ADfind

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Michigan

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Decision date (initial)

2025-08-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Almirall and Dermira

External identifiers

EU CT number

2025-521833-97-00

ClinicalTrials.gov

NCT06906497

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic

Determine the kinetics and maintenance of the molecular response and epigenetic changes of treatment with lebrikizumab in moderate-to-severe AD to increase understanding of clinical responses, including durable long-term improvements in the skin.

Conditions and MedDRA coding

Moderate-to-severe atopic dermatitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Male or Female subjects aged ≥ 18 years at the screening visit.
2. 2. Established diagnosis of AD for at least 1 year before the screening visit and topical treatment was inadequate or inadvisable.
3. 3. 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.
4. 4. Subject has an Eczema Area and Severity Index (EASI) score ≥ 16 at screening and baseline.
5. 5. Subject has a pruritus NRS ≥ 4.
6. 6. Subject is biologic naïve.
7. 7. 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.
8. 8. Subject willing and able to comply with all of the clinical study protocol's time commitments and procedural requirements.
9. 9. Understand and sign an informed consent form (ICF) (and assent form, when applicable) before any investigational procedure(s) are performed.

Exclusion criteria 20

1. 1. Previous treatment with lebrikizumab or participation in a lebrikizumab study.
2. 2. History of anaphylaxis as defined by the Sampson criteria.
3. 3. Treatment with topical corticosteroids, calcineurin inhibitors, Jak inhibitors, or crisaborole within 1 week prior to the baseline visit.
4. 4. Prior treatment with dupilumab or tralokinumab.
5. 5. Treatment with any of the following agents within 4 weeks prior to the baseline visit: a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors (JAKi), azathioprine, methotrexate). b. Phototherapy and photochemotherapy (PUVA) for AD.
6. 6. Treatment with the following prior to the baseline visit: a. An investigational drug within 8 weeks or 5 half-lives (if known), whichever is longer. b. Cell-depleting biologics, including to rituximab, within 6 months. c. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
7. 7. Use of prescription moisturizers within 7 days of the baseline visit.
8. 8. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
9. 9. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
10. 10. 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).
11. 11. Active chronic or acute infection (including Helminth infections) 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.
12. 12. 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.
13. 13. Diagnosed active endoparasitic infections or at high risk of these infections.
14. 14. 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.
15. 15. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
16. 16. In the Investigator’s opinion, any clinically significant laboratory results from the chemistry, hematology or urinalysis tests available in the medical history.
17. 17. Presence of skin comorbidities that may interfere with study assessments.
18. 18. 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.
19. 19. 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. 20. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Degree of normalization of transcriptomic and epigenetic profile in skin biopsies from baseline over time, measuring molecular changes after treatment with lebrikizumab

Secondary endpoints 6

1. 1. Molecular (transcriptomic/epigenetic) response to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60.
2. 2. Molecular (transcriptomic/epigenetic) change to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60.
3. 3. Molecular (transcriptomic/epigenetic) response after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm.
4. 4. Molecular (transcriptomic/epigenetic) changes after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm.
5. 5. Improvement in skin barrier function as assessed by serial TEWL measurements in lesional skin from baseline to week 60 in all subjects.
6. 6. Correlation between clinical response (EASI/IGA and Pruitis NRS) with molecular (transcriptomic/epigenetic) at weeks 2, 24, 36, and 60.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Michigan

Sponsor organisation

University Of Michigan

Address

1301 Catherine Street Rm 6447 Ms 1

City

Ann Arbor

Postcode

48109-2026

Country

United States

Scientific contact point

Organisation

University Of Michigan

Contact name

Johann Gudjonsson, MD, PhD

Public contact point

Organisation

University Of Michigan

Contact name

Johann Gudjonsson, MD, PhD

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications