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Monoclonal Antibodies
Lebrikizumab for Eczema (ADjoin 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 for the Open-Label Addendum must be male or female adults and adolescents, have Chronic AD, Eczema Area and Severity Index (EASI) score ≥16 at baseline, Investigator Global Assessment (IGA) score ≥3 at baseline, ≥10% body surface area (BSA) of AD involvement at baseline, and history of inadequate response to treatment with topical medications or determination that topical treatments are medically inadvisable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 100
Awards & highlights
ADjoin Trial Summary
This trial will study the long-term effects of lebrikizumab on people with atopic dermatitis.
Who is the study for?
Adults and adolescents (12+ years, ≥40 kg) with chronic moderate-to-severe atopic dermatitis for over a year, who haven't responded well to topical treatments. Participants must not be pregnant or breastfeeding, agree to contraception if applicable, and have no recent live vaccines or use of certain drugs. Excludes those with serious reactions to lebrikizumab in past trials.Check my eligibility
What is being tested?
The trial is testing the long-term safety and effectiveness of Lebrikizumab in treating moderate-to-severe atopic dermatitis over a period of 110 weeks. It aims to see how well it works over time and what side effects may occur with extended use.See study design
What are the potential side effects?
Potential side effects are not detailed here but could include typical drug-related reactions such as injection site discomfort, allergic responses, immune system changes leading to increased infection risk or inflammation in various organs.
ADjoin Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic eczema, it's severe, and topical treatments haven't worked for me.
ADjoin Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 100
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 100
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 through the Last Treatment Visit
Secondary outcome measures
Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) from Baseline of Parent Study
Percentage of Participants with a Response of Investigator Global Assessment (IGA) Score 0 or 1
Side 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%
Conjunctival disorder
1%
Endophthalmitis
1%
Tinea cruris
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
ADjoin Trial Design
7Treatment groups
Experimental Treatment
Group I: Lebrikizumab Q8W (Open-Label Extension Addendum)Experimental Treatment1 Intervention
Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q8W by SC injection.
Group II: Lebrikizumab Q4W (Open-Label Extension Addendum)Experimental Treatment1 Intervention
Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q4W by SC injection.
Group III: Lebrikizumab Q4WExperimental Treatment1 Intervention
Participants assigned to lebrikizumab Q4W (once every 4 weeks) arm will receive investigational product Q4W by SC injection.
Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.
Group IV: Lebrikizumab Q2W (Open-Label) from Parent StudyExperimental Treatment1 Intervention
Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.
Group V: Lebrikizumab Q2W (Open-Label Extension Addendum)Experimental Treatment1 Intervention
Participants enrolling in Open-Label extension addendum will receive lebrikizumab Q2W by SC injection.
Group VI: Lebrikizumab Q2W (Open-Label Addendum)Experimental Treatment1 Intervention
Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.
Group VII: Lebrikizumab Q2W (Blinded) from Parent StudyExperimental Treatment1 Intervention
Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.
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?
Dermira, Inc.Industry Sponsor
16 Previous Clinical Trials
4,883 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,199,741 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,064 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Topical treatments have not worked for me or are not suitable due to medical reasons.I haven't taken any biologic treatments for at least 8 weeks or 5 half-lives, whichever is longer.I don't have hepatitis, HIV, cancer in the last 5 years, or certain medical conditions.I have never taken lebrikizumab or had a severe allergic reaction.I have not used certain immune drugs, had phototherapy, or received live vaccines recently.I agree to avoid pregnancy during and for 18 weeks after my treatment.I agree to use birth control or abstain from sex during and for 18 weeks after my treatment.I have chronic eczema, it's severe, and topical treatments haven't worked for me.I have not had a serious reaction to lebrikizumab in a previous study.I have a chronic disease that often requires oral steroids, like severe asthma.I have received light therapy for my skin condition.I have not received a live vaccine in the last 12 weeks and do not plan to during the study.You have used a tanning booth/parlor more than twice a week in the last 4 weeks before the study starts.I have had chronic atopic dermatitis for over a year.Your skin condition is rated as moderate or severe by the study doctor.I haven't taken B cell-depleting drugs like rituximab in the last 6 months.At least 10% of my skin is affected by my condition.You have a score of 16 or higher on the Eczema Area and Severity Index (EASI) test at the beginning of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Lebrikizumab Q4W
- Group 2: Lebrikizumab Q4W (Open-Label Extension Addendum)
- Group 3: Lebrikizumab Q8W (Open-Label Extension Addendum)
- Group 4: Lebrikizumab Q2W (Open-Label Extension Addendum)
- Group 5: Lebrikizumab Q2W (Open-Label) from Parent Study
- Group 6: Lebrikizumab Q2W (Open-Label Addendum)
- Group 7: Lebrikizumab Q2W (Blinded) from Parent Study
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT04392154 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does the current research say about Lebrikizumab?
"There are three Lebrikizumab trials ongoing, with the majority of them being Phase 3 studies. The location for most of these trials is Nantes, Loira Atlantico; however, there are 474 other research centres around the world conducting similar investigations."
Answered by AI
How many people will be included in this trial?
"The total number of participants required for the trial to run smoothly is 1000. Dermira, Inc., the sponsor company, will be managing the study from locations like Acclaim Dermatology in Sugar Land, Texas and Texas Dermatology and Laser Specialists in San Antonio."
Answered by AI
Has Lebrikizumab been cleared by the FDA?
"There is both efficacy and safety data available for Lebrikizumab, which our team has rated a 3 on a scale of 1 to 3."
Answered by AI
Are there any positions available in this trial for new participants?
"Yes, this is an ongoing trial that is presently recruiting patients. The original posting was on 6/15/2020 and the last update was on 11/10/2022. They are looking for a total of 1000 patients from 100 different sites."
Answered by AI
Is this research project happening at a lot of different hospitals in America?
"Currently, this trial is being conducted at 100 sites. While some of these are in major cities like Sugar Land, San Antonio and Beverly, others are more rural. If you enroll in the trial, it's important to try and choose a location that is close to you to limit travel as much as possible."
Answered by AI
Does this clinical trial break new ground?
"At this time, there are 3 ongoing clinical trials for lebrikizumab in 23 countries and 248 cities. The first study was sponsored by Dermira, Inc. in 2020 and completed its Phase 3 drug approval stage with 1000 participants. There have been a total of 23 completed studies since then."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Arizona
Other
New York
How old are they?
< 18
18 - 65
What site did they apply to?
The University of Florida Health System
Acevedo Clinical Research Associates
Modern Research Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
Why did patients apply to this trial?
I tried so many drugs and nothing has worked long term. I have tried over 2 dozen topicals and oral steroids but have received no relief. I have been suffering for more than 10 years.
PatientReceived 1 prior treatment
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