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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 200
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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?

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study
Incidence and Severity of TEAEs
Incidence of Serious TEAEs
Secondary outcome measures
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200
+16 more

Side effects data

From 2018 Phase 2 trial • 226 Patients • NCT03100344
33%
Nasopharyngitis
20%
Dermatitis atopic
13%
Headache
7%
Nausea
7%
Sinusitis
7%
Upper respiratory tract infection
5%
Diarrhoea
5%
Urinary tract infection
4%
Blood creatine phosphokinase increased
4%
Oral herpes
4%
Asthma
2%
Back pain
2%
Arthralgia
2%
Cardio-respiratory arrest
2%
Pyrexia
2%
Cough
2%
Abdominal pain
2%
Staphylococcal sepsis
2%
Asthenia
2%
Post-traumatic amnestic disorder
2%
Pneumonia aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab (10 mg)
Nemolizumab (90 mg)
Nemolizumab (30 mg)
Placebo

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
2021
Completed Phase 3
~2750

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
298 Previous Clinical Trials
58,630 Total Patients Enrolled
12 Trials studying Eczema
2,503 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical facilities are conducting this clinical trial?

"There are 100 medical sites participating in this research project. For example, Galderma Investigational Site 8506 in Hackensack, Galderma Investigational Site 8729 in Rolling Meadows, and Galderma Investigational Site 9934 in Shawnee Mission are all taking part."

Answered by AI

How many individuals are being helped by this experiment?

"Recruitment for this study has closed. The trial was initially posted on December 30th, 2019 but the most recent edit occurred on August 15th, 2022. However, there are currently 257 other studies pertaining to eczema and 10 clinical trials involving Nemolizumab that are still recruiting patients."

Answered by AI

What role has Nemolizumab played in other research projects?

"Nemolizumab was first researched in 2019 at Galderma Investigational Site 6021. So far, 5 studies have been completed with 10 more currently underway. A large number of these ongoing trials are based in Hackensack, New jersey."

Answered by AI

Are there any participants needed for this research project?

"Currently, this trial is not looking for new participants. The listing was first posted on December 30th, 2019 and edited as recently as August 15th, 2022. If you are interested in other studies, there are 257 trials actively enrolling eczema patients and 10 for Nemolizumab specifically."

Answered by AI

Is there a high risk associated with taking Nemolizumab?

"There is some evidence for efficacy and multiple rounds of data supporting safety, which gives Nemolizumab a score of 3 on our team's 1-3 scale."

Answered by AI

Have medical professionals conducted this type of study before?

"Nemolizumab was first trialed in 2019 by Galderma R&D, and has since been approved for Phase 3 use. As of now, there are 10 active global trials involving this medication taking place in 237 cities across 25 countries."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Texas
New York
Other
How old are they?
18 - 65
What site did they apply to?
Galderma Investigational Site 8866
Galderma Investigational Site 8224
Galderma Investigational Site 8825
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
2

What questions have other patients asked about this trial?

What are potential side effects?
PatientReceived no prior treatments

Why did patients apply to this trial?

I tried to know what happened in my skins and get a cure. Because my skin condition has gotten considerably worse to the pointv.
PatientReceived no prior treatments
I have been suffering for about 15 years and no topical or oral medication has helped me. Bordering desperate!
PatientReceived no prior treatments
I’m totally available. I’m retired. I’ve been deemed disabled. I can still get around. I want to make any kind of contribution to society and this is the only way I can do that at this juncture.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis
2019. "Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03989206.
All > Seborrheic Dermatitis > Atopic Dermatitis
~595 spots leftby Aug 2026
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