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
NCT ID: NCT05149313
Last Updated: 2025-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
331 participants
INTERVENTIONAL
2021-12-23
2024-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lebrikizumab
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.
Lebrikizumab
Lebrikizumab solution for injection administered subcutaneously.
Lebrikizumab-matching Placebo
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.
Lebrikizumab-matching Placebo
Matching Placebo solution for injection administered subcutaneously.
Interventions
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Lebrikizumab
Lebrikizumab solution for injection administered subcutaneously.
Lebrikizumab-matching Placebo
Matching Placebo solution for injection administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
12 Years
ALL
No
Sponsors
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Almirall, S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Almirall, S.A.
Locations
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Alm Site 1
Graz, , Austria
Alm Site 2
Ghent, , Belgium
Alm Site 14
Bordeaux, , France
Alm Site 17
Le Mans, , France
Alm Site 19
Lille, , France
Alm Site 20
Lille, , France
Alm Site 13
Martigues, , France
Alm Site 16
Nantes, , France
Alm Site 15
Nice, , France
Alm Site 18
Pierre-Bénite, , France
Alm Site 12
Reims, , France
Alm Site 28
Bad Bentheim, , Germany
Alm Site 30
Berlin, , Germany
Alm Site 24
Blankenfelde, , Germany
Alm Site 32
Bonn, , Germany
Alm Site 31
Frankfurt, , Germany
Alm Site 27
Göttingen, , Germany
Alm Site 26
Hamburg, , Germany
Alm Site 29
Kiel, , Germany
Alm Site 25
Marburg, , Germany
Alm Site 34
Bergen op Zoom, , Netherlands
Alm Site 33
Rotterdam, , Netherlands
Alm Site 35
Utrecht, , Netherlands
Alm Site 45
Bialystok, , Poland
Alm Site 43
Chorzów, , Poland
Alm Site 38
Katowice, , Poland
Alm Site 41
Krakow, , Poland
Alm Site 46
Krakow, , Poland
Alm Site 37
Lodz, , Poland
Alm Site 39
Lublin, , Poland
Alm Site 48
Ostrowiec Świętokrzyski, , Poland
Alm Site 44
Rzeszów, , Poland
Alm Site 36
Szczecin, , Poland
Alm Site 42
Warsaw, , Poland
Alm Site 47
Warsaw, , Poland
Alm Site 40
Wroclaw, , Poland
Alm Site 10
Alicante, , Spain
Alm Site 3
Badalona, , Spain
Alm Site 6
Barcelona, , Spain
Alm Site 8
Barcelona, , Spain
Alm Site 4
Bilbao, , Spain
Alm Site 5
Madrid, , Spain
Alm Site 11
Mieres, , Spain
Alm Site 7
Seville, , Spain
Alm Site 9
Zaragoza, , Spain
Alm Site 23
Poole, , United Kingdom
Alm Site 22
Salford, , United Kingdom
Alm Site 21
Southampton, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-002967-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M-17923-30
Identifier Type: -
Identifier Source: org_study_id
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