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Monoclonal Antibodies
Lebrikizumab for Eczema (ADapt 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
Participants must have prior treatment with dupilumab meeting specific conditions
Participants must have ≥10% body surface area (BSA) of AD involvement at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
ADapt Trial Summary
This trialwill study a new drug for people with severe eczema who have already used Dupilumab.
Who is the study for?
Adults and adolescents with moderate-to-severe atopic dermatitis (AD) who previously used Dupilumab but stopped due to intolerance, adverse events, cost issues, or lack of efficacy. They must have had AD for over a year, an IGA score of ≥3, EASI score ≥16, and at least 10% body surface area affected. Adolescents must weigh ≥40 kg. Exclusions include HIV infection, uncontrolled asthma requiring steroids recently, liver disease like cirrhosis/hepatitis, recent use of certain AD treatments including Dupilumab.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Lebrikizumab in those who've had previous treatment with Dupilumab without success or could not tolerate it. The goal is to see if Lebrikizumab can improve symptoms in patients with moderate-to-severe AD.See study design
What are the potential side effects?
While specific side effects for Lebrikizumab are not listed here, common side effects for medications treating atopic dermatitis may include injection site reactions, eye problems like redness or itching (conjunctivitis), headaches and cold sores.
ADapt Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been treated with dupilumab under certain conditions.
Select...
At least 10% of my skin is affected by my condition.
Select...
I weigh at least 40 kg.
Select...
Topical treatments have not worked for me or are not suitable due to my health.
ADapt Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
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 in EASI Score
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 moreSide effects data
From 2022 Phase 3 trial • 424 Patients • NCT041463635%
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%
Respiratory tract infection viral
1%
Angle closure glaucoma
1%
Tinea cruris
1%
Conjunctival disorder
1%
Endophthalmitis
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
ADapt Trial Design
1Treatment groups
Experimental Treatment
Group I: LebrikizumabExperimental Treatment1 Intervention
Participants will receive Lebrikizumab by subcutaneous (SC) injection.
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
2,613 Previous Clinical Trials
3,200,809 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have a hepatitis C virus (HCV) infection.I frequently need oral steroids for a chronic condition.My asthma has been severe, needing steroids or hospital stays in the last year.I stopped using dupilumab after 4 months due to it not working well enough.I stopped taking dupilumab because it caused side effects or I couldn't tolerate it.I have been treated with dupilumab under certain conditions.I have had chronic atopic dermatitis for at least 1 year.I haven't used any skin creams for my condition in the last 2 weeks.I have had chronic atopic dermatitis for at least 1 year.Your Eczema Area and Severity Index (EASI) score is 16 or higher at the beginning of the study.At least 10% of my skin is affected by my condition.I have liver cirrhosis or chronic hepatitis.I have not taken Dupilumab in the last 4 weeks.I haven't taken any immune system affecting drugs for my condition in the last 4 weeks.I have been treated with tralokinumab before.Your IGA score must be 3 or higher at the beginning of the study.I have HIV or tested positive for HIV.I weigh at least 40 kg.I stopped taking dupilumab because it was too expensive or I lost access.You have a current or long-lasting hepatitis B virus (HBV) infection.Topical treatments have not worked for me or are not suitable due to my health.Your IGA score is 3 or higher at the start of the study.Your EASI score needs to be 16 or higher at the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Lebrikizumab
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Lebrikizumab a safe and viable treatment option for patients?
"Previous research has demonstrated the efficacy and safety of lebrikizumab, so it is assigned a rating of 3 on our organization's scale."
Answered by AI
How many locales are currently offering this experiment?
"To participate in this trial, patients can visit any of the 16 participating medical centres such as Medical Dermatology Specialists in Phoenix, First OC Dermatology in Fountain Valley, and Skin care Physicians of Georgia. Additionally, there are 13 other locations available for enrolment."
Answered by AI
Does the research team have available slots for participants?
"This experiment, as indicated by clinicaltrials.gov, is not presently open to recruitment. Initially announced on November 30th 2022 and most recently updated seven days later, the trial has yet to resume enrollment; however 237 other studies are actively recruiting patients at this time."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
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