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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16
Awards & highlights

Study Summary

This trial is testing a new drug for people with moderate to severe eczema that hasn't been helped by other treatments.

Eligible Conditions
  • Eczema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects with EASI-75
Proportion of subjects with an IGA success (IGA of 0 or 1) and a ≥ 2-point reduction
Secondary outcome measures
Proportion of subjects with EASI-75 and improvement of PP NRS ≥ 4
Proportion of subjects with IGA success and improvement of PP NRS ≥ 4
Proportion of subjects with PP NRS < 2
+2 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%
Cough
2%
Back pain
2%
Arthralgia
2%
Cardio-respiratory arrest
2%
Pyrexia
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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NemolizumabExperimental Treatment1 Intervention
Nemolizumab administered via subcutaneous injection
Group II: PlaceboPlacebo Group1 Intervention
Placebo 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
299 Previous Clinical Trials
59,632 Total Patients Enrolled
12 Trials studying Eczema
3,415 Patients Enrolled for Eczema

Frequently Asked Questions

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

Could you explain how many individuals are being enrolled in this clinical trial at this time?

"This trial is no longer actively looking for patients. The study was initially posted on 6/30/2019 and was last updated on 8/15/2022. However, there are currently 255 studies actively searching for patients with eczema and 10 trials for Nemolizumab actively recruiting participants."

Answered by AI

Has the FDA given their stamp of approval to Nemolizumab?

"Nemolizumab's safety is estimated to be a 3. This is because there are multiple rounds of data that support the safety of this medication and some data that suggests it is efficacious."

Answered by AI

Are there numerous test sites for this trial in Canada?

"This study is still looking for participants and has 55 different enrolment centres. Hialeah, Miami and Columbus each have a recruitment location, in addition to the other 52 locations. If you are interested in enrolling, try to choose a centre close to you to limit travel."

Answered by AI

Could you please summarize the Nemolizumab research that has been conducted to date?

"There are presently 10 active clinical trials involving nemolizumab, with 7 in Phase 3. Nemolizumab trials are being conducted all over the world, with 1161 total locations."

Answered by AI

Have researchers conducted this type of experiment before?

"Nemolizumab has been under research and development since 2019. Galderma R&D conducted the first clinical trial that year. Following the successful first study with 750 participants, the medication received approval for Phase 3 trials. Currently, there are 10 ongoing Nemolizumab trials happening in 237 cities and 25 different countries."

Answered by AI

Who else is applying?

What state do they live in?
Utah
California
New York
Other
How old are they?
18 - 65
What site did they apply to?
Galderma Investigational Site 8683
Galderma Investigational Site 8821
Galderma Investigational Site 8807
Other
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
2019. "Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03989349.
~137 spots leftby Apr 2025
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