GSK1070806 for Atopic Dermatitis

(AtDventure Trial)

No longer recruiting at 117 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, GSK1070806, for individuals with moderate to severe Atopic Dermatitis, a skin condition causing itchiness and redness. The researchers aim to determine the treatment's effectiveness and safety compared to a placebo, which has no therapeutic effect. Participants will be divided into groups to receive different doses of the treatment or the placebo. This trial may suit adults who have had Atopic Dermatitis for at least a year and have not found sufficient relief from prescription creams or past biologic treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GSK1070806 has promising safety results. Patients with moderate-to-severe atopic dermatitis (AD) who received GSK1070806 reported better outcomes than those who received a placebo, indicating that the treatment was well-tolerated.

Ongoing research continues to explore the long-term safety of GSK1070806. So far, studies with adults who have moderate to severe AD have found no major safety issues. Since this trial is in the early stages, the treatment has passed some initial safety checks but requires further testing to ensure safety for everyone. Always consult your healthcare provider before joining a trial to understand the potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for Atopic Dermatitis?

Unlike the standard treatments for atopic dermatitis, which often include topical corticosteroids and calcineurin inhibitors, GSK1070806 is unique because it targets a different pathway in the immune system. Researchers are excited about this treatment because it focuses on blocking interleukin-36, a cytokine involved in inflammatory responses, offering a fresh approach to reducing symptoms. This targeted mechanism could potentially provide relief for patients who don't respond well to current therapies. Additionally, GSK1070806 is being tested in multiple doses, which might help fine-tune the effectiveness and minimize side effects, offering a more personalized treatment option.

What evidence suggests that this trial's treatments could be effective for Atopic Dermatitis?

Research has shown that GSK1070806 may help treat moderate to severe atopic dermatitis, a type of skin condition. In earlier studies, patients who took GSK1070806 experienced significant symptom improvements compared to those who took a placebo, a harmless pill with no active medicine. These improvements appeared as early as Week 4, with more patients feeling better over time. GSK1070806 targets IL-18, a molecule involved in inflammation, which may help reduce symptoms. Overall, early findings suggest that GSK1070806 could be an effective treatment option for people with atopic dermatitis. ^{1 2 3 5 6}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. academic.oup.com academic.oup.com/bjd/article-abstract/191/Supplement_2/ljae266.052/7728590

Patient-reported outcomes for GSK1070806, an anti-IL-18 ... Patients with moderate-to-severe AD who received GSK1070806 experienced positive improvements across all PROs versus placebo.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05999799

NCT05999799 | A Dose Finding Study to Investigate the ... A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis (AtDventure).

3. s3.eu-central-1.amazonaws.com s3.eu-central-1.amazonaws.com/m-anage.com.storage.eadv/abstracts_congress2023/37031.pdf

4304 Efficacy, Safety, and Tolerability of GSK1070806, an ... This study compared the clinical effect and patient reported outcomes (PROs) of a single IV infusion of GSK1070806, a novel, first-in- class, ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-long-term-safety-of-gsk1070806-for-patients-with-moderate-to-severe-atopic-dermatitis/

Study on Long-Term Safety of GSK1070806 for Patients ... GSK1070806 is a medication being studied for its safety and effectiveness in treating moderate to severe atopic dermatitis, a skin condition that causes itchy ...

5. delta.larvol.com delta.larvol.com/Products/?ProductId=12ab9af6-64a3-4231-bea5-bc14f383e53c

GSK1070806 / GSK - Dermatitis • Dermatology A single GSK1070806 dose may benefit patients with moderate-to-severe AD as early as Week 4, with increased, clinically meaningful response rates observed at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11508724/

Very Early-Onset IBD-Associated IL-18opathy Treated with ... There are no previous efficacy or safety data regarding GSK1070806 in children. After GlaxoSmithKline (GSK) reviewed a clinical synopsis ...