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Monoclonal Antibodies

Lebrikizumab for Eczema (ADmirable Trial)

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adolescents body weight must be ≥40 kg at baseline.
Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights

ADmirable Trial Summary

This trialtests a drug to treat atopic dermatitis, a common skin condition, in teens and adults, especially in people with skin of color.

Who is the study for?
This trial is for adults and adolescents (12 years and older) with moderate-to-severe atopic dermatitis, specifically those with skin of color (Fitzpatrick phototype IV-VI). Participants should have a history of inadequate response to topical treatments. Women must use effective contraception or remain abstinent, while men's requirements vary by location.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Lebrikizumab in treating atopic dermatitis among individuals with darker skin tones. It aims to see if this medication can improve their condition when other treatments haven't worked well enough.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions similar to other medications for atopic dermatitis such as redness, itching or burning at the injection site, headache, cold symptoms, eye inflammation and possible immune system effects.

ADmirable Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is at least 40 kg.
Select...
Topical treatments have not worked for me or are not suitable due to my condition.
Select...
I am not required to use contraception unless mandated by local laws for the study.
Select...
I agree to use effective birth control or abstain from sex during and for 18 weeks after treatment.
Select...
At least 10% of my skin is affected by my condition.
Select...
I am 12 years old or older and can consent to participate.
Select...
My chronic condition has lasted for more than a year.

ADmirable Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% reduction from baseline in EASI)
Secondary outcome measures
Change from Baseline in Children's Dermatology Life Quality Index (cDLQI)
Change from Baseline in DLQI
Change from Baseline in Dermatology Life Quality Index (DLQI)
+17 more

Side effects data

From 2022 Phase 3 trial • 424 Patients • NCT04146363
5%
Conjunctivitis allergic
5%
Conjunctivitis
4%
Asthma
4%
Dermatitis atopic
4%
Nasopharyngitis
4%
Headache
3%
Depression
3%
Eosinophilia
3%
Rhinitis allergic
2%
Acne
2%
Dysmenorrhoea
2%
Ocular hyperaemia
2%
Dry eye
2%
Covid-19
2%
Vaginal haemorrhage
2%
Herpes dermatitis
2%
Tooth abscess
2%
Penile squamous cell carcinoma
1%
Injection site reaction
1%
Tinea cruris
1%
Radius fracture
1%
Respiratory tract infection viral
1%
Thermal burn
1%
Endophthalmitis
1%
Sleep disorder
1%
Angle closure glaucoma
1%
Arthritis
1%
Neutropenia
1%
Conjunctival disorder
1%
Protein urine present
1%
Deafness unilateral
1%
Vomiting
1%
Procedural pain
1%
Urine bilirubin increased
1%
Cellulitis
1%
Eye pain
1%
Epistaxis
1%
Contusion
1%
Blood phosphorus decreased
1%
Ingrowing nail
1%
Strongyloides test positive
1%
Neck pain
1%
Dyspnoea
1%
Haemoglobin urine present
1%
Labyrinthitis
1%
Eosinophil count increased
1%
Pertussis
1%
Pelvic fracture
1%
Delirium
1%
Glaucomatocyclitic crises
1%
Constipation
1%
Blood uric acid increased
1%
Thrombocytopenia
1%
Pyrexia
1%
Herpes simplex
1%
Periarthritis
1%
Galactorrhoea
1%
Lacrimation increased
1%
Lymphopenia
1%
Vertigo
1%
Oral herpes
1%
Upper limb fracture
1%
Nitrite urine present
1%
Urine leukocyte esterase positive
1%
Hypercholesterolaemia
1%
Obesity
1%
Histiocytic necrotising lymphadenitis
1%
Migraine
1%
Blepharitis
1%
Tonsillitis
1%
Upper respiratory tract infection
1%
Urinary tract infection
1%
Vaccination complication
1%
Essential tremor
1%
Reflux laryngitis
1%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Blinded - Placebo Responder/ Placebo
Maintenance Blinded - Placebo Responder/ Lebrikizumab Q2W
Escape Arm Week 16 - Maintenance OL- Lebrikizumab Non-Responder/Lebrikizumab Q2W
Escape Arm Week 16 - Maintenance Open Label (OL) -Placebo Non-Responder/Lebrikizumab Q2W
Maintenance Blinded - Placebo Responder/Lebrikizumab Q4W
Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q4W
Induction - Placebo
Maintenance Blinded - Lebrikizumab Responder/ Placebo
Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q2W
Escape Arm Week 24 to 48 - Maintenance Lebrikizumab
Induction - Lebrikizumab 250mg Q2W

ADmirable Trial Design

1Treatment groups
Experimental Treatment
Group I: LebrikizumabExperimental Treatment1 Intervention
Participants will receive Lebrikizumab subcutaneously (SC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lebrikizumab
2014
Completed Phase 3
~6420

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,352 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
403,727 Total Patients Enrolled
Study DirectorEli Lilly and Company

Media Library

Lebrikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05372419 — Phase 3
Atopic Dermatitis Research Study Groups: Lebrikizumab
Atopic Dermatitis Clinical Trial 2023: Lebrikizumab Highlights & Side Effects. Trial Name: NCT05372419 — Phase 3
Lebrikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05372419 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree does Lebrikizumab present a risk to individuals?

"The safety of Lebrikizumab is rated a 3, indicating that there has been preceding evidence to demonstrate its efficacy and multiple evaluations in favor of the drug's security."

Answered by AI

Does this research endeavor currently accept new enrollees?

"Investigation of clinicaltrials.gov reveals that this medical trial is not enrolling patients at the current moment, having been posted on December 15th 2022 and last updated on December 7th 2022. Fortunately, there are an additional 237 studies currently recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Dermatology Research Associates
San Francisco Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
~0 spots leftby Mar 2024