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New treatment option for Atopic Dermatitis
Official title Lebrikizumab in Moderate-to-severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT06906497
What this study is testing
What is lebrikizumab?
lebrikizumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atopic dermatitis.
Also referred to as Ebglyss.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is studying a drug already approved for the treatment of atopic dermatitis (AD). This research collects health-related information and blood and skin samples to understand if the study drug, lebrikizumab, leads to long-term improvement in AD skin.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Established diagnosis of AD for at least 1 year before the screening visit and topical treatment was inadequate or inadvisable.
- Moderate-to-severe AD with involvement \> 10% of body-surface-area (BSA) and investigator global assessment (IGA) score =3 (based on the IGA scale...
- Subject has an Eczema Area and Severity Index (EASI) score =16 at screening and baseline.
- Subject has a pruritus NRS =4.
- Subject is biologic naïve.
You likely can't join if
- Previous treatment with lebrikizumab or participation in a lebrikizumab study.
- History of anaphylaxis as defined by the Sampson criteria.
- Treatment with topical corticosteroids, calcineurin inhibitors, Jak inhibitors, or crisaborole within 1 week prior to the baseline visit.
- Prior treatment with dupilumab or tralokinumab.
- Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-., Janus kinase inhibitors (JAKi)...
See the full eligibility criteria
- Established diagnosis of AD for at least 1 year before the screening visit and topical treatment was inadequate or inadvisable.
- Moderate-to-severe AD with involvement \> 10% of body-surface-area (BSA) and investigator global assessment (IGA) score =3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the...
- Subject has an Eczema Area and Severity Index (EASI) score =16 at screening and baseline.
- Subject has a pruritus NRS =4.
- Subject is biologic naïve.
- Female people of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for at...
- Subject willing and able to comply with all of the clinical study protocol's time commitments and procedural requirements.
- Understand and sign an informed consent form (ICF) (and assent form, when applicable) before any investigational procedure(s) are performed.
- Previous treatment with lebrikizumab or participation in a lebrikizumab study.
- History of anaphylaxis as defined by the Sampson criteria.
- Treatment with topical corticosteroids, calcineurin inhibitors, Jak inhibitors, or crisaborole within 1 week prior to the baseline visit.
- Prior treatment with dupilumab or tralokinumab.
- Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-., Janus kinase inhibitors (JAKi), azathioprine, methotrexate).
- Phototherapy and photochemotherapy (PUVA) for AD.
- Treatment with the following prior to the baseline visit:
- An investigational drug within 8 weeks or 5 half-lives (if known), whichever is longer.
- Cell-depleting biologics, including to rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- Use of prescription moisturizers within 7 days of the baseline visit.
- Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for \>...
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, anti-parasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections...
- Evidence of active acute or chronic hepatitis (as defined by the Department of Health \& Human Services Centers for Disease Control and Prevention) or known liver cirrhosis.
- Diagnosed active endoparasitic infections or at high risk of these infections.
- Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis)...
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- In the Investigator's opinion, any clinically significant laboratory results from the chemistry, hematology or urinalysis tests available in the medical history.
- Presence of skin comorbidities that may interfere with study assessments.
- History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal...
- Severe concomitant illness(es) that in the Investigator's judgment would adversely affect the patient's participation in the study. Any other medical or psychological condition that in the opinion of the Investigator...
The study team makes the final eligibility decision.
Where it's taking place
- Folsom, California, United States
- Ann Arbor, Michigan, United States
- Freiburg im Breisgau, Germany
- Lausanne, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Folsom, California, United States; Ann Arbor, Michigan, United States; Freiburg im Breisgau, Germany; Lausanne, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.