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Lebrikizumab for Eczema (ADjoin Trial)
ADjoin Trial Summary
This trial will study the long-term effects of lebrikizumab on people with atopic dermatitis.
ADjoin Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADjoin Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 424 Patients • NCT04146363ADjoin Trial Design
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- 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.
- 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
- 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.
- 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
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."
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."
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."
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."
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."
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."
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