NCT05990725

Brief Summary

The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe atopic dermatitis (AD).

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2023

Geographic Reach
3 countries

33 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

August 7, 2023

Last Update Submit

April 22, 2025

Conditions

Atopic DermatitisEczema

Keywords

DermatitisSkin Diseases

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score Less Than or Equal to (<=) 7 at Week 24

    The EASI is used to assess the severity and extent of AD; it is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and or extensive disease. The severity of erythema, induration/papulation, excoriation, and lichenification will be assessed by the Investigator or trained designee on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. In addition, the extent of AD involvement in each of the 4 body areas will be assessed as a percentage by body area of head/neck, trunk, upper limbs, and lower limbs, and converted to a score of 0 (0%), 1 (0 to 9%), 2 (10 to 29%), 3 (30 to 49%), 4 (50 to 69%), 5 (70 to 89%) and 6 (90 to 100%).

    At Week 24

Secondary Outcomes (13)

  • Percentage of Participants Achieving EASI Score <=7, EASI <=5, and EASI <=3

    Baseline up to Week 24

  • Percentage of Participants Achieving EASI 75 and EASI 90

    Baseline up to Week 24

  • Percentage of Participants with an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction Greater Than or Equal to (>=2) Points

    Baseline up to Week 24

  • Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) 75 and SCORAD 90

    Baseline up to Week 24

  • Percentage Change From Baseline in Modified Total Lesion Symptom Score (mTLSS)

    Baseline up to Week 24

  • +8 more secondary outcomes

Study Arms (1)

Lebrikizumab

EXPERIMENTAL

Participants will receive loading doses of lebrikizumab 500 milligrams (mg) subcutaneous (SC) injection at Day 1 and Week 2 followed by lebrikizumab 250 mg SC injection, every two weeks (Q2W) from Week 4 to Week 16. At Week 16, the dosing frequency will be reduced to every 4 weeks (Q4W) and will receive lebrikizumab 250 mg SC injection for up to Week 24, last dose of study medication is administered at Week 20.

Biological: Lebrikizumab

Interventions

LebrikizumabBIOLOGICAL

Lebrikizumab solution for injection administered subcutaneously.

Lebrikizumab

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adults and adolescents (aged \>=12 to less than \[\<\] 18 years at the time of informed consent form (ICF)/informed assent form (IAF) signature and weighing \>=40 kg) who are candidates for systemic AD therapy.
  • Chronic AD that has been present for \>=1 year before the Screening visit.
  • EASI score \>=12 at the Day 1/Baseline Visit.
  • IGA score \>=3 (moderate) (scale of 0 \[clear\] to 4 \[severe\]) at the Baseline visit.
  • \>=10% BSA of AD involvement at the Day 1/Baseline visit.
  • History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
  • Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4 of 7 days before Day 1/Baseline.
  • Willing and able to comply with all clinic visits and study-related procedures and questionnaires.
  • For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or to use a highly effective contraceptive method during the treatment period and for at least 4 weeks or 1 menstrual period after the last dose of lebrikizumab.
  • Participant must provide signed ICF. Adolescent participants must also provide separate informed assent to enroll in the study and sign and date either a separate IAF or the ICF signed by the parent/legal guardian (as appropriate based on local regulations and requirements).

You may not qualify if:

  • Prior treatment at any time with tralokinumab, lebrikizumab, or an oral JAK inhibitor.
  • Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to undergo the required washout period for a particular prohibited medication.
  • History of anaphylaxis as defined by the Sampson criteria.
  • Uncontrolled chronic disease that might require bursts of oral corticosteroids, example, co-morbid severe uncontrolled asthma (defined by an Asthma Control Questionnaire-5 score \>=1.5 or a history of \>=2 asthma exacerbations within the last 12 months requiring systemic \[oral and/or parenteral\] corticosteroid treatment or hospitalisation for \>24 hours).
  • Occurrence of the following types of infection within 3 months of Screening or develop any of these infections before Day 1/Baseline:
  • Serious (requiring hospitalisation, and/or IV or equivalent oral antibiotic treatment, as per the Investigator's opinion);
  • Opportunistic
  • Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer);
  • Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis).
  • Known current or chronic infection with hepatitis B virus.
  • Known liver cirrhosis and/or chronic hepatitis of any aetiology.
  • Known active endoparasitic infections or at high risk of these infections.
  • Known or suspected history of immunosuppression, including history of invasive opportunistic infections (example, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgement.
  • History of human immunodeficiency virus (HIV) infection or known positive HIV serology.
  • Any clinically significant laboratory test results from the chemistry or haematology tests obtained at the Screening visit that would jeopardise the patient's participation in the study, per the Investigator's judgement.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Site 34

Augsburg, Germany

Location

Site 9

Berlin, Germany

Location

Site 29

Bonn, Germany

Location

Site 27

Dresden, Germany

Location

Site 28

Düsseldorf, Germany

Location

Site 11

Erlangen, Germany

Location

Site 37

Frankfurt, Germany

Location

Site 32

Freiburg im Breisgau, Germany

Location

Site 5

Göttingen, Germany

Location

Site 15

Hamburg, Germany

Location

Site 3

Hamburg, Germany

Location

Site 8

Hamburg, Germany

Location

Site 23

Heidelberg, Germany

Location

Site 1

Kiel, Germany

Location

Site 19

Langenau, Germany

Location

Site 10

Lübeck, Germany

Location

Site 26

Mainz, Germany

Location

Site 6

Mannheim, Germany

Location

Site 36

Marburg, Germany

Location

Site 13

München, Germany

Location

Site 17

München, Germany

Location

Site 33

München, Germany

Location

Site 4

Münster, Germany

Location

Site 12

Oberhausen, Germany

Location

Site 22

Oldenburg, Germany

Location

Site 2

Potsdam, Germany

Location

Site 30

Regensburg, Germany

Location

Site 7

Rostock, Germany

Location

Site 18

Tübingen, Germany

Location

Site 35

Bergen op Zoom, Netherlands

Location

Site 41

Utrecht, Netherlands

Location

Site 38

Leeds, United Kingdom

Location

Site 14

York, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczemaDermatitisSkin Diseases

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 14, 2023

Study Start

November 20, 2023

Primary Completion

June 23, 2025

Study Completion

June 23, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(29)NL(2)GB(2)