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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)
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
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
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 moreSide effects data
From 2018 Phase 2 trial • 226 Patients • NCT0310034433%
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%
Cough
2%
Arthralgia
2%
Pyrexia
2%
Cardio-respiratory arrest
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
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
~2750
Find a Location
Who is running the clinical trial?
Galderma R&DLead Sponsor
300 Previous Clinical Trials
60,232 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had eczema for at least 2 years.You have a skin condition with a score of 16 or higher on the Eczema Area and Severity Index.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.You experience severe itching with a score of at least 4 out of 10.
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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