Clinical trial NCT05149313: 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
Official title: A Randomised, Double-Blind, Placebo-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Lebrikizumab in Combination With Topical Corticosteroids in Adult and Adolescent Patients With Moderate-To-Severe Atopic Dermatitis That Are Not Adequately Controlled With Cyclosporine or For Whom Cyclosporine is Not Medically Advisable.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Eczema
Keywords: Topical Corticosteroids
Cyclosporine
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 331
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: At Week 16
Secondary outcomes:
measure: 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
timeFrame: At Week 16
measure: Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16
timeFrame: At Week 16
measure: 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
timeFrame: At Weeks 2, 4, 8, and12
measure: 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
timeFrame: At Weeks 2, 4, 8, 12 and 16
measure: 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
timeFrame: At Weeks 2, 4, 8, 12 and 16
measure: Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Dermatology Life Quality Index (DLQI) at Weeks 2, 4, 8, 12 and 16
timeFrame: At Weeks 2, 4, 8, 12 and 16
measure: Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Children's Dermatology Life Quality Index (CDLQI) at Weeks 2, 4, 8, 12 and 16
timeFrame: At Weeks 2, 4, 8, 12 and 16
measure: Double-blind Induction Period: Percentage of Participants Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16
timeFrame: At Week 16
measure: Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 2, 4, 8, 12 and 16
measure: Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16
timeFrame: Baseline, Weeks 8 and 16
measure: Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
timeFrame: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
measure: Double-blind Induction Period: Change From Baseline in the Sleep Loss at Week 16 Using Patient-related Outcome (PRO) by Week up to Week 16
timeFrame: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
measure: Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16
timeFrame: Baseline, Weeks 4, 8, 12 and 16
measure: Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
timeFrame: Baseline, Weeks 2, 4, 8, 12 and 16
measure: Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
timeFrame: Baseline, Weeks 2, 4, 8, 12 and 16
measure: Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
timeFrame: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16
measure: Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days
timeFrame: Baseline up to Week 16
measure: Double-blind Induction Period: Median Time (Days) to TCS-Free Use
timeFrame: Baseline up to Week 16
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Alm Site 1
city: Gent
country: Belgium
facility: Alm Site 2
city: Bordeaux
country: France
facility: Alm Site 14
city: Le Mans
country: France
facility: Alm Site 17
city: Lille
country: France
facility: Alm Site 19
city: Lille
country: France
facility: Alm Site 20
city: Martigues
country: France
facility: Alm Site 13
city: Nantes
country: France
facility: Alm Site 16
city: Nice
country: France
facility: Alm Site 15
city: Pierre-Bénite
country: France
facility: Alm Site 18
city: Reims
country: France
facility: Alm Site 12
city: Bad Bentheim
country: Germany
facility: Alm Site 28
city: Berlin
country: Germany
facility: Alm Site 30
city: Blankenfelde
country: Germany
facility: Alm Site 24
city: Bonn
country: Germany
facility: Alm Site 32
city: Frankfurt
country: Germany
facility: Alm Site 31
city: Göttingen
country: Germany
facility: Alm Site 27
city: Hamburg
country: Germany
facility: Alm Site 26
city: Kiel
country: Germany
facility: Alm Site 29
city: Marburg
country: Germany
facility: Alm Site 25
city: Bergen Op Zoom
country: Netherlands
facility: Alm Site 34
city: Rotterdam
country: Netherlands
facility: Alm Site 33
city: Utrecht
country: Netherlands
facility: Alm Site 35
city: Białystok
country: Poland
facility: Alm Site 45
city: Chorzów
country: Poland
facility: Alm Site 43
city: Katowice
country: Poland
facility: Alm Site 38
city: Kraków
country: Poland
facility: Alm Site 41
city: Kraków
country: Poland
facility: Alm Site 46
city: Lublin
country: Poland
facility: Alm Site 39
city: Ostrowiec Świętokrzyski
country: Poland
facility: Alm Site 48
city: Rzeszów
country: Poland
facility: Alm Site 44
city: Szczecin
country: Poland
facility: Alm Site 36
city: Warsaw
country: Poland
facility: Alm Site 42
city: Warszawa
country: Poland
facility: Alm Site 47
city: Wrocław
country: Poland
facility: Alm Site 40
city: Łódź
country: Poland
facility: Alm Site 37
city: Alicante
country: Spain
facility: Alm Site 10
city: Badalona
country: Spain
facility: Alm Site 3
city: Barcelona
country: Spain
facility: Alm Site 6
city: Barcelona
country: Spain
facility: Alm Site 8
city: Bilbao
country: Spain
facility: Alm Site 4
city: Madrid
country: Spain
facility: Alm Site 5
city: Mieres
country: Spain
facility: Alm Site 11
city: Sevilla
country: Spain
facility: Alm Site 7
city: Zaragoza
country: Spain
facility: Alm Site 9
city: Poole
country: United Kingdom
facility: Alm Site 23
city: Salford
country: United Kingdom
facility: Alm Site 22
city: Southampton
country: United Kingdom
facility: Alm Site 21
Study officials:
affiliation: Almirall, S.A.
name: Study Director
role: STUDY_DIRECTOR
References: