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Monoclonal Antibodies

Lebrikizumab 250 mg for Atopic Dermatitis (ADore Trial)

Phase 3
Waitlist Available
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

ADore Trial Summary

This trial will study the safety and effectiveness of the drug lebrikizumab in treating moderate to severe atopic dermatitis in adolescents. The trial will last for 52 weeks.

Eligible Conditions
  • Atopic Dermatitis

ADore Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 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 Discontinued From Study Treatment Due to Adverse Events (AEs)
Secondary outcome measures
Change From Baseline in Body Surface Area (BSA)
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
Change From Baseline in Dermatology Life Quality Index (DLQI)
+8 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%
Tinea cruris
1%
Respiratory tract infection viral
1%
Radius fracture
1%
Endophthalmitis
1%
Angle closure glaucoma
1%
Injection site reaction
1%
Sleep disorder
1%
Conjunctival disorder
1%
Arthritis
1%
Haemoglobin urine present
1%
Protein urine present
1%
Thermal burn
1%
Neutropenia
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%
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/ Lebrikizumab Q2W
Maintenance Blinded - Placebo Responder/ Placebo
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

ADore Trial Design

1Treatment groups
Experimental Treatment
Group I: Lebrikizumab 250 mgExperimental Treatment1 Intervention
Participants received two subcutaneous (SC) injections of 250 milligram(mg) Lebrikizumab at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 up to (but not including) Week 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lebrikizumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,610 Previous Clinical Trials
3,200,221 Total Patients Enrolled
Dermira, Inc.Industry Sponsor
16 Previous Clinical Trials
5,865 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,342 Previous Clinical Trials
404,544 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
2020. "Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04250350.
~40 spots leftby Apr 2025
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