Eczema (Atopic Dermatitis)
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Eczema (Atopic Dermatitis)
219538 Enrolling

Biologic & Topical-Alternative Eczema Trial (32 Weeks)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults 18-75 with eczema, also known as atopic dermatitis (AD).

Inclusion Criteria

  • Clinical diagnosis of moderate or severe AD for at least 1 year
  • Body surface area (BSA) involvement of AD of 10% or more*
  • Have stopped a biologic treatment (due to non-response, partial response, loss of efficacy, intolerance, cost, or lack of access) OR
  • Have had inadequate response to prescription topical medications in the past 6 months, or for whom they are not tolerated or are medically inadviseable

* 1% of your body surface area is roughly equal to the palm of your hand (no wrists or fingers).

What Are The Benefits?

  • No cost to participate or receive study treatment
  • Regular visits with study doctors who specialise in treating AD (16 visits)
  • Will receive either an investigative subcutaneous injection treatment (study drug) or a placebo
  • Reimbursement for study-related expenses may be provided

How Long Will The Study Last?

  • 32 weeks

Participating Locations

Participating Experts

Dr. Maryam Shayesteh Alam

Dermatologist

Dr. Wei Jing Loo

Dermatologist

Dr. Charles Lynde

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: May 19, 2024

Official Title

A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC Injection in Adult Participants With Moderate to Severe Atopic Dermatitis

ClinicalTrials.gov ID

NCT05999799

Sponsor

GlaxoSmithKline

Study Description

  • Brief Summary:

    This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.

  • Condition or Disease:

    Dermatitis, Atopic

  • Intervention/Treatment:

    Drug: GSK1070806
    Drug: GSK1070806
    Drug: GSK1070806
    Drug: GSK1070806
    Drug: Placebo
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

Adult participants 18 years to 75 years of age

Participants with:

AtD defined by the AAD Consensus Criteria.
Diagnosis of AtD ≥1 year.
An IGA score ≥3.
AtD involvement of ≥10% body surface area (BSA).
EASI score ≥16
Baseline pruritus numerical rating scale average score for maximum intensity of at least 3.

Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions:

Participants who stopped treatment due to non-response, partial response, loss of efficacy.
Participants who stopped treatment due to intolerance or AEs.
Participants who stopped treatment due to cost or loss of access.
Participant with a recent history less than or equal to (≤6) months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication.
Participants for whom prescription topical medications are not tolerated.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical study

Exclusion Criteria:

Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits.
Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed)
Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit.
Symptomatic herpes zoster within 3 months prior to screening
Uncontrolled hypertension.
Current or chronic history of liver disease or known hepatic or biliary abnormalities.
Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution or unusually frequent, recurrent, or prolonged infections, per the Investigator’s judgment.
Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Breast cancer within the past 10 years.
History or presence of significant medical illness including but not limited to cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological, or psychiatric disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
Previously treated with any oral Janus Kinase inhibitor (JAKi) or other kinase inhibitors, experimental or approved.
Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma.
Presence of Hepatitis B surface antibody (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
Positive HIV antibody test.
Evidence of active or latent TB as documented by medical history, examination, and TB testing with a positive QuantiFERON test at initial Screening visit.
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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