Lebrikizumab for Atopic Dermatitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Atopic DermatitisLebrikizumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: Baseline, Week 24

Baseline to Week 16
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >75% Reduction in EASI Score
Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline Who Achieve at least 4-point Reduction
Percentage of Participants with an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points from Baseline
Baseline to Week 24
Percentage of Participants Achieving EASI-75
Percentage of Participants Achieving EASI-90 from Baseline
Percentage of Participants with a Pruritus NRS of ≥3 points at Baseline Who Achieve at least 3-point Reduction
Percentage of Participants with a Pruritus NRS of ≥4 points at Baseline Who Achieve at least 4-point Reduction
Percentage of Participants with a Sleep-Loss Scale of ≥2 points at Baseline Who Achieve at least 2-point Reduction
Percentage of Participants with an IGA Score of 0 or 1 and a Reduction ≥2 Points from Baseline
Baseline, Week 16
Change from Baseline in Children's Dermatology Life Quality Index (cDLQI)
Change from Baseline in Dermatology Life Quality Index (DLQI)
Percentage Change from Baseline in SCORing Atopic Dermatitis (SCORAD)
Baseline, Week 24
Change from Baseline in DLQI
Change from Baseline in EASI
Change from Baseline in Skin Pain NRS
Change from Baseline in Sleep-Loss Scale
Change from Baseline in cDLQI
Percentage Change from Baseline in EASI
Percentage Change from Baseline in Pruritus NRS Score
Percentage Change from Baseline in SCORAD

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Induction - Lebrikizumab 250mg Q2W
7%Conjunctivitis
6%Dermatitis atopic
4%Nasopharyngitis
3%Oral herpes
3%Headache
2%Conjunctivitis allergic
2%Covid-19
2%Dysmenorrhoea
1%Back pain
1%Folliculitis
1%Asthma
1%Fatigue
1%Rhinitis allergic
1%Depression
1%Heavy menstrual bleeding
1%Blepharitis
1%Gastroenteritis
1%Impetigo
1%Pruritus
1%Oedema peripheral
1%Bacterial vaginosis
1%Chalazion
1%Bronchitis
1%Injection site erythema
1%Thrombocytopenia
1%Eye irritation
1%Seborrhoeic dermatitis
1%Gastroenteritis viral
1%Vulvovaginal candidiasis
1%Arthralgia
1%Dizziness
1%Anxiety
1%Hypertension
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT04146363) in the Induction - Lebrikizumab 250mg Q2W ARM group. Side effects include: Conjunctivitis with 7%, Dermatitis atopic with 6%, Nasopharyngitis with 4%, Oral herpes with 3%, Headache with 3%.

Trial Design

1 Treatment Group

Lebrikizumab
1 of 1

Experimental Treatment

120 Total Participants · 1 Treatment Group

Primary Treatment: Lebrikizumab · No Placebo Group · Phase 3

Lebrikizumab
Drug
Experimental Group · 1 Intervention: Lebrikizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lebrikizumab
2014
Completed Phase 3
~6220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 24

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,466 Previous Clinical Trials
3,135,282 Total Patients Enrolled
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
1,258 Previous Clinical Trials
369,278 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have chronic AD that has been present for at least 1 year before screening.
You have a score of 3 or higher on the IGA scale at baseline.
You have EASI ≥16 at baseline.
You have ≥10% BSA of AD involvement at baseline.