AzTrials
AzTrials

Atopic DermatitisPhase 4ADfindNCT06906497

Lebrikizumab in Moderate-to-severe Atopic Dermatitis

A Phase 4 study testing lebrikizumab in people with Atopic Dermatitis, run by Johann E Gudjonsson MD PhD at 4 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
lebrikizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
4 sitesin 3 countries
Study dates
2 Jul 2025to Jul 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 screening and baseline visits.
  • 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 subjects 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 least 17 weeks after the last study drug (SD) injection, when this is in line with the preferred and usual lifestyle of the subject, or to use a highly-effective and approved method of contraception throughout the study and for at least 17 weeks after the last study drug injection.
  • 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.

Who cannot join

  • 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).
Show all 25Show fewer
  • 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 > 24 hours).
  • 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 within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves.
  • 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) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment.
  • 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 cell carcinoma of the skin.
  • 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 may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments.
  • 20. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

United States2 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Physioseq USA - CA

    Folsom, California, 95630

Other trials in United States

Germany1 site

  • University of Freiburg

    Freiburg im Breisgau, 79104

Other trials in Germany

Switzerland1 site

  • Lausanne University Hospital

    Lausanne, CH-1011

Other trials in Switzerland

About this study

Official title: A Phase IV, Non-randomized, Open-label Multinational Trial to Assess the Mechanism of Action for Lebrikizumab in Moderate-to-severe Atopic Dermatitis

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.

Read the detailed description

Lebrikizumab, the drug used in the study, has been deemed IND exempt by the FDA.

Being tested
lebrikizumab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lebrikizumabDrug

    Also called Ebglyss

    Patients will receive lebrikizumab with a 500 mg loading dose administered subcutaneously at baseline and Week 2 followed by 250 mg every 2 weeks until Week 24.

    At week 24, patients with ≥ Eczema Area and Severity Index (EASI) 50 will continue in the study and begin receiving lebrikizumab 250mg every 4 weeks (Q4W), while patients with <EASI 50 will be discontinued from the study.

    At week 36, patients with EASI ≥50 to <90 will remain on Q4W through W60 (do not enter withdrawal arm), while patients with sustained low disease activity (IGA 0/1 or EASI≥90 response for at least 3 months assessed at W24 and W36) will withdraw from lebrikizumab treatment

Study groups in NCT06906497
Study groupRoleWhat they receive
Moderate-to-severe Atopic DermatitisExperimentalA total of 48 subjects with active moderate-to-severe Atopic Dermatitis (AD) will be enrolled in a 60-week study from 4 independent sites (2 US sites and 2 EU sites).
Receives: Drug: lebrikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Degree of normalization of transcriptomic/epigenetic profile

    Assessed from skin biopsies using the molecular response to lebrikizumab among patients with atopic dermatitis

    Measured: Up to week 60

Secondary outcomes (5)

  1. Molecular response to Lebrikizumab

    Assessed from skin biopsies using the molecular response to lebrikizumab among patients with atopic dermatitis, analyzed for those who discontinued treatment as well as those who continued it

    Measured: weeks 36 to 60

  2. Skin barrier function

    Assessed by serial transepidermal water loss (TEWL) measurements in lesional skin. TEWL will be measured using Courage + Khazaka gmbh tewameter hex for spot measurements

    Measured: Up to week 60

  3. Clinical response as assessed be the Eczema Area and Severity Index (EASI)

    Clinical response assessed using the EASI - Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD to be correlated with Molecular response, assessed using single-cell RNA-sequencing

    This will be done using correlation based analyses and with correction for multiple testing (FDR).

    Measured: Up to week 60

  4. Clinical response as assessed using the investigator global assessment (IGA)

    Clinical response assessed using the IGA - Score ranges from '0' = Clear to '5' = Very Severe Disease to be correlated with molecular response, assessed using single-cell RNA-sequencing.

    This will be done using correlation based analyses and with correction for multiple testing (FDR).

    Measured: Up to week 60

  5. Clinical response as assessed using the Peak Pruritus Numerical Rating Scale (NRS) (Pruitis NRS)

    Clinical response assessed using the Pruitis NRS - is a single self-report item on an 11-point scale (0 to10) where 0 is No itch, and 10 is the Worst itch imaginable. That will be correlated with the molecular response, assessed using single-cell RNA-sequencing

    This will be done using correlation based analyses and with correction for multiple testing (FDR).

    Measured: Up to week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start2 Jul 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06906497
Sponsor's protocol ID
HUM00261982
Acronym
ADfind
Status last verified
Sep 2026
First submitted
25 Mar 2025
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing lebrikizumab in people with Atopic Dermatitis, run by Johann E Gudjonsson MD PhD at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of normalization of transcriptomic/epigenetic profile (time frame: Up to week 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06906497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in