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Phase 3 N=331 Randomized Quadruple-blind Treatment

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

Dermatitis, Atopic · Eczema

Enrolled (actual)
331
Serious AEs
3.1%
Results posted
Nov 2024
Primary outcome: Primary: 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 — 68.4; 40.8 Percentage of participants — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Lebrikizumab (Biological); Lebrikizumab-matching Placebo (Drug)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
Almirall, S.A.
Primary completion
Jan 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
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
68.4; 40.8 <0.0001 sig
SECONDARY
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
42.0; 24.5 0.0052 sig
SECONDARY
Double-blind Induction Period: Percentage of Participants Who Achieved a 4-point Improvement in Pruritus Numeric Rating Score (NRS) at Week 16
49.9; 29.7 0.0114 sig
SECONDARY
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
9.7; 6.3; 28.3; 19.2; 54.9; 31.5
SECONDARY
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
1.5; 0.9; 15.8; 6.4; 28.9; 10.6
SECONDARY
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
30.8; 23.4; 58.9; 46.0; 75.2; 59.3
SECONDARY
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
52.8; 57.1; 66.1; 61.9; 70.5; 56.1
SECONDARY
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
90.9; 100; 68.2; 62.5; 90.9; 100
SECONDARY
Double-blind Induction Period: Percentage of Participants Who Achieved a 4- Point Improvement in Skin Pain NRS at Week 16
51.6; 27.5
SECONDARY
Double-blind Induction Period: Change From Baseline in Body Surface Area (BSA) at Weeks 2, 4, 8, 12 and 16
-11.4; -10.6; -19.5; -15.3; -27.3; -19.2
SECONDARY
Double-blind Induction Period: Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at Weeks 8 and 16
-32.1; -20.0; -36.8; -23.7
SECONDARY
Double-blind Induction Period: Change From Baseline in Pruritus NRS by Week up to Week 16
-1.543; -1.113; -2.199; -1.420; -2.351; -1.450
SECONDARY
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
-0.603; -0.493; -0.816; -0.673; -0.875; -0.577
SECONDARY
Double-blind Induction Period: Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Weeks 4, 8, 12 and 16
-8.4; -4.7; -10.9; -5.2; -11.3; -5.1
SECONDARY
Double-blind Induction Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 2. 4, 8, 12 and 16
-4.6; -4.5; -7.1; -5.4; -8.3; -5.7
SECONDARY
Double-blind Induction Period: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2. 4, 8, 12 and 16
-2.9; -3.6; -5.1; -4.3; -6.6; -6.9
SECONDARY
Double-blind Induction Period: Change From Baseline in Skin Pain NRS by Week up to Week 16
-1.546; -0.905; -2.152; -1.316; -2.308; -1.271
SECONDARY
Double-blind Induction Period: Proportion of Topical Corticosteroids (TCS) Medication Free Days
0.224; 0.151
SECONDARY
Double-blind Induction Period: Median Time (Days) to TCS-Free Use
NA; NA

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 =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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05149313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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