806 Dose Level 4; Participants were previously treated with GSK1070806 dose level 3 in parent Study 219538 (NCT05999799) and received GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.	Drug: GSK1070806; Participants will receive GSK1070806
Experimental: GSK1070806 Dose Level 4/GSK1070806 Dose Level 4; Participants were previously treated with GSK1070806 dose level 4 in parent Study 219538 (NCT05999799) and maintained GSK1070806 dose level 4 SC injection in this LTE study. Dose level 4 is the highest dose level.	Drug: GSK1070806; Participants will receive GSK1070806

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Safety Analysis Set included all assigned participants who received at least 1 dose of study intervention in this LTE study. Participants were analyzed according to the intervention they actually received.	Up to Week 59
Number of Participants With TEAEs Leading to Permanent Discontinuation	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state. Number of participants with TEAE leading to permanent discontinuation of GSK1070806 were reported.	Up to Week 59
Number of Participants With Serious Adverse Events (SAEs)	An SAE is defined as any untoward medical occurrence that, at any dose: resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), is a suspected transmission of any infectious agent via an authorized medicinal product, and medically important were categorized as SAE.	Up to Week 59
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESI)	AESI for GSK1070806 include serious infections, opportunistic infections, serious hypersensitivity reactions, and injection site reactions (ISRs). A TEAE is an event that emerges during treatment, having been absent pre-treatment or worsens relative to the pre-treatment state.	Up to Week 59

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Achieved Investigators Global Assessment (IGA) Response (IGA Score of 0 or 1 and a Reduction of Greater Than or Equal to [>=]2 Points From Baseline) at Weeks 16, 32, and 48	IGA is a clinical tool to assess current state/severity of participant's atopic dermatitis (AtD). It is static 5-point morphological assessment of overall disease severity at time of assessment (TOA) determined by investigator, sub-investigator, or trained healthcare professional with required qualifications on scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, & 4=severe). Higher score=high severity of disease. Data for IGA 0 or 1 responders is presented in this outcome measure. IGA 0 or 1 responders: participants whose IGA score was 'Clear' (0) or 'Almost Clear' (1) & had reduction of >=2 points from Baseline at each visit. 2 participants had their assigned Dose Level (DL) modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.	Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
Number of Participants Who Achieved Reduction of Greater Than or Equal to (>=) 75 Percent (%) in Eczema Area and Severity Index (EASI) Score From Baseline at Weeks 16, 32 and 48	EASI scoring system is standardized clinical tool for assessment of extent(area) & severity of AtD.Severity of clinical signs of AtD(erythema, induration/papulation,excoriation & lichenification) scored separately for each of 4 body regions(head & neck, upper limbs, trunk & lower limbs) on 4-point scale: 0=absent;1=mild;2=moderate;3=severe. EASI area score was based upon % body surface area with AtD in body region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score was obtained by multiplying EASI area scores (0-6) with severity scores (0-3) of all 4 body regions; it ranges from 0 to 72, with higher scores= more severe or extensive condition. 2 participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.	Baseline (Day 1 from the parent study), Weeks 16, 32 and 48
Number of Participants Who Achieved Reduction of >=4 Points in Peak Pruritus Numerical Rating Scale (PP-NRS) Score From Baseline at Weeks 16, 32, and 48	PP-NRS is a patient reported measure of pruritus (itch) intensity assessing worst itch (in the past 24 hours). The values were evaluated using an 11-point scale (from 0 to 10), with 0 being no itch and 10 being the worst imaginable itch. Higher scores indicated worst itch. 2 participants had their assigned dose level (DL) modified during the study, hence were included in treatment arm of the highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Baseline was averaged from daily values from Day -7 to Day -1 of the parent study 219538 (NCT05999799).	Baseline (Day -7 to Day -1 from the parent study), Weeks 16, 32, and 48
Number of Participants Who Maintained IGA Response (IGA Score of 0 or 1 and a Reduction of >=2 Points From Baseline) at Weeks 16, 32, and 48	IGA is clinical tool to assess current state/severity of a participant's AtD. It measures overall disease severity at TOA(determined by investigator) using static 5-point scale(0-4): 0=clear,1=almost clear,2=mild,3=moderate,4-=severe. Higher scores indicate greater severity. IGA 0/1 responders are participants whose IGA score was 'Clear'(0) or 'Almost Clear'(1) & had reduction of >=2 points from Baseline at each visit. 2 participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', and 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Response is considered maintained if achieved at Week 16 and sustained at later LTE timepoints; earliest maintenance timepoint was Week 32.	Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
Number of Participants Who Maintained Response of Reduction of >= 75% in EASI Score From Baseline at Weeks 16, 32, and 48	EASI: standardized clinical tool to assess extent(area) & severity of AtD.Severity of signs (erythema,induration/papulation,excoriation & lichenification) scored on 0-3 scale (0=absent;1=mild;2=moderate;3=severe) across 4 regions: head&neck, upper limbs, trunk, & lower limbs. Area score reflects % body surface area with AtD per region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score=area scores(0-6) multiplied by severity scores(0-3) across regions; range: 0-72, higher scores=more severe/extensive disease. 2 participants had their assigned DL modified during study, hence included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', & 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4. Response is considered maintained if achieved at Week 16 and sustained at later LTE timepoints; earliest maintenance timepoint was Week 32.	Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
Percent Change From Baseline (CFB) in EASI Score at Weeks 16, 32, and 48	EASI: standardized clinical tool to assess extent(area) & severity of AtD.Severity of signs (erythema,induration/papulation,excoriation & lichenification) scored on 0-3 scale (0=absent;1=mild;2=moderate;3=severe) across 4 regions: head&neck, upper limbs, trunk, & lower limbs. Area score reflects % body surface area with AtD per region:0=0%,1=1-9%;2=10-29%;3=30-49%;4=50-69%;5=70-89%;6=90-100%. Final EASI score=area scores(0-6) multiplied by severity scores(0-3) across regions; range: 0-72, higher scores=more severe/extensive disease. CFB=post-dose visit value minus Baseline value (BV). Percent CFB=CFB value divided by BV & multiplied by 100. Two participants had their assigned DL modified during study, hence were included in treatment arm of highest dose they received (1 participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4', & 1 participant moved from "GSK1070806 DL 2/GSK1070806 DL 2" to "GSK1070806 DL 2/GSK1070806 DL 4.	Baseline (Day 1 from the parent study), Weeks 16, 32, and 48

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): July 29, 2025
• Study Completion (Actual): July 29, 2025

Study Registration Dates

• First Submitted: June 3, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Eczema; Dermatitis; Atopic dermatits; GSK1070806; Immune system Disease
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Dermatitis; Eczema; Immune System Diseases; GSK1070806
• Other Study ID Numbers: 220723; 2023-508474-29-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 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
• product manufactured in and exported from the U.S.: Yes