GSK1070806 for Eczema (AtDvance Trial)

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

Be older than 18 years old

Must not have

Use of systemic therapy considered contraindicated for AtD.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16, 32, 48 and up to week 280 (eos)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to assess how safe and effective GSK1070806 is in treating moderate to severe atopic dermatitis in participants who have already completed a previous study for the same condition.

Who is the study for?

This trial is for individuals with moderate to severe atopic dermatitis who completed the Phase 2 study (NCT05999799) and may benefit from further treatment. Participants must be able to attend clinic visits, use electronic devices for questionnaires, and women of childbearing potential must follow strict contraceptive guidelines and have negative pregnancy tests.

What is being tested?

The long-term safety and effectiveness of GSK1070806 are being tested in patients with atopic dermatitis who previously participated in a related Phase 2b study. The goal is to see how well this drug works over an extended period.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse events that arise during the course of treatment with GSK1070806, especially those that led to discontinuation in earlier phases.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

Systemic therapy is not suitable for my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16, 32, 48 and up to week 280 (eos)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16, 32, 48 and up to week 280 (eos)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16, 32, 48 and up to week 280 (eos) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with AE leading to discontinuation of GSK1070806

Number of participants with Adverse event (AE)

Number of participants with Serious adverse event (SAE)

+1 more

Secondary study objectives

Number of Participants Achieving Investigators Global Assessment (IGA) score of 0 or 1 at Week 16, 32, 48 and up to Week 280 (EoS)

Number of participants Achieving Eczema Area and Severity Index (EASI) reduction of greater than or equal to (>=) 75 percent (%) at Week 16, 32, 48 and up to Week 280 (EoS)

Number of participants with decreased Peak Pruritus Numerical Rating Scale (PP-NRS) by >=4 points at Week 16, 32, 48 and up to Week 280 (EoS)

+3 more