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Monoclonal Antibodies

Nemolizumab for Atopic Dermatitis

Phase 2
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
Chronic AD for at least 2 years
EASI score >= 16
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 (4 weeks post-vaccination)
Awards & highlights

Study Summary

This trial will test whether a new medication can help improve the effectiveness of vaccinations for people with moderate-to-severe atopic dermatitis.

Eligible Conditions
  • Atopic Dermatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had eczema for at least 2 years.
Select...
You have a skin condition with a score of 16 or higher on the Eczema Area and Severity Index.
Select...
You experience severe itching with a score of at least 4 out of 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 (4 weeks post-vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 (4 weeks post-vaccination) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with a Positive Serum Immunoglobulin G (IgG) Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)
Secondary outcome measures
Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16
Percentage of Participants with Serum Aanti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16
Percentage of Participants with a Positive SBA Response to Meningococcal Serogroup C Polysaccharide at Week 16
+2 more

Side effects data

From 2018 Phase 2 trial • 226 Patients • NCT03100344
28%
Dermatitis atopic
23%
Nasopharyngitis
18%
Asthma
9%
Headache
7%
Upper respiratory tract infection
7%
Gastroenteritis
5%
Oral herpes
5%
Pyrexia
4%
Back pain
4%
Cough
2%
Diarrhoea
2%
Urinary tract infection
2%
Blood creatine phosphokinase increased
2%
Rhinitis
2%
Nausea
2%
Septic shock
2%
Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab (90 mg)
Nemolizumab (10 mg)
Nemolizumab (30 mg)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NemolizumabExperimental Treatment1 Intervention
Participants will receive a loading dose of nemolizumab (60 milligram [mg]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) will then be administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a placebo via 2 SC injections at baseline. Placebo will then be administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2021
Completed Phase 3
~2500

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
295 Previous Clinical Trials
59,967 Total Patients Enrolled

Media Library

Nemolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04365387 — Phase 2
Atopic Dermatitis Research Study Groups: Nemolizumab, Placebo
Atopic Dermatitis Clinical Trial 2023: Nemolizumab Highlights & Side Effects. Trial Name: NCT04365387 — Phase 2
Nemolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04365387 — Phase 2

Frequently Asked Questions

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

Are elderly individuals above the age of 65 able to participate in this clinical experiment?

"This trial is looking to include patients between 12 and 54 years old. There are 101 studies targeting individuals younger than twelve, while 161 look at seniors over 65."

Answered by AI

Could you provide a summary of the previous research conducted with Nemolizumab?

"Currently, there are nine studies running on Nemolizumab with six of them in the Phase 3 trial stage. Though most of these trials stem from Regensburg, Missouri, numerous clinical locations across America have data collection efforts for this drug underway (with a total 959 sites)."

Answered by AI

How many volunteers are partaking in the research?

"Correct. Information posted on clinicaltrials.gov certifies that this medical trial, which was first uploaded on March 5th 2020, is currently searching for participants. A total of 200 people need to be procured from 61 distinct research facilities."

Answered by AI

How many locations are administering this experiment?

"Currently, 61 different medical centres are welcoming prospective participants into this study. These locations span from Miami Lakes and Hialeah to Kew Gardens; you should consider the clinic nearest your residence to reduce travel-related stresses if you choose to participate."

Answered by AI

Who is eligible to join the research cohort of this clinical trial?

"To be admitted as a participant, patients should suffer from eczema of the infantile type and fall between 12 to 54 years old. The clinical trial has room for 200 individuals in total."

Answered by AI

Are researchers currently recruiting participants for this research study?

"Indeed, according to clinicaltrials.gov, recruitment for this medical research is in full swing since its initial launch on March 5th 2020 and most recent update on July 12th 2022. 200 test subjects are being sought from 61 distinct sites."

Answered by AI

Has the FDA granted authorization for Nemolizumab?

"Nemolizumab has been evaluated in a Phase 2 clinical trial, so it is assigned a score of 2 due to the limited evidence backing its safety and lack of efficacy data."

Answered by AI

Is this pioneering medical research the first of its kind?

"As of now, 9 on-going clinical trials for Nemolizumab have been identified worldwide, spanning 25 countries and 228 cities. Galderma R&D initiated the first study in 2019 with 750 participants; since then a total of 18328 studies have concluded their Phase 3 approval stage."

Answered by AI

Who else is applying?

What state do they live in?
California
North Carolina
Virginia
Other
How old are they?
18 - 65
What site did they apply to?
Galderma Investigational Site (Site#8847)
Galderma Investigational Site (Site#9924)
What portion of applicants met pre-screening criteria?
Met criteria
~49 spots leftby Mar 2025