GSK1070806 for Atopic Dermatitis
(AtDventure Trial)
Recruiting in Palo Alto (17 mi)
+95 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: GlaxoSmithKline
Must not be taking: Antibiotics, Antivirals, Antifungals, others
Disqualifiers: Infections, Hypertension, Liver disease, Cancer, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have a chronic or acute infection requiring treatment, you may not be eligible to participate.
What data supports the effectiveness of the drug GSK1070806 for atopic dermatitis?
Research suggests that recombinant interferon gamma, which is related to the components of GSK1070806, has shown effectiveness in improving symptoms of severe atopic dermatitis, such as redness and dryness, by reducing immune system overactivity.
12345What makes the drug GSK1070806 unique for treating atopic dermatitis?
GSK1070806 is unique because it targets interleukin-18 (IL-18), a protein linked to the severity of atopic dermatitis, by inducing interferon-gamma (IFN-gamma) production, which is typically reduced in this condition. This approach differs from other treatments that may not specifically address the IL-18 and IFN-gamma imbalance in atopic dermatitis.
13456Eligibility Criteria
Adults aged 18-75 with moderate to severe Atopic Dermatitis (AD), covering at least 10% of their body, who have tried and stopped other AD treatments due to intolerance, ineffectiveness, or access issues. They must have had AD for over a year and currently experience significant itching.Inclusion Criteria
I experience itching at a severity of at least 3 out of 10.
My skin condition affects 10% or more of my body.
I have been diagnosed with AtD for at least 1 year.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive GSK1070806 or placebo for 16 weeks to evaluate efficacy, safety, pharmacokinetics, and pharmacodynamics
16 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Participant Groups
The trial is testing GSK1070806's safety and effectiveness compared to a placebo in adults with moderate to severe AD. It's designed as a parallel group study where participants are randomly assigned to receive either the drug or placebo.
5Treatment groups
Experimental Treatment
Placebo Group
Group I: GSK1070806 Dose 4Experimental Treatment1 Intervention
Participants will receive GSK1070806 dose 4.
Group II: GSK1070806 Dose 3Experimental Treatment1 Intervention
Participants will receive GSK1070806 dose 3.
Group III: GSK1070806 Dose 2Experimental Treatment1 Intervention
Participants will receive GSK1070806 dose 2.
Group IV: GSK1070806 Dose 1Experimental Treatment1 Intervention
Participants will receive GSK1070806 dose 1.
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
GSK Investigational SitePompano Beach, FL
GSK Investigational SiteTroy, MI
GSK Investigational SiteSanta Monica, CA
GSK Investigational SiteChicago, IL
More Trial Locations
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Who Is Running the Clinical Trial?
GlaxoSmithKlineLead Sponsor
References
[Clinical significance of serum interleukin-18 concentration in the patients with atopic dermatitis]. [2019]Interleukin (IL)-18, a potent inducer of interferon gamma (IFN-gamma), is known to have a role in diseases involving type-2 T helper cell responses including atopic dermatitis. In this study, we aimed to determine the clinical significance of serum IL-18 level in the patients with atopic dermatitis.
[Human recombinant interferon gamma in the treatment of atopic dermatitis]. [2017]Atopic dermatitis (AD) is a chronic relapsing skin disease characterized by various immunologic abnormalities. We have studied the efficacy of recombinant human interferon gamma (rhINF-gamma) administered subcutaneously at a dose of 0.05 mg/m2 in ten patients with severe AD. Patients were treated for 4 weeks. They have shown marked clinical improvement starting from the third week of treatment. The efficacy of the drug varied, with erythema, dryness and lichenification being the most responsive symptoms. There was no change in serum immunoglobulin E and IgG4 levels. Whole blood eosinophil count decreased only transiently and was accompanied by a tendency to lower values of serum eosinophil cationic protein. Patient with AD showed an increased expression of a T-cell surface activation marker CD 25 as compared to healthy controls. Moreover, clinical improvement was roughly paralleled by the decrease in this T-cell activation marker. We conclude that rhINF-gamma is a novel efficacious therapeutic approach in severe AD. We suggest that its primary action might be related to the inhibition of T-cell activation.
Recombinant interferon gamma therapy for atopic dermatitis. [2019]Atopic dermatitis is characterized by immunologic abnormalities including evidence for reduced interferon gamma production. Therapeutic options for treatment of atopic dermatitis are limited and unsatisfactory. Previous open trials have suggested efficacy for recombinant interferon-gamma (rIFN-gamma) in treatment of severe atopic dermatitis. We describe the results of treatment with rIFN-gamma, assessing clinical, immunologic, and laboratory safety parameters in 83 patients with moderate to severe atopic dermatitis.
Interleukin-18 is associated with increased severity of atopic dermatitis in children. [2018]Atopic dermatitis (AD) is a chronic relapsing skin disease characterized by reduced interferon (IFN) gamma production with concurrent up-regulation of interleukin (IL)-4. Recently, it was reported that IL-18, formerly called IFN gamma-inducing factor, induces the production of T helper (Th)2-related cytokines without help from IL-12. This study was performed to evaluate the contribution of IL-18 in the pathogenesis of AD. Significantly higher serum IL-18 concentrations were found in patients with severe AD than in healthy subjects. Under staphylococcal enterotoxin B stimulation, IL-18 secretion was increased in peripheral blood mononuclear cells from patients with AD. There were significant differences in the concentrations of IL-10, IL-12, and soluble Fas ligand between AD patients and normal controls. In conclusion, increased serum IL-18 concentrations may be involved in the pathogenesis of AD.
Long-term therapy with recombinant interferon-gamma (rIFN-gamma) for atopic dermatitis. [2011]Interferon-gamma (IFN-gamma) is a potent cytokine that modulates IL-4-induced immune responses. Atopic dermatitis is associated with increased IgE levels and decreased IFN-gamma production. Recent phase I and phase II studies have suggested that short-term rIFN-gamma therapy is effective in the treatment of severe atopic dermatitis.
Interleukin-10 haplotype associated with total serum IgE in atopic dermatitis patients. [2006]The genetic background of atopic dermatitis (AD) is not clearly understood. Interleukin (IL)-10 is a powerful Th-2 cell cytokine produced by lymphoid cells that exerts its function by inhibiting macrophage/monocyte and T-cell lymphocyte replication and secretion of inflammatory cytokines [IL-1, tumour necrosis factor-alpha (TNFA), IL-6, IL-8 and IL-12].