GSK1070806 for Atopic Dermatitis

No longer 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

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 chronic skin condition causing itchy, inflamed skin. The researchers aim to determine if the drug is safe and effective compared to a placebo, which is a harmless, inactive treatment. Participants will receive either a single dose of the treatment or a placebo through an IV. This trial suits those who have experienced atopic dermatitis symptoms for at least six months and have not responded well to previous treatments, including certain topical creams or the medication dupilumab. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

Previous studies have generally shown that GSK1070806 is well tolerated. Research indicates that the most common side effect was nasopharyngitis, a medical term for a sore throat or runny nose. These studies, which included both healthy and overweight participants, reported no serious safety concerns. This suggests the treatment might be safe for humans. However, more research is needed to confirm its safety for treating atopic dermatitis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for atopic dermatitis focus on reducing inflammation and calming the immune system, often using topical steroids or calcineurin inhibitors. However, GSK1070806 is unique because it targets the interleukin-33 (IL-33) pathway, a different part of the immune system linked to skin inflammation. This mechanism of action sets it apart from standard treatments, potentially offering a new way to manage symptoms. Researchers are excited because this novel approach could lead to more effective relief for patients who don't respond well to current options. Additionally, GSK1070806 is administered as an intravenous infusion, which might provide rapid onset of action compared to traditional topical applications.

What evidence suggests that this trial's treatments could be effective for atopic dermatitis?

Research has shown that GSK1070806, which participants in this trial may receive, might help treat moderate to severe atopic dermatitis. In studies, patients who took GSK1070806 noticed improvements compared to those who received a placebo. This suggests the drug could help reduce symptoms like itching and skin irritation. GSK1070806 works by blocking interleukin-18 (IL-18), a protein that can cause inflammation. By doing this, the drug aims to reduce inflammation and improve skin health. While more research is needed, early results are promising for people with atopic dermatitis. ^{6 7 8 9 10}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• GSK1070806
• Placebo

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33684160/

A pilot study evaluating GSK1070806 inhibition of ... Results: GSK1070806 administration was associated with IL18-GSK1070806 complex detection and increased total serum IL18 levels due to IL18 ...

2. 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.

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. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0247972

A pilot study evaluating GSK1070806 inhibition of interleukin ... This phase IIa, single-arm trial assessed the effect of a single dose of GSK1070806 on DGF occurrence post donation after circulatory death (DCD) kidney ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26930607/

A Study to Investigate the Efficacy and Safety of an Anti ... Conclusions: GSK1070806 was well tolerated, and inhibition of IL-18 did not lead to any improvements in glucose control. However, because of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01648153

Investigate the Efficacy and Safety of GSK1070806 in ... The aims of this placebo controlled study are to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1070806 in obese ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25109413/

18 mAb GSK1070806 in healthy and obese subjects Blood was sampled ≤ 274 days post-dosing, and safety monitored. Results: GSK1070806 was generally well tolerated. The most common AEs were nasopharyngitis and ...

8. medchemexpress.com medchemexpress.com/gsk-1070806.html?srsltid=AfmBOorvkZTOMN84snwtbtDWDy4pLoGO3TMXEPZcR5QleqxUazmf-s13

GSK-1070806 (Aletekitug) | IL-18 Antibody GSK-1070806. Inquiry Online. Your information is safe with us. ... SAFETY DATA SHEET (SDS). English - EN (251 KB) Français - FR (251 KB) Deutsch ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01035645

First Time in Human Study of Intravenous Interleukin-18 ... The main purpose of this study is to test GSK1070806 in healthy and obese male subjects with normal immune systems to find out how safe this drug is.

10. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0150018

A Study to Investigate the Efficacy and Safety of an Anti ... Preliminary efficacy, safety and tolerability, pharmacokinetics, and pharmacodynamics of the anti-IL-18 monoclonal antibody, GSK1070806, were assessed.