A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis.

Eli Lilly and Company89 sites in 3 countries445 target enrollmentOctober 29, 2019

ConditionsAtopic Dermatitis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Atopic Dermatitis
Sponsor: Eli Lilly and Company
Enrollment: 445
Locations: 89
Primary Endpoint: Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration. The study is designed to confirm the safety and efficacy of lebrikizumab as monotherapy for treatment of moderate-to-severe atopic dermatitis utilizing a 16-week induction treatment period and a 36-week long-term maintenance treatment period.

Registry

clinicaltrials.gov

Start Date

October 29, 2019

End Date

April 28, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female adults and adolescents (≥12 years and ≥40 kg)
•Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit
•Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit
•Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
•≥10% body surface area (BSA) of atopic dermatitis involvement at the baseline visit
•History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable

Exclusion Criteria

•Prior treatment with dupilumab or tralokinumab
•Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to the baseline visit
•Treatment with any of the following agents within 4 weeks prior to the baseline visit:
•Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
•Phototherapy and photochemotherapy (PUVA) for AD
•Treatment with the following prior to the baseline visit:
•An investigational drug within 8 weeks or within 5 half-lives (if known) of baseline, whichever is longer
•Cell-depleting biologics, including to rituximab, within 6 months of baseline
•Other biologics within 5 half-lives (if known) or 16 weeks of baseline, whichever is longer
•Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study

Outcomes

Primary Outcomes

Percentage of Participants Achieving Eczema Area And Severity Index (EASI-75) (≥75% Reduction in EASI Score) From Baseline to Week 16

Time Frame: Baseline to Week 16

The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score.

Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16

Time Frame: Baseline to Week 16

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Secondary Outcomes

Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 2(Baseline to Week 2)
Percentage Change in EASI Score From Baseline to Week 16(Baseline, Week 16)
Percentage of Participants With a Pruritus NRS Score of ≥4-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16(Baseline to Week 16)
Percentage of Participants With a Pruritus NRS Score of ≥5-points at Baseline Who Achieve a ≥4-point Reduction in Pruritus NRS Score From Baseline to Week 16(Baseline to Week 16)
Change From Baseline in Sleep-loss Score at Week 16(Baseline, Week 16)
Percentage of Participants With a Sleep-loss Score ≥2 Points at Baseline Who Achieve a ≥2 Points Reduction From Baseline to Week 16(Baseline to Week 16)
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1(Baseline to Week 1)
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2(Baseline to Week 2)
Percentage of Participants From Those With a Pruritus NRS of ≥4-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52(Baseline to Week 52)
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 4(Baseline to Week 4)
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16(Baseline to Week 16)
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16(Baseline to Week 16)
Percentage Change in Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16(Baseline, Week 16)
Change From Baseline in Percent Body Surface Area (BSA) at Week 16(Baseline, Week 16)
Percentage of Participants Achieving EASI-90 From Baseline to Week 4(Baseline to Week 4)
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16(Baseline, Week 16)
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 1(Baseline to Week 1)
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 2(Baseline to Week 2)
Percentage Change in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16(Baseline, Week 16)
Percentage of Participants Achieving ≥4-point Improvement in DLQI From Baseline to Week 16(Baseline to Week 16)
Percentage of Participants With a DLQI Total Score of ≥4-point at Baseline Achieving ≥4-point Improvement in DLQI From Baseline to Week 16(Baseline to Week 16)
Percentage Change in Sleep-loss Score From Baseline to Week 16(Baseline, Week 16)
Percentage of Participants With a Pruritus NRS Score of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4(Baseline to Week 4)
Percentage of Participants With a Pruritus NRS Score of ≥5 Points at Baseline Who Achieve a ≥4-point Reduction From Baseline to Week 4(Baseline to Week 4)
Pharmacokinetics (PK): Trough Serum Concentrations of Lebrikizumab in Maintenance Period (C-trough)(Predose at Week 52)
Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16(Baseline, Week 16)
Change From Baseline in PROMIS Anxiety at Week 16 - Adults(Baseline, Week 16)
Percentage of Participants From Those Re-randomized Having Achieved EASI-75 at Week 16 Who Continue to Exhibit EASI-75 at Week 52 (EASI-75 Calculated Relative to Baseline EASI Score)(Baseline to Week 52)
Percentage of Participants From Those Re-randomized Having Achieved IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 16 Who Continue to Exhibit an IGA 0 or 1 and a ≥2-point Improvement From Baseline at Week 52(Baseline to Week 52)
Percentage of Participants From Those With a Pruritus NRS of ≥5-points at Baseline Re-randomized Having Achieved ≥4-point Reduction From Baseline at Week 16 Who Continue to Exhibit ≥4-point Reduction From Baseline at Week 52(Baseline to Week 52)
Percentage Change in SCORAD (From Those Re-randomized Having Achieved EASI-75 at Week 16) From Baseline at Week 52(Baseline, Week 52)
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 16 - Health State Index(Baseline, Week 16)
Change From Baseline in EQ-5D-5L at Week 16 - Visual Analog Scale (VAS)(Baseline, Week 16)
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16-Adolescents(Baseline, Week 16)
Change From Baseline in PROMIS Depression at Week 16- Adolescents(Baseline, Week 16)
Change From Baseline in PROMIS Depression at Week 16- Adults(Baseline, Week 16)
Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 16 in Participants Who Have Self-reported Comorbid Asthma(Baseline, Week 16)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16(Baseline, Week 16)