GSK1070806 for Atopic Dermatitis

(AtDventure Trial)

Recruiting at 103 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Infections, Hypertension, Liver disease, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

163 Participants Needed

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. ^{1 2 3 4 5}

What 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. ^{1 3 4 5 6}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility 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.

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

Treatment Details

Interventions

• GSK1070806

Trial Overview 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.

Participant Groups

Group I: GSK1070806 Dose 4 Experimental Treatment 1 Intervention

Participants will receive GSK1070806 dose 4.

Group II: GSK1070806 Dose 3 Experimental Treatment 1 Intervention

Participants will receive GSK1070806 dose 3.

Group III: GSK1070806 Dose 2 Experimental Treatment 1 Intervention

Participants will receive GSK1070806 dose 2.

Group IV: GSK1070806 Dose 1 Experimental Treatment 1 Intervention

Participants will receive GSK1070806 dose 1.

Group V: Placebo Placebo Group 1 Intervention

Participants will receive placebo.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

Patients with atopic dermatitis have significantly higher serum levels of IL-18 compared to healthy individuals, indicating its potential role in the disease's pathology (332 pg/mL vs 151 pg/mL).

Serum IL-18 levels correlate with the severity of atopic dermatitis, suggesting it could be an independent predictor of disease severity, although its clinical utility as a test needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical significance of serum interleukin-18 concentration in the patients with atopic dermatitis]. Park, DS., Youn, YH.[2019]

In a study of 10 patients with severe atopic dermatitis (AD) treated with recombinant human interferon gamma (rhINF-gamma) for 4 weeks, significant clinical improvement was observed starting from the third week, particularly in symptoms like erythema, dryness, and lichenification.

The treatment appears to work by inhibiting T-cell activation, as indicated by a decrease in the T-cell activation marker CD 25, while serum immunoglobulin levels and eosinophil counts showed little change, suggesting a targeted mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Human recombinant interferon gamma in the treatment of atopic dermatitis]. Musiał, J., Milewski, M., Undas, A., et al.[2017]

In a study of 83 patients with moderate to severe atopic dermatitis, treatment with recombinant interferon-gamma (rIFN-gamma) for 12 weeks resulted in a significant improvement in symptoms, with 45% of patients showing over 50% improvement compared to 21% in the placebo group.

rIFN-gamma was found to be safe and well-tolerated, with manageable side effects such as headaches and chills, and it effectively reduced inflammation and eosinophil counts, indicating its potential as a therapeutic option for atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant interferon gamma therapy for atopic dermatitis. Hanifin, JM., Schneider, LC., Leung, DY., et al.[2019]

Patients with severe atopic dermatitis (AD) have significantly higher levels of serum IL-18 compared to healthy individuals, suggesting a potential role of IL-18 in the disease's development.

The study indicates that IL-18 may contribute to the production of Th2-related cytokines in AD, as evidenced by increased IL-18 secretion from immune cells in response to stimulation, highlighting its importance in the inflammatory processes of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interleukin-18 is associated with increased severity of atopic dermatitis in children. Sohn, MH., Lee, KE., Kim, KE.[2018]

Long-term treatment with recombinant interferon-gamma (rIFN-gamma) for severe atopic dermatitis in 15 patients over a minimum of 22 months resulted in significant improvements, with total body surface area involvement decreasing from 61.6% to 18.5%.

The therapy was found to be safe, with no significant laboratory abnormalities or growth issues reported, while also leading to a reduction in clinical severity scores from 11.4 to 6.3.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term therapy with recombinant interferon-gamma (rIFN-gamma) for atopic dermatitis. Schneider, LC., Baz, Z., Zarcone, C., et al.[2011]

In a study of 334 patients with atopic dermatitis, a specific haplotype (IL10-ht2) in the IL10 gene was linked to lower levels of total serum IgE, suggesting a genetic influence on immune response in these patients.

The findings indicate that increased production of IL-10, associated with the IL10-ht2 haplotype, may inhibit innate immunity and contribute to reduced IgE levels, highlighting the importance of genetic factors in atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interleukin-10 haplotype associated with total serum IgE in atopic dermatitis patients. Shin, HD., Park, BL., Kim, LH., et al.[2006]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

[Clinical significance of serum interleukin-18 concentration in the patients with atopic dermatitis]. [2019]

2. Poland pubmed.ncbi.nlm.nih.gov

[Human recombinant interferon gamma in the treatment of atopic dermatitis]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Recombinant interferon gamma therapy for atopic dermatitis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Interleukin-18 is associated with increased severity of atopic dermatitis in children. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term therapy with recombinant interferon-gamma (rIFN-gamma) for atopic dermatitis. [2011]

6. Denmark pubmed.ncbi.nlm.nih.gov

Interleukin-10 haplotype associated with total serum IgE in atopic dermatitis patients. [2006]