Nemolizumab for Eczema

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
EczemaNemolizumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the long-term safety and effectiveness of the drug nemolizumab in people with moderate to severe atopic dermatitis.

Eligible Conditions
  • Eczema

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

5 Primary · 31 Secondary · Reporting Duration: Baseline to Week 200

Baseline to Week 104
Proportion of subjects receiving any concomitant AD treatment
Proportion of subjects receiving any rescue therapy
Baseline to Week 112
Change and percent change from baseline in SCORAD score at each visit
Pruritus
Change and percent change from baseline in subject-reported sleep loss using 10-cm VAS (SCORAD sub-component)
Change and percent change from baseline in the overall Eczema Area and Severity Index (EASI) score at each visit
Change and percent change from baseline in the overall Investigator's Global Assessment (IGA) score at each visit
Incidence and severity of TEAEs
Incidence of serious TEAEs
Proportion of subjects reporting low disease activity state based on PGAD at each visit
Proportion of subjects satisfied with study treatment based on PGAT at each visit
Proportion of subjects with EASI-75 at each visit
Proportion of subjects with IGA score = 0-1 at each visit
Proportion of subjects with IGA ≤ 2 at each visit
Baseline to Week 200
Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) Total Score at Each Visit Through Week 200
Change From Baseline in EuroQoL 5-Dimension (EQ-5D) at Each Visit Through Week 200
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) for Each Subscale at Each Visit Through Week 200
Change From Baseline in Patient-Oriented Eczema Measure (POEM) Total Score at Each Visit Through Week 200
Change From Baseline in Work Productivity and Activity Impairment: Atopic Dermatitis (WPAI:AD) for Each Subscale at Each Visit Through Week 200
Change and Percent Change From Baseline in Overall Eczema Area and Severity Index (EASI) Score at Each Visit
Change and Percent Change From Baseline in Participant-Reported Pruritus Using 10-cm VAS (SCORAD Sub-Component)
Change and Percent Change From Baseline in Participant-Reported Sleep Loss Using 10-cm VAS (SCORAD Sub-Component)
Change and Percent Change From Baseline in SCORAD Score at Each Visit
Change from Baseline in Dermatology Life Quality Index (DLQI)
Duration of Remission
Incidence and Severity of Adverse Events of Special Interest (AESIs) Throughout the Study
Incidence and Severity of TEAEs
Incidence of Serious TEAEs
Proportion of Participants Receiving Any Rescue Therapy by Rescue Treatment Type at Any Visit During the Treatment Period
Proportion of Participants Reporting Low Disease Activity State Based on PGAD at Each Visit
Proportion of Participants Satisfied with Study Treatment Based on PGAT at each visit
Proportion of Participants with EASI-75 at Each Visit
Proportion of Participants with IGA score = 0-1 at Each Visit
Proportion of Participants with IGA ≤ 2 at Each Visit
Time to First Relapse
Time to Permanent Study Drug Discontinuation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Nemolizumab (30 mg)
25%Nasopharyngitis
23%Dermatitis atopic
12%Asthma
11%Upper respiratory tract infection
7%Headache
5%Sinusitis
5%Gastroenteritis
5%Folliculitis
5%Dry skin
5%Rhinitis
5%Arthralgia
5%Cough
5%Back pain
5%Abdominal pain
5%Diarrhoea
2%Blood creatine phosphokinase increased
2%Oral herpes
2%Urinary tract infection
2%Pyrexia
2%Cellulitis
2%Nausea
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT03100344) in the Nemolizumab (30 mg) ARM group. Side effects include: Nasopharyngitis with 25%, Dermatitis atopic with 23%, Asthma with 12%, Upper respiratory tract infection with 11%, Headache with 7%.

Trial Design

1 Treatment Group

Nemolizumab
1 of 1

Experimental Treatment

1700 Total Participants · 1 Treatment Group

Primary Treatment: Nemolizumab · No Placebo Group · Phase 3

Nemolizumab
Drug
Experimental Group · 1 Intervention: Nemolizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 200

Who is running the clinical trial?

Galderma R&DLead Sponsor
289 Previous Clinical Trials
57,944 Total Patients Enrolled
12 Trials studying Eczema
2,478 Patients Enrolled for Eczema

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior ADNI study for AD.

Who else is applying?

What state do they live in?
Texas25.0%
Illinois12.5%
Ohio12.5%
Other50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Galderma Investigational Site 886625.0%
Galderma Investigational Site 822425.0%
Galderma Investigational Site 873325.0%
Other25.0%
What portion of applicants met pre-screening criteria?
Met criteria85.7%
Did not meet criteria14.3%
Why did patients apply to this trial?
  • "Because my skin condition has gotten considerably worse to the pointv"
How many prior treatments have patients received?
0100.0%