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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 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

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 more

Side effects data

From 2022 Phase 3 trial • 274 Patients • NCT04501679
7%
Headache
5%
Dermatitis atopic
4%
Neurodermatitis
1%
Dermatitis contact
1%
Pemphigoid
1%
Pneumonia
1%
Pneumococcal sepsis
1%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab
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
2022
Completed Phase 3
~2750

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
300 Previous Clinical Trials
60,218 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
~44 spots leftby Oct 2025
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