Clinical Effect, Safety and Tolerability of GSK1070806 in Atopic Dermatitis

Recruiting at 10 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: GlaxoSmithKline

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: Psoriasis, Lymphoma, Bullous disease, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called GSK1070806 to see if it can help people with moderate to severe atopic dermatitis by reducing inflammation and itching.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. Specifically, you must stop using biologic agents at least 12 weeks before the trial, and Janus Activated Kinase inhibitors, mycophenolate mofetil, azathioprine, methotrexate, or calcineurin inhibitors at least 4 weeks before the trial.

Is the treatment generally safe for humans?

The research articles do not provide specific safety data for humans regarding the treatment, but they describe its biological activities, such as enhancing immune cell functions and cytokine production. This information suggests potential effects on the immune system, but does not directly address safety in humans. ^{1 2 3 4 5}

What makes the drug GSK1070806 unique compared to other treatments?

GSK1070806, also known as IL-18 or IGIF, is unique because it enhances the production of interferon-gamma, a protein that helps activate immune cells, and works synergistically with another protein, IL-12, to boost immune responses. This makes it potentially effective in treating conditions where enhancing the immune system is beneficial, such as infections, tumors, and inflammatory diseases. ^{2 5 6 7 8}

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

Your eczema is severe, with a score of 16 or higher on the Eczema Activity Severity Index or a rating of 3 or higher on the Investigator Global Assessment.

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous infusion of GSK1070806 or placebo on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Regular visits (frequency not specified)

Extended Follow-up

Participants are monitored for adverse events and other safety measures

Up to 24 weeks

Treatment Details

Interventions

• GSK1070806
• Placebo

Participant Groups

Group I: Group 2: Dupilumab-IR with GSK1070806 Experimental Treatment 1 Intervention

Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.

Group II: Group 1: GSK1070806 Experimental Treatment 1 Intervention

Participants received a single dose of 2 mg/kg GSK1070806 as intravenous infusion on Day 1.

Group III: Group 2: Dupilumab IR with Placebo Placebo Group 1 Intervention

Participants received Placebo as intravenous infusion on Day 1.

Group IV: Group 1: Placebo Placebo Group 1 Intervention

Participants received Placebo as intravenous infusion on Day 1.

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

IL-18 is a pro-inflammatory cytokine that plays a crucial role in the immune response by inducing Th1 cytokines and enhancing cell-mediated immune cytotoxicity, making it important in fighting tumors and infections.

Recent research has advanced our understanding of IL-18's structure, processing, and receptor interactions, highlighting its potential as a target for therapeutic modulation in autoimmune and inflammatory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interleukin-18 and new drugs. Protective effect against tumor growth and infections]. Wollheim, FA.[2006]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Comparison of the effects of interleukin-1 alpha, interleukin-1 beta and interferon-gamma-inducing factor on the production of interferon-gamma by natural killer. [2008]

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

Cloning of the cDNA for human IFN-gamma-inducing factor, expression in Escherichia coli, and studies on the biologic activities of the protein. [2022]

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

Interferon-gamma-inducing factor elicits antitumor immunity in association with interferon-gamma production. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A simple and sensitive bioassay for the detection of human interleukin-18/interferon-gamma-inducing factor using human myelomonocytic KG-1 cells. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Interferon-gamma-inducing factor enhances T helper 1 cytokine production by stimulated human T cells: synergism with interleukin-12 for interferon-gamma production. [2008]

6. France pubmed.ncbi.nlm.nih.gov

Interleukin-18: biological properties and clinical implications. [2006]

7. Sweden pubmed.ncbi.nlm.nih.gov

[Interleukin-18 and new drugs. Protective effect against tumor growth and infections]. [2006]

8. England pubmed.ncbi.nlm.nih.gov

IL-1H, an interleukin 1-related protein that binds IL-18 receptor/IL-1Rrp. [2014]