Clinical trial NCT04975438: Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Atopic
Keywords: Eczema activity severity index
GSK1070806
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate efficacy and safety of GSK1070806 in moderate to severe atopic dermatitis (AtD) participants.


Eligibility 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.

Primary outcomes:
measure: Percent Change From Baseline (PCFB) in Eczema Area and Severity Index (EASI) Score at Week 12 in Group 1
timeFrame: Baseline (Day 1) and at Week 12
Secondary outcomes:
measure: Change From Baseline in EASI Score at Week 12 in Group 1
timeFrame: Baseline (Day 1) and at Week 12
measure: Number of Participants Achieving EASI-50, ≥ 50% Reduction in EASI Score at Week 12 in Group 1
timeFrame: At Week 12
measure: Number of Participants Achieving EASI-75, ≥ 75% Reduction in EASI Score at Week 12 in Group 1
timeFrame: At Week 12
measure: Number of Participants Achieving EASI-90, ≥ 90% Reduction in EASI Score at Week 12 in Group 1
timeFrame: At Week 12
measure: Number of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 at Week 12 in Group 1
timeFrame: At Week 12
measure: Percent Change From Baseline in EASI Score at Week 12 in Group 2
timeFrame: Baseline (Day 1) and at Week 12
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Groups 1 and 2
timeFrame: Up to Week 24
measure: Number of Participants With Worst Case Vital Signs Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2
timeFrame: Up to Week 24
measure: Number of Participants With Worst Case 12-lead Electrocardiogram (ECG) Post-Baseline Relative to Baseline - Groups 1 and 2
timeFrame: Up to Week 24
measure: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline - Groups 1 and 2
timeFrame: Up to Week 24
measure: Number of Participants With Worst Case Chemistry Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2
timeFrame: Up to Week 24
measure: Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline - Groups 1 and 2
timeFrame: Up to Week 25
measure: Number of Participants With Anti-drug Antibodies (ADA)- Groups 1 and 2
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Troy
country: United States
facility: GSK Investigational Site
state: Michigan
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: GSK Investigational Site
state: Texas
city: Edmonton
country: Canada
facility: GSK Investigational Site
state: Alberta
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: