A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine

NCT05149313 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M-17923-302021-002967-23
• Study Type: interventional
• Target: 331
• Locations: 8 countries
• Sites: 48

Brief Summary

The main purpose of this study is to evaluate the efficacy of lebrikizumab compared with placebo in participants not adequately controlled with cyclosporine or for whom cyclosporine is not medically advisable up to Week 16.

Conditions

Dermatitis, Atopic; Eczema

Keywords

Topical Corticosteroids; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Double-blind Induction Period: Percentage of Participants Who Achieved Eczema Area and Severity Index (EASI) 75 (>=75% Reduction From Baseline in EASI Score) at Week 16

  The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. The severity of the clinical signs of AD for each of 4 body regions was scored on a 4-point scale: 0=absent, 1=mild, 2=moderate and 3=severe. The area of AD involvement on each of the 4 anatomic regions was assessed as a percentage by body area: 0=no eruption, 1=1% to 9%, 2=10% to 29%, 3=30% to 49%, 4=50% to 60%, 5=70% to 80% and 6=90% to 100%. The composite index with total score ranged from 0 to 72, where higher scores indicates more severe and or extensive disease.

  At Week 16

Secondary Outcomes (18)

• Double-blind Induction Period: Percentage of Participants Who Achieved Investigator Global Assessment (IGA) Score of 0 or 1 and 2-point Improvement at Week 16

  At Week 16

• Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16

  At Week 16

• Double-blind Induction Period: Percentage of Participants Who Achieved EASI 75 (>=75% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, and 12

  At Weeks 2, 4, 8, and12

• Double-blind Induction Period: Percentage of Participants Who Achieved EASI 90 (>=90% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16

  At Weeks 2, 4, 8, 12 and 16

• Double-blind Induction Period: Percentage of Participants Who Achieved EASI 50 (>=50% Reduction From Baseline in EASI Score) at Weeks 2, 4, 8, 12 and 16

  At Weeks 2, 4, 8, 12 and 16

Study Arms (2)

Lebrikizumab

EXPERIMENTAL

Lebrikizumab administered subcutaneously (SC), participants will receive 2 injections of lebrikizumab 250 mg at Baseline and Week 2, followed by 1 injection of lebrikizumab 250 milligram (mg) once every two weeks (Q2W) in the induction period up to week 16. Participants who received lebrikizumab 250 mg Q2W during the Induction Period will continue to receive lebrikizumab 250 mg Q2W during the Maintenance Period. In order to maintain the double blind, participants from the lebrikizumab 250 mg Q2W arm will be administered a second injection of blinded placebo during Week 16 and Week 18. From Week 20 up to Week 52, all participants will receive 1 injection of lebrikizumab 250 mg Q2W in Open-label maintenance period.

Biological: Lebrikizumab

Lebrikizumab-matching Placebo

PLACEBO COMPARATOR

Lebrikizumab-matching Placebo administered SC, 250 mg dose, Q2W in the induction period for 16 weeks. Participants will receive 2 injections of lebrikizumab 250 mg at Week 16 and Week 18 followed by 1 injection of lebrikizumab 250 mg Q2W from Week 20 up to Week 52 in Open-label maintenance period.

Drug: Lebrikizumab-matching Placebo

Interventions

Lebrikizumab BIOLOGICAL

Lebrikizumab solution for injection administered subcutaneously.

Lebrikizumab

Lebrikizumab-matching Placebo DRUG

Matching Placebo solution for injection administered subcutaneously.

Lebrikizumab-matching Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults and adolescents (aged greater than or equal to (\>=) 12 to \<18 years at the time of Informed Consent Form (ICF)/Informed Assent Form (IAF) and weighing \>=40 kilograms).
• Chronic AD that has been present for \>=1 year before the Screening visit.
• EASI score \>=16 at the Baseline Visit.
• IGA score \>=3 (moderate) (scale of 0 \[clear\] to 4 \[severe\]) at the Baseline visit.
• \>=10% BSA of AD involvement at the Baseline visit.
• Inadequate response to existing topical medications
• Failure to cyclosporine or non-medically advisable to receive/continue receiving cyclosporine
• Signed ICF (and informed assent for adolescents as required)

You may not qualify if:

• Treatment with TCS within 1 week before the Baseline visit.
• Treatment with topical calcineurin inhibitors, phosphodiesterase-4 inhibitors such as crisaborole, or cannabinoids within 2 week before the Baseline visit.
• Treatment with interleukin 4 (IL-4) or interleukin 13 (IL-13) antagonists biological therapies before the Baseline visit. Exception: previous treatment with dupilumab will be allowed in a subset of patients
• Treatment with immunosuppressive/immunomodulating drugs, phototherapy and photochemotherapy within 4 weeks before the Baseline visit
• Uncontrolled chronic disease that might require bursts of oral corticosteroids
• Serious, opportunistic, chronic or recurring infections within 3 months of Screening or before randomization
• Current or chronic infection with hepatitis B virus, current infection with hepatitis C virus, known liver cirrhosis and/or chronic hepatitis of any etiology
• Known or suspected history of immunosuppression, history of HIV infection or positive HIV serology at Screening
• Any clinically significant laboratory test results obtained at the Screening visit
• Presence of skin comorbidities that may interfere with study assessments
• Have had an important side effect to TCS that would prevent further use.

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (48)

Alm Site 1

Graz, Austria

Location

Alm Site 2

Ghent, Belgium

Location

Alm Site 14

Bordeaux, France

Location

Alm Site 17

Le Mans, France

Location

Alm Site 19

Lille, France

Location

Alm Site 20

Lille, France

Location

Alm Site 13

Martigues, France

Location

Alm Site 16

Nantes, France

Location

Alm Site 15

Nice, France

Location

Alm Site 18

Pierre-Bénite, France

Location

Alm Site 12

Reims, France

Location

Alm Site 28

Bad Bentheim, Germany

Location

Alm Site 30

Berlin, Germany

Location

Alm Site 24

Blankenfelde, Germany

Location

Alm Site 32

Bonn, Germany

Location

Alm Site 31

Frankfurt, Germany

Location

Alm Site 27

Göttingen, Germany

Location

Alm Site 26

Hamburg, Germany

Location

Alm Site 29

Kiel, Germany

Location

Alm Site 25

Marburg, Germany

Location

Alm Site 34

Bergen op Zoom, Netherlands

Location

Alm Site 33

Rotterdam, Netherlands

Location

Alm Site 35

Utrecht, Netherlands

Location

Alm Site 45

Bialystok, Poland

Location

Alm Site 43

Chorzów, Poland

Location

Alm Site 38

Katowice, Poland

Location

Alm Site 41

Krakow, Poland

Location

Alm Site 46

Krakow, Poland

Location

Alm Site 37

Lodz, Poland

Location

Alm Site 39

Lublin, Poland

Location

Alm Site 48

Ostrowiec Świętokrzyski, Poland

Location

Alm Site 44

Rzeszów, Poland

Location

Alm Site 36

Szczecin, Poland

Location

Alm Site 42

Warsaw, Poland

Location

Alm Site 47

Warsaw, Poland

Location

Alm Site 40

Wroclaw, Poland

Location

Alm Site 10

Alicante, Spain

Location

Alm Site 3

Badalona, Spain

Location

Alm Site 6

Barcelona, Spain

Location

Alm Site 8

Barcelona, Spain

Location

Alm Site 4

Bilbao, Spain

Location

Alm Site 5

Madrid, Spain

Location

Alm Site 11

Mieres, Spain

Location

Alm Site 7

Seville, Spain

Location

Alm Site 9

Zaragoza, Spain

Location

Alm Site 23

Poole, United Kingdom

Location

Alm Site 22

Salford, United Kingdom

Location

Alm Site 21

Southampton, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

lebrikizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Head of Global Clinical Development
• Organization: Almirall S.A

gco@almirall.com

+34932913000

Study Officials

• Study Director

  Almirall, S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 8, 2021
• Study Start: December 23, 2021
• Primary Completion: January 30, 2023
• Study Completion: May 7, 2024
• Last Updated: May 20, 2025
• Results First Posted: November 6, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9); AU (1); PL (13); ES (9); BE (1); DE (9); GB (3); NL (3)