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Monoclonal Antibodies
Nemolizumab for Eczema
Phase 3
Waitlist Available
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
Key
Must not have
Body weight < 30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 200
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing the long-term safety and effectiveness of the drug nemolizumab in people with moderate to severe atopic dermatitis.
Who is the study for?
This trial is for individuals with moderate-to-severe atopic dermatitis who have previously participated in a nemolizumab study and may benefit from further treatment. Women of childbearing age must commit to abstinence or approved contraception during the study and for 12 weeks after. Exclusions include those with adverse reactions to previous nemolizumab use, current infections, recent COVID-19 infection, pregnancy, breastfeeding, or planning pregnancy.
What is being tested?
The trial is assessing the long-term safety and effectiveness of Nemolizumab in treating moderate-to-severe atopic dermatitis (eczema). It's designed for participants who've been part of prior studies on this medication to continue observing its impacts over an extended period.
What are the potential side effects?
Potential side effects of Nemolizumab can include allergic reactions like anaphylaxis, especially in those with a history of hypersensitivity to immunoglobulin products. Other risks might involve injection site reactions or immune system-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to avoid pregnancy during and for 12 weeks after the study by being abstinent or using birth control.
Select...
It seems like the criterion you've mentioned is incomplete. Could you please provide more details or context so I can assist you better?
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My body weight is less than 30 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 200
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 200
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit
Side effects data
From 2022 Phase 3 trial • 274 Patients • NCT045016797%
Headache
5%
Dermatitis atopic
4%
Neurodermatitis
1%
Dermatitis contact
1%
Pneumonia
1%
Supraventricular tachycardia
1%
Pneumococcal sepsis
1%
Pemphigoid
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab
Placebo
Awards & Highlights
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: NemolizumabExperimental Treatment1 Intervention
Nemolizumab administered via subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2022
Completed Phase 3
~2980
Find a Location
Who is running the clinical trial?
Galderma R&DLead Sponsor
302 Previous Clinical Trials
58,960 Total Patients Enrolled
12 Trials studying Eczema
2,503 Patients Enrolled for Eczema
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a severe allergic reaction to a medication made from blood or genetically engineered proteins, like monoclonal antibodies.You have previously participated in a study for a medication called nemolizumab for atopic dermatitis and may benefit from participating in this study.I agree to avoid pregnancy during and for 12 weeks after the study by being abstinent or using birth control.My body weight is less than 30 kg.I haven't had any skin infections, needed antibiotics, or had COVID-19 in the last 2 weeks.It seems like the criterion you've mentioned is incomplete. Could you please provide more details or context so I can assist you better?I agree to avoid pregnancy during the study and for 12 weeks after the last dose.If you were in a previous study with nemolizumab and had a bad reaction that could make it risky for you to continue taking the medication, you cannot participate.
Research Study Groups:
This trial has the following groups:- Group 1: Nemolizumab
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.
Eczema Patient Testimony for trial: Trial Name: NCT03989206 — Phase 3