Dermatitis, Atopic
Conditions
Keywords
Atopic dermatits, Dermatitis, Eczema, GSK1070806, Safety, Efficacy, Immune system Disease
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).
Interventions
DRUGGSK1070806
Participants will receive GSK1070806
DRUGPlacebo
Participants will receive Placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double blinded study until the qualifying parent study has reported out.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to Week 59 | 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. |
| Number of Participants With TEAEs Leading to Permanent Discontinuation | Up to Week 59 | 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. |
| Number of Participants With Serious Adverse Events (SAEs) | Up to Week 59 | 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. |
| Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESI) | Up to Week 59 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (Day 1 from the parent study), 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. |
| 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 | Baseline (Day 1 from the parent study), 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. |
| 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 | Baseline (Day -7 to Day -1 from the parent study), 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). |
| 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 | Baseline (Day 1 from the parent study), 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. |
| Number of Participants Who Maintained Response of Reduction of >= 75% in EASI Score From Baseline at Weeks 16, 32, and 48 | Baseline (Day 1 from the parent study), 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. |
| Percent Change From Baseline (CFB) in EASI Score at Weeks 16, 32, and 48 | Baseline (Day 1 from the parent study), 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. |
Countries
Argentina, Bulgaria, Canada, China, Czechia, France, Germany, Greece, Japan, Mexico, Panama, Poland, South Korea, Spain, United States
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Participant flow
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 18 to 64 years | 76 Participants |
| Age, Customized >=65 to 84 years | 3 Participants |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 0 Participants |
| Race/Ethnicity, Customized ASIAN | 35 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 1 Participants |
| Race/Ethnicity, Customized MIXED RACE | 3 Participants |
| Race/Ethnicity, Customized NOT REPORTED | 5 Participants |
| Race/Ethnicity, Customized WHITE | 13 Participants |
| Sex/Gender, Customized Female | 29 Participants |
| Sex/Gender, Customized Male | 15 Participants |
| Sex/Gender, Customized Not Reported | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 13 | 0 / 2 | 0 / 11 | 0 / 8 | 0 / 6 | 0 / 1 | 0 / 8 | 0 / 27 |
| other Total, other adverse events | 0 / 3 | 11 / 13 | 1 / 2 | 6 / 11 | 4 / 8 | 5 / 6 | 1 / 1 | 5 / 8 | 10 / 27 |
| serious Total, serious adverse events | 1 / 3 | 0 / 13 | 0 / 2 | 1 / 11 | 0 / 8 | 0 / 6 | 0 / 1 | 0 / 8 | 0 / 27 |
Outcome results
None listed