Last updated: 08/06/2025 13:40:14
Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase Ib, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Clinical Effect, Safety and Tolerability of a Single Intravenous Infusion of GSK1070806 in Moderate to Severe Atopic Dermatitis Patients
Trial description: This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 12 in Group 1
Timeframe: Baseline and at Week 12
Secondary outcomes:
Change from Baseline in EASI at Week 12 in Group 1
Timeframe: Baseline and at Week 12
Percentage of participants achieving >=50/75/90 percent reduction in EASI from Baseline at Week 12 in Group 1
Timeframe: Baseline to Week 12
Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1
Timeframe: At Week 12
Percent Change from Baseline in EASI at Week 12 in Group 2
Timeframe: Baseline and at Week 12
Number of Participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) - Groups 1 and 2
Timeframe: Up to Week 24
Number of Participants with Clinically Significant findings in Vital signs, 12-lead Electrocardiogram (ECG) and Laboratory Parameters- Groups 1 and 2
Timeframe: Up to Week 24
Number of Participants With Positive Anti-drug Antibodies (ADA)- Groups 1 and 2
Timeframe: Up to Week 24
Interventions:
Enrollment:
34
Primary completion date:
2022-19-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Dermatitis, Atopic
Product
GSK1070806
Collaborators
Not applicable
Study date(s)
November 2021 to March 2023
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 75 Years
Accepts healthy volunteers
No
- Inclusion criteria:
- Moderate to severe AtD (confirmed by a dermatologist) according to the Hannifin and Rajka criteria or Eichenfield revised criteria.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Moderate to severe AtD (confirmed by a dermatologist) according to the Hannifin and Rajka criteria or Eichenfield revised criteria.
- Onset of AtD symptoms occurring at least 6 months prior to Screening, with stable disease for at least 1 month prior to Screening.
- Eczema Activity Severity Index greater than or equal to (>=)16; Investigator Global Assessment score >=3.
- Group 1- Biologic Naïve: Topical First Line Treatment: Documented recent history (within 6 months before Screening) of: a) either an inadequate response (IR) to out-patient treatment with at least one topical treatment (intermittent topical corticosteroid, topical calcineurin inhibitor), topical inhibitors or Phosphodiesterase 4 inhibitor (Crisaborole); b) or that topical treatments were otherwise not recommended.
- Group 2- Dupilumab-Inadequate Responder: Documented history of an IR to dupilumab: a) either following at least 16 weeks of treatment according to the Investigator’s judgement; b) or intolerant to dupilumab owing to adverse events. Exclusion Criteria:
- Other than AtD, the presence of a significant skin morbidity that will influence the Investigator’s ability to assess the severity of the disease (e.g. psoriasis, confirmed or suspected cutaneous T-cell lymphoma, autoimmune bullous disease, fixed drug reaction and Stevens Johnson Syndrome).
- Participants with any uncontrolled medical conditions, other than AtD, that in the opinion of the investigator puts the participant at unacceptable risk or will likely interfere with study assessments or data integrity. Other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study.
- Treatment with biologic agents (investigational and marketed monoclonal antibodies) within 12 weeks or 5 pharmacokinetic half-lives (whichever is longer) prior dosing on Day 1.
- Treatment with Janus Activated Kinase inhibitors (e.g. baricitinib, upadacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to dosing on Day 1.
- Mycophenolate mofetil, azathioprine, methotrexate, or calcineurin inhibitors within 4 weeks of Screening.
Trial location(s)
Location
GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78218
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77479
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73118
Status
Study Complete
Showing 1 - 6 of 11 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2022-19-12
Actual study completion date
2023-13-03
Plain language summaries
Summary of results in plain language
Available language(s): English, Spanish (United States)
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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