Your session is about to expire
← Back to Search
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 • NCT0414636313%
Covid-19
10%
Nasopharyngitis
6%
Dermatitis atopic
5%
Conjunctivitis allergic
4%
Benign prostatic hyperplasia
3%
Aspartate aminotransferase increased
3%
Sinusitis
3%
Contusion
3%
Vulvovaginal candidiasis
3%
Oral herpes
3%
Headache
2%
Ligament sprain
2%
Osteoarthritis
2%
Micturition disorder
2%
Vaccination complication
2%
Alopecia
2%
Back pain
2%
Eyelid irritation
2%
Tooth infection
2%
Alanine aminotransferase increased
2%
Somatic symptom disorder
2%
Eyelid oedema
2%
Cholecystitis
2%
Impetigo
2%
Hepatic steatosis
2%
Food allergy
2%
Postoperative wound infection
2%
Overdose
2%
Myalgia
2%
Cough
2%
Solar lentigo
2%
Sunburn
2%
Otitis media
2%
Upper respiratory tract infection
2%
Blood lactate dehydrogenase increased
2%
Pruritus
2%
Urticaria
2%
Conjunctivitis
2%
Herpes dermatitis
2%
Urinary tract infection
2%
Weight increased
2%
Sciatica
2%
Erythema
2%
Papule
2%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Maintenance Blinded - Placebo Responder/ Placebo
Maintenance Blinded - Placebo Responder/ Lebrikizumab Q2W
Maintenance Blinded - Lebrikizumab Responder/Lebrikizumab Q4W
Escape Arm Week 16 - Maintenance OL- Lebrikizumab Non-Responder/Lebrikizumab Q2W
Maintenance Blinded - Placebo Responder/Lebrikizumab Q4W
Escape Arm Week 16 - Maintenance Open Label (OL) -Placebo Non-Responder/Lebrikizumab Q2W
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
~6750
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
2,624 Previous Clinical Trials
3,215,733 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,349 Previous Clinical Trials
414,492 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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger