Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atop... | NCT06447506 | Trialant
NCT06447506
Sponsor
GlaxoSmithKline
Status
Terminated
Last Update Posted
Jun 16, 2026Actual
Enrollment
79Actual
Phase
Phase 2
Conditions
Dermatitis, Atopic
Interventions
GSK1070806
Placebo
Countries
United States
Argentina
Bulgaria
Canada
China
Czechia
France
Germany
Greece
Japan
Mexico
Panama
Poland
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT06447506
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
220723
Secondary IDs
ID
Type
Description
Link
2023-508474-29-00
Registry Identifier
CTIS
Brief Title
Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.
Official Title
Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis.
Acronym
AtDvance
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision to early terminate the study following the termination of the parent study (NCT05999799), which met pre-defined futility criterion for efficacy. No safety concerns were identified.
Expanded Access Info
No
Start Date
Jun 5, 2024Actual
Primary Completion Date
Jul 29, 2025Actual
Completion Date
Jul 29, 2025Actual
First Submitted Date
Jun 3, 2024
First Submission Date that Met QC Criteria
Jun 3, 2024
First Posted Date
Jun 7, 2024Actual
Results Waived
Not provided
Results First Submitted Date
Apr 7, 2026
Results First Submitted that Met QC Criteria
May 20, 2026
Results First Posted Date
Jun 16, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 20, 2026
Last Update Posted Date
Jun 16, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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).
Detailed Description
Not provided
Conditions Module
Conditions
Dermatitis, Atopic
Keywords
Atopic dermatits
Dermatitis
Eczema
GSK1070806
Safety
Efficacy
Immune system Disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
79Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo/Placebo
Placebo Comparator
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
Placebo/GSK1070806 Dose Level 4
Experimental
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
Drug: Placebo
GSK1070806 Dose Level 1/GSK1070806 Dose Level 1
Experimental
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
GSK1070806 Dose Level 1/GSK1070806 Dose Level 4
Experimental
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
GSK1070806 Dose Level 2/GSK1070806 Dose Level 2
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK1070806
Drug
Participants will receive GSK1070806
GSK1070806 Dose Level 1/GSK1070806 Dose Level 1
GSK1070806 Dose Level 1/GSK1070806 Dose Level 4
Outcomes Module
Primary Outcomes
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.
Secondary Outcomes
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Fountain Valley
California
92708
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
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
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
Dosing information (dose levels and frequency) has not been disclosed because it is considered commercially confidential information (CCI) for studies 219538 (NCT05999799) and 220723 (NCT06447506). Dose levels are presented as Dose level 1 (lowest dose level) to Dose level 4 (highest dose level) along with directionality of the dosage within each arm/group.
Recruitment Details
This is long-term extension (LTE) study of parent study 219538 (NCT05999799). A total of 79 participants were enrolled in this study. This study was terminated after the parent study 219538 (NCT05999799) met pre-defined futility criteria.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
FG001
Placebo/GSK1070806 Dose Level 4
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Enrolled Analysis Set. Participants are included in the treatment group in which they entered this long-term extension study (Study 220723 [NCT06447506]).
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 2, 2024
Apr 7, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Italy
Thailand
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
This is a double blinded study until the qualifying parent study has reported out.
Who Masked
ParticipantInvestigator
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
GSK1070806 Dose Level 2/GSK1070806 Dose Level 4
Experimental
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
GSK1070806 Dose Level 3/GSK1070806 Dose Level 3
Experimental
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
GSK1070806 Dose Level 3/GSK1070806 Dose Level 4
Experimental
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
GSK1070806 Dose Level 4/GSK1070806 Dose Level 4
Experimental
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
GSK1070806 Dose Level 2/GSK1070806 Dose Level 2
GSK1070806 Dose Level 2/GSK1070806 Dose Level 4
GSK1070806 Dose Level 3/GSK1070806 Dose Level 3
GSK1070806 Dose Level 3/GSK1070806 Dose Level 4
GSK1070806 Dose Level 4/GSK1070806 Dose Level 4
Placebo/GSK1070806 Dose Level 4
Placebo
Drug
Participants will receive Placebo
Placebo/GSK1070806 Dose Level 4
Placebo/Placebo
Up to Week 59
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
Pompano Beach
Florida
33334
United States
GSK Investigational Site
Fayetteville
Georgia
30214
United States
GSK Investigational Site
New York
New York
10075
United States
GSK Investigational Site
Dublin
Ohio
43016
United States
GSK Investigational Site
Santa Monica
Texas
90404
United States
GSK Investigational Site
Buenos Aires
C1055AAO
Argentina
GSK Investigational Site
Buenos Aires
C1181ACH
Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno
C1056ABI
Argentina
GSK Investigational Site
Córdoba
X5000AAW
Argentina
GSK Investigational Site
Rosario
S2002
Argentina
GSK Investigational Site
Pleven
5800
Bulgaria
GSK Investigational Site
Sofia
1510
Bulgaria
GSK Investigational Site
Barrie
Ontario
L4M 7G1
Canada
GSK Investigational Site
London
Ontario
N6H 5L5
Canada
GSK Investigational Site
Markham
Ontario
L3P1X2
Canada
GSK Investigational Site
Chongqing
400016
China
GSK Investigational Site
Hangzhou
310000
China
GSK Investigational Site
Shanghai
200025
China
GSK Investigational Site
Shanghai
China
GSK Investigational Site
Prague
10034
Czechia
GSK Investigational Site
Prague
Czechia
GSK Investigational Site
La Rochelle
17019
France
GSK Investigational Site
Berlin
10789
Germany
GSK Investigational Site
Münster
48149
Germany
GSK Investigational Site
Athens
Greece
GSK Investigational Site
Chiba
272-0033
Japan
GSK Investigational Site
Fukuoka
807-8556
Japan
GSK Investigational Site
Fukuoka
812-8582
Japan
GSK Investigational Site
Gunma
370-0829
Japan
GSK Investigational Site
Hokkaido
060-0033
Japan
GSK Investigational Site
Hokkaido
080-0013
Japan
GSK Investigational Site
Kanagawa
211-0063
Japan
GSK Investigational Site
Osaka
583-8588
Japan
GSK Investigational Site
Osaka
593-8324
Japan
GSK Investigational Site
Saitama
343-8555
Japan
GSK Investigational Site
Chihuahua City
31000
Mexico
GSK Investigational Site
Durango
34000
Mexico
GSK Investigational Site
Guadalajara
44628
Mexico
GSK Investigational Site
Panama City
7099
Panama
GSK Investigational Site
Elblag
82-300
Poland
GSK Investigational Site
Katowice
40-600
Poland
GSK Investigational Site
Szczecin
70-332
Poland
GSK Investigational Site
Ansan
15355
South Korea
GSK Investigational Site
Seoul
03722
South Korea
GSK Investigational Site
Seoul
04763
South Korea
GSK Investigational Site
Seoul
100 799
South Korea
GSK Investigational Site
Seoul
150-950
South Korea
GSK Investigational Site
Córdoba
14004
Spain
GSK Investigational Site
Granada
18016
Spain
GSK Investigational Site
Vigo
36206
Spain
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
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.
FG007
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.
FG008
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.
FG00311 subjects1 participant had the assigned dose level (DL) modified during the study and was therefore included in the treatment arm corresponding to the highest dose received (participant moved from 'GSK1070806 DL 1/GSK1070806 DL 1' to 'GSK1070806 DL 1/GSK1070806 DL 4).
FG0048 subjects
FG0056 subjects1 participant had the assigned DL modified during the study and was therefore included in the treatment arm corresponding to the highest dose received (participant moved from 'GSK1070806 DL 2/GSK1070806 DL 2' to 'GSK1070806 DL 2/GSK1070806 DL 4).
FG0061 subjects
FG0078 subjects
FG00822 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0003 subjects
FG00113 subjects
FG0023 subjects
FG00310 subjects
FG0049 subjects
FG0055 subjects
FG0061 subjects
FG0078 subjects
FG00827 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0033 subjects
FG004
STUDY TERMINATED BY SPONSOR
FG0002 subjects
FG00110 subjects
FG0022 subjects
FG0037 subjects
FG004
Baseline characteristics were reported for Enrolled Analysis Set which consisted of all participants who signed the informed consent form and entered the study. Participants are included in the treatment group in which they entered the long-term extension study (Study 220723 [NCT06447506]).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
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.
BG008
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.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG00113
BG0023
BG00310
BG0049
BG0055
BG0061
BG0078
BG00827
BG00979
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18 to 64 years
BG0001
BG00113
BG0023
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0018
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
AMERICAN INDIAN OR ALASKA NATIVE
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Safety Analysis Set. 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.
Posted
Count of Participants
Participants
Up to Week 59
ID
Title
Description
OG000
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG00111
OG0020
OG003
Primary
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.
Safety Analysis Set. 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.
Posted
Count of Participants
Participants
Up to Week 59
ID
Title
Description
OG000
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.
OG001
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.
Primary
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.
Safety Analysis Set. 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.
Posted
Count of Participants
Participants
Up to Week 59
ID
Title
Description
OG000
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.
OG001
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.
Primary
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.
Safety Analysis Set. 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.
Posted
Count of Participants
Participants
Up to Week 59
ID
Title
Description
OG000
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.
OG001
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.
OG002
GSK1070806 Dose Level 1/GSK1070806 Dose Level 1
Secondary
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.
Safety Analysis Set.'Overall Number of Participants Analyzed'(N)=participants analyzed(i.e.,contributed to data reported in table) for this outcome measure (OM).'Number Analyzed'=participants evaluable for specified timepoints. At Weeks 16/32/48 for GSK1070806 DL3/GSK1070806 DL3 arm N=0 as a single participant randomized to this arm withdrew prior to Week 16 & no participants were available for evaluation. Baseline=last assessment before first dose on Day1 from parent study 219538(NCT05999799).
Posted
Count of Participants
Participants
Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
ID
Title
Description
OG000
Secondary
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.
Safety Analysis Set. Overall N= only participants analyzed (contributed to data reported in table) for this OM. 'Number Analyzed'=participants evaluable for specified timepoints. At Weeks 16/32/48 for GSK1070806 DL3/ DL3 arm N=0 as single participant assigned to this arm withdrew prior to Week 16 & no participant was available for evaluation. Missing data were imputed as non-responders and included in denominator. Baseline=last assessment before first dose on Day1 from parent study 219538.
Posted
Count of Participants
Participants
Baseline (Day 1 from the parent study), Weeks 16, 32 and 48
ID
Title
Description
OG000
Placebo/Placebo
Secondary
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).
Safety Analysis Set. "Overall Number of Participants Analyzed" (N) = only participants analyzed (contributed to data reported in table) for this OM. 'Number Analyzed (n)'=participants evaluable for specified timepoints. At Weeks 16/32/48 for GSK1070806 DL3/GSK1070806 DL3 arm N=0 as a single participant randomized to this arm withdrew prior to Week 16 & no participants were available for evaluation at specified timepoints.
Posted
Count of Participants
Participants
Baseline (Day -7 to Day -1 from the parent study), Weeks 16, 32, and 48
ID
Title
Description
OG000
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.
Secondary
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.
Safety Analysis Set. 'Overall Number of Participants Analyzed'(N)= only participants who were analyzed (i.e.,contributed to data reported in table) for this OM. 'Number Analyzed'=participants evaluable for specified timepoints. At Weeks 16/32/48 for GSK1070806 DL3/GSK1070806 DL3 arm N=0 as a single participant randomized to this arm withdrew prior to Week 16 & no participants were available for evaluation. Baseline=last assessment before first dose on Day1 from parent study 219538(NCT05999799).
Posted
Count of Participants
Participants
Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
ID
Title
Description
OG000
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.
Secondary
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.
Safety Analysis Set.Overall analyzed(N)=participants contributing to this OM.'Number Analyzed'=participants evaluable at specified timepoints.At Weeks16/32/48 for GSK1070806 DL3/DL3,N=0 as single participant randomized withdrew prior to Week16 & no participant was available for evaluation.Baseline=last pre-dose Day1 assessment from parent study.'n' for Week16=Week16 responders with non-missing data.At later timepoints, n=participants from this subset with observed responses prior to withdrawal.
Posted
Count of Participants
Participants
Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
ID
Title
Description
OG000
Placebo/Placebo
Secondary
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.
Safety Analysis Set. 'Overall Number of Participants Analyzed'(N)= only participants who were analyzed (i.e.,contributed to data reported in table) for this OM. 'Number Analyzed'=participants evaluable for specified timepoints. At Weeks 16/32/48 for GSK1070806 DL3/GSK1070806 DL3 arm N=0 as a single participant randomized to this arm withdrew prior to Week 16 & no participants were available for evaluation. Baseline=last assessment before first dose on Day1 from parent study 219538(NCT05999799).
Posted
Mean
Standard Deviation
Percent change
Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
ID
Title
Description
OG000
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.
Time Frame
All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 59
Description
Safety Analysis Set: all participants who received at least 1 dose of study intervention in this LTE study. Participants were analyzed by the intervention they actually received. 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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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.
0
3
1
3
0
3
EG001
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.
0
13
0
13
11
13
EG002
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.
0
2
0
2
1
2
EG003
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.
0
11
1
11
6
11
EG004
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.
0
8
0
8
4
8
EG005
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.
0
6
0
6
5
6
EG006
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.
0
1
0
1
1
1
EG007
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.
0
8
0
8
5
8
EG008
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.
0
27
0
27
10
27
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cellulitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG0031 events1 affected11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
Necrotising soft tissue infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA v28.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected27 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sudden hearing loss
Ear and labyrinth disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Food allergy
Immune system disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
COVID-19
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Furuncle
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gingivitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Impetigo
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Influenza
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0021 events1 affected2 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Blood fibrinogen decreased
Investigations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0013 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Glucose urine present
Investigations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
White blood cell count decreased
Investigations
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Metabolic syndrome
Metabolism and nutrition disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Alopecia areata
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Onycholysis
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Urticaria cholinergic
Skin and subcutaneous tissue disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected13 at risk
EG0020 events0 affected2 at risk
EG003
Hypertension
Vascular disorders
MedDRA v28.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected13 at risk
EG0020 events0 affected2 at risk
EG003
This study was terminated after the parent study 219538 (NCT05999799) met pre-defined futility criteria.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D017443
Skin Diseases, Eczematous
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000608195
GSK1070806
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
4 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0087 subjects
5 subjects
FG0054 subjects
FG0060 subjects
FG0077 subjects
FG00820 subjects
10
BG0049
BG0055
BG0061
BG0078
BG00826
BG00976
>=65 to 84 years
BG0002
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
BG0093
0
BG0035
BG0042
BG0050
BG0060
BG0071
BG00812
BG00929
Male
BG0002
BG0015
BG0023
BG0035
BG0047
BG0055
BG0060
BG0077
BG00815
BG00949
Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0091
0
BG0031
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
ASIAN
BG0002
BG0017
BG0020
BG0035
BG0044
BG0052
BG0061
BG0073
BG00811
BG00935
BLACK OR AFRICAN AMERICAN
BG0000
BG0011
BG0021
BG0030
BG0040
BG0050
BG0060
BG0072
BG0080
BG0094
WHITE
BG0001
BG0014
BG0021
BG0032
BG0045
BG0052
BG0060
BG0073
BG00813
BG00931
MIXED RACE
BG0000
BG0011
BG0020
BG0031
BG0040
BG0050
BG0060
BG0070
BG0081
BG0093
NOT REPORTED
BG0000
BG0010
BG0021
BG0031
BG0040
BG0051
BG0060
BG0070
BG0082
BG0095
11
OG0048
OG0056
OG0061
OG0078
OG00827
6
OG0043
OG0054
OG0061
OG0075
OG00811
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG00311
OG0048
OG0056
OG0061
OG0078
OG00827
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG00311
OG0048
OG0056
OG0061
OG0078
OG00827
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0003
OG00113
OG0022
OG00311
OG0048
OG0056
OG0061
OG0078
OG00827
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0002
OG00111
OG0022
OG00311
OG0045
OG0056
OG0060
OG0078
OG00824
Title
Denominators
Categories
Week 16
ParticipantsOG0002
ParticipantsOG00111
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0060
ParticipantsOG0078
ParticipantsOG00824
Title
Measurements
OG0002
OG0014
OG0021
OG003
Week 32
ParticipantsOG0001
ParticipantsOG00110
ParticipantsOG0020
ParticipantsOG0035
Week 48
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0002
OG00111
OG0022
OG00311
OG0045
OG0056
OG0060
OG0078
OG00824
Title
Denominators
Categories
Week 16
ParticipantsOG0002
ParticipantsOG00111
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0060
ParticipantsOG0078
ParticipantsOG00824
Title
Measurements
OG0002
OG0018
OG0021
OG003
Week 32
ParticipantsOG0001
ParticipantsOG00110
ParticipantsOG0020
ParticipantsOG0035
Week 48
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0002
OG00111
OG0022
OG00311
OG0045
OG0055
OG0060
OG0078
OG00818
Title
Denominators
Categories
Week 16
ParticipantsOG0002
ParticipantsOG00111
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0045
ParticipantsOG0055
ParticipantsOG0060
ParticipantsOG0078
ParticipantsOG00818
Title
Measurements
OG0001
OG0016
OG0021
OG003
Week 32
ParticipantsOG0001
ParticipantsOG0019
ParticipantsOG0020
ParticipantsOG0034
Week 48
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0002
OG0014
OG0021
OG0031
OG0044
OG0051
OG0060
OG0071
OG0089
Title
Denominators
Categories
Week 16
ParticipantsOG0002
ParticipantsOG0014
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0044
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0089
Title
Measurements
OG0002
OG0014
OG0021
OG003
Week 32
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0030
Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
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.
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0002
OG0018
OG0021
OG0031
OG0045
OG0052
OG0060
OG0072
OG00812
Title
Denominators
Categories
Week 16
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG0021
ParticipantsOG0031
ParticipantsOG0045
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0072
ParticipantsOG00812
Title
Measurements
OG0002
OG0018
OG0021
OG003
Week 32
ParticipantsOG0001
ParticipantsOG0017
ParticipantsOG0020
ParticipantsOG0030
Week 48
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0030
OG001
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.
OG002
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.
OG003
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.
OG004
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.
OG005
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.
OG006
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.
OG007
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.
OG008
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.
Units
Counts
Participants
OG0002
OG00111
OG0022
OG00311
OG0045
OG0056
OG0060
OG0077
OG00822
Title
Denominators
Categories
Week 16
ParticipantsOG0002
ParticipantsOG00111
ParticipantsOG0022
ParticipantsOG00311
ParticipantsOG0045
ParticipantsOG0056
ParticipantsOG0060
ParticipantsOG0077
ParticipantsOG00822
Title
Measurements
OG000-98.94± 1.498
OG001-80.32± 17.697
OG002-66.76± 47.012
OG003
Week 32
ParticipantsOG0001
ParticipantsOG00110
ParticipantsOG0020
ParticipantsOG0034
Week 48
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0020
ParticipantsOG0030
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0072 events2 affected8 at risk
EG0080 events0 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected6 at risk
EG0061 events1 affected1 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected27 at risk
4 events
4 affected
11 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0073 events2 affected8 at risk
EG0082 events2 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0082 events2 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
2 events
2 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected27 at risk
1 events
1 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected1 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected27 at risk
0 events
0 affected
11 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected27 at risk
1
OG0044
OG0051
OG0071
OG0089
Participants
OG004
4
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG00814
Title
Measurements
OG0001
OG0013
OG0031
OG0044
OG0052
OG0070
OG0082
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0082
Title
Measurements
OG0011
OG0070
OG0080
1
OG0045
OG0052
OG0072
OG00812
Participants
OG004
4
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG00814
Title
Measurements
OG0001
OG0015
OG0033
OG0044
OG0052
OG0070
OG0086
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0082
Title
Measurements
OG0011
OG0071
OG0080
2
OG0040
OG0052
OG0072
OG0083
Participants
OG004
4
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG00810
Title
Measurements
OG0000
OG0015
OG0031
OG0043
OG0051
OG0070
OG0082
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
Title
Measurements
OG0010
OG0070
OG0080
1
OG0044
OG0051
OG0071
OG0089
Participants
OG004
3
ParticipantsOG0051
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0083
Title
Measurements
OG0001
OG0012
OG0043
OG0051
OG0081
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
1
OG0045
OG0052
OG0072
OG00812
Participants
OG004
4
ParticipantsOG0052
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0086
Title
Measurements
OG0001
OG0014
OG0044
OG0052
OG0070
OG0085
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0081
Title
Measurements
OG0010
OG0080
-32.79
± 49.095
OG004-95.82± 3.520
OG005-65.75± 22.276
OG007-52.44± 20.855
OG008-63.14± 36.841
Participants
OG004
4
ParticipantsOG0054
ParticipantsOG0060
ParticipantsOG0074
ParticipantsOG00814
Title
Measurements
OG000-98.31± NAStandard deviation could not be calculated for a single participant.
OG001-71.63± 30.130
OG003-71.33± 26.153
OG004-94.97± 6.004
OG005-61.76± 38.208
OG007-53.49± 21.065
OG008-53.15± 40.480
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0081
Title
Measurements
OG001-86.97± 17.571
OG007-94.15± NAStandard deviation could not be calculated for a single participant.
OG008-60.37± NAStandard deviation could not be calculated for a single participant.