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Monoclonal Antibodies

GSK1070806 for Atopic Dermatitis

Phase 2

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baseline pruritus numerical rating scale average score for maximum intensity of at least 3.

AtD involvement of ≥10% body surface area (BSA).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 28

Awards & highlights

Study Summary

This trial studies an Atopic Dermatitis drug for safety, effectiveness, and how it works in the body.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects of GSK1070806 aren't listed here, but common ones for new treatments in AD may include skin reactions at the treatment site, infections, headaches, nausea, and potential systemic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience itching at a severity of at least 3 out of 10.

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My skin condition affects 10% or more of my body.

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I am between 18 and 75 years old.

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I stopped my treatment because it wasn't working well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent Change from Baseline (PCFB) in the Eczema Area and Severity Index (EASI) at Week 16

Secondary outcome measures

Change From Baseline in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) (International Units per Litre)

Change from Baseline in Clinical Chemistry Parameter: Total Bilirubin (Micromoles per Litre)

Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Gamma-Glutamyl Transferase (GGT), and Alkaline Phosphatase (AP) (Units per Litre)

+21 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GSK1070806

2022

Completed Phase 2

~200

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,650 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,755 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability to join this investigation?

"According to information posted on clinicaltrials.gov, this research endeavour is currently enrolling volunteers. It was initially launched November 15th 2023 and underwent edits as of the 30th of that same month."

Answered by AI

What is the current enrollment in this experiment?

"Affirmative. According to the data from clinicaltrials.gov, this investigation is actively recruiting patients at present time. It was initially posted on November 15th 2023 and modified recently on November 30th of the same year. 175 individuals are required for recruitment across 82 medical sites."

Answered by AI

Has the Food and Drug Administration authorized GSK1070806 Dose 1 for public consumption?

"Based on our team's assessment, GSK1070806 Dose 1 was given a safety rating of 2. As this is currently in Phase 2 trials, there has been some evidence indicating its security but not efficacy yet."

Answered by AI

Does the eligibility criteria for this clinical trial include adults over 20?

"According to the inclusion criteria, potential participants of this trial should be aged 18-75. For those that are younger than 18 years old or older than 65, there are 86 and 161 studies respectively available for them."

Answered by AI

How many medical institutions are currently conducting this research study?

"At the moment, 82 different medical centres are recruiting participants for this trial. While Santa Monica, Pompano Beach and North Little Rock serve as some of these sites, there are many other places across America to choose from. To limit travel expenses during your involvement in this study, it is wise to select a clinic closest to you."

Answered by AI

Could I qualify to join this medical experiment?

"This medical trial seeks 175 individuals, aged 18 to 75, who have been diagnosed with atopic dermatitis for a year or more and display symptoms of itchiness (with an average numerical rating scale score of 3) as well as AtD-affected area covering ≥10% body surface. Additionally, participants must have either stopped treatment due to non-response/partial response/loss of efficacy/intolerance or adverse effects OR cost issues; their IGA score must be equal or above 3 while EASI should reach 16 points minimum."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis

2023. "A Dose Finding Study to Investigate the Safety and Effectiveness of GSK1070806 in Adult Participants With Moderate to Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05999799.

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