Dermatitis, AtopicPhase 2AtDvanceNCT06447506
Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.
A Phase 2 study testing GSK1070806 in people with Dermatitis, Atopic, run by GlaxoSmithKline at 51 sites in 15 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- GSK1070806
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 51 sitesin 15 countries
- Study dates
- 5 Jun 2024to 29 Jul 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
51 sites in 15 countries.
51 sites in 15 countries
Japan10 sites
GSK Investigational Site
Chiba, 272-0033
GSK Investigational Site
Fukuoka, 807-8556
GSK Investigational Site
Fukuoka, 812-8582
GSK Investigational Site
Gunma, 370-0829
GSK Investigational Site
Hokkaido, 060-0033
GSK Investigational Site
Hokkaido, 080-0013
GSK Investigational Site
Kanagawa, 211-0063
GSK Investigational Site
Osaka, 583-8588
GSK Investigational Site
Osaka, 593-8324
GSK Investigational Site
Saitama, 343-8555
United States6 sites
GSK Investigational Site
Dublin, Ohio, 43016
GSK Investigational Site
Fayetteville, Georgia, 30214
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
New York, New York, 10075
GSK Investigational Site
Pompano Beach, Florida, 33334
GSK Investigational Site
Santa Monica, Texas, 90404
Argentina5 sites
GSK Investigational Site
Buenos Aires, C1055AAO
GSK Investigational Site
Buenos Aires, C1181ACH
GSK Investigational Site
Ciudad Autonoma de Bueno, C1056ABI
GSK Investigational Site
Córdoba, X5000AAW
GSK Investigational Site
Rosario, S2002
South Korea5 sites
GSK Investigational Site
Ansan, 15355
GSK Investigational Site
Seoul, 03722
GSK Investigational Site
Seoul, 04763
GSK Investigational Site
Seoul, 100 799
GSK Investigational Site
Seoul, 150-950
China4 sites
GSK Investigational Site
Chongqing, 400016
GSK Investigational Site
Hangzhou, 310000
GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Shanghai
Canada3 sites
GSK Investigational Site
Barrie, Ontario, L4M 7G1
GSK Investigational Site
London, Ontario, N6H 5L5
GSK Investigational Site
Markham, Ontario, L3P1X2
Mexico3 sites
GSK Investigational Site
Chihuahua City, 31000
GSK Investigational Site
Durango, 34000
GSK Investigational Site
Guadalajara, 44628
Poland3 sites
GSK Investigational Site
Elblag, 82-300
GSK Investigational Site
Katowice, 40-600
GSK Investigational Site
Szczecin, 70-332
Spain3 sites
GSK Investigational Site
Córdoba, 14004
GSK Investigational Site
Granada, 18016
GSK Investigational Site
Vigo, 36206
Bulgaria2 sites
GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Sofia, 1510
Czechia2 sites
GSK Investigational Site
Prague, 10034
GSK Investigational Site
Prague
Germany2 sites
GSK Investigational Site
Berlin, 10789
GSK Investigational Site
Münster, 48149
About this study
Official title: Long-Term Extension Study (AtDvance) to Evaluate the Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis.
The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).
- Conditions
- Dermatitis, Atopic
- Being tested
- GSK1070806, Placebo
- Keywords
- Atopic dermatits, Dermatitis, Eczema, GSK1070806, Safety, Efficacy, Immune system Disease
- Medical subject headings
- Dermatitis, Atopic, Dermatitis, Eczema, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1070806Drug
Participants will receive GSK1070806
PlaceboDrug
Participants will receive Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: GSK1070806 |
| GSK1070806 Dose Level 2/GSK1070806 Dose Level 2 | Experimental | 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: GSK1070806 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 59
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1 from the parent study), Weeks 16, 32, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start5 Jun 2024
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447506
- Sponsor's protocol ID
- 220723
- Other IDs
- 2023-508474-29-00, 2023
- Acronym
- AtDvance
- Status last verified
- May 2026
- First submitted
- 3 Jun 2024
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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