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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 below
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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:
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My body weight is less than 30 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 200
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 200 for reporting.

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 • NCT04501679
7%
Headache
5%
Dermatitis atopic
4%
Neurodermatitis
1%
Pemphigoid
1%
Dermatitis contact
1%
Pneumonia
1%
Supraventricular tachycardia
1%
Pneumococcal sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Nemolizumab

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
~2750

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
302 Previous Clinical Trials
58,987 Total Patients Enrolled
12 Trials studying Eczema
2,502 Patients Enrolled for Eczema

Media Library

Nemolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03989206 — Phase 3
Eczema Research Study Groups: Nemolizumab
Eczema Clinical Trial 2023: Nemolizumab Highlights & Side Effects. Trial Name: NCT03989206 — Phase 3
Nemolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03989206 — Phase 3
Eczema Patient Testimony for trial: Trial Name: NCT03989206 — Phase 3
~446 spots leftby Aug 2026
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