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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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 (4 weeks post-vaccination)
Summary
This trial is testing nemolizumab, a medication for severe skin conditions, in people aged 12 to 54 who haven't responded to usual treatments. It aims to see if the drug can help their immune system respond better to vaccines.
Eligible Conditions
- Atopic Dermatitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 16 (4 weeks post-vaccination)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 (4 weeks post-vaccination)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants with a Positive Serum Immunoglobulin G (IgG) Response to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)
Secondary study objectives
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 moreSide effects data
From 2022 Phase 3 trial • 274 Patients • NCT045016797%
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
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
2022
Completed Phase 3
~2750
Find a Location
Who is running the clinical trial?
Galderma R&DLead Sponsor
302 Previous Clinical Trials
60,442 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe allergic reactions (including anaphylaxis) to any immunoglobulin product or any ingredients in the study drug.You have a history of serious allergic reaction to the vaccine or any of its ingredients like alum, thimerosal, or phenol.
Research Study Groups:
This trial has the following groups:- Group 1: Nemolizumab
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
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