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Monoclonal Antibodies

Lebrikizumab for Atopic Dermatitis

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

Study Summary

This trial will test whether lebrikizumab can improve the effectiveness of a vaccine in people with atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 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 Who Develop a Booster Response to Tetanus Toxoid 4 Weeks After Tdap (Tetanus-diphtheria-pertussis) Vaccine Administration
Percentage of Participants Who Have Positive Antibody Response to Meningococcus C Antigen 4 Weeks After Meningococcal Conjugate Vaccine (MCV) Administration
Secondary outcome measures
Change From Baseline in Percent Body Surface Area (BSA)
Change From Baseline in Sleep-Loss Score
Percentage of Participants Achieving a ≥75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI-75)
+3 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%
Dysmenorrhoea
2%
Acne
2%
Ocular hyperaemia
2%
Dry eye
2%
Covid-19
2%
Vaginal haemorrhage
2%
Herpes dermatitis
2%
Tooth abscess
2%
Penile squamous cell carcinoma
1%
Angle closure glaucoma
1%
Tinea cruris
1%
Endophthalmitis
1%
Respiratory tract infection viral
1%
Conjunctival disorder
1%
Radius fracture
1%
Injection site reaction
1%
Sleep 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/ Placebo
Escape Arm Week 16 - Maintenance OL- Lebrikizumab Non-Responder/Lebrikizumab Q2W
Maintenance Blinded - Placebo 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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LebrikizumabExperimental Treatment1 Intervention
Participants received a loading dose of 500 milligram (mg) lebrikizumab injection administered subcutaneously (SC) at baseline and week 2, and 250 mg once every two weeks (Q2W) from week 4 to 14.
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo SC injection Q2W from baseline to week 14.
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
2,618 Previous Clinical Trials
3,201,306 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,500 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
LA Universal Research Center, INC
Recent research and studies
clinicaltrials.govStudy
A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)
2020. "A Study of Lebrikizumab (LY3650150) on Vaccine Response in Adults With Atopic Dermatitis (ADopt-VA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04626297.
~58 spots leftby Apr 2025
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