Phase 2
N=226
Dose-ranging Study of Nemolizumab in Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT03100344 ↗Enrolled (actual)
226
Serious AEs
3.6%
Results posted
Oct 2019
Primary outcome: Primary: Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 — -58.4; -72.2; -73.4; -69.2 percentage change — p=0.051
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nemolizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24 |
-58.4; -72.2; -73.4; -69.2 | 0.051 |
| SECONDARY Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24 |
13; 23; 31; 20 | 0.034 sig |
| SECONDARY Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24 |
3; 9; 10; 6; 6; 19 | 0.062 |
| SECONDARY Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 |
-42.6; -60.8; -62.5; -55.9 | 0.017 sig |
| SECONDARY Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24 |
-27.9; -40.1; -40.6; -36.1 | 0.016 sig |
| SECONDARY Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 |
-50.7; -75.4; -76.2; -74.9 | <0.001 sig |
| SECONDARY Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24 |
-3.9; -6.2; -5.7; -5.8 | <0.001 sig |
| SECONDARY Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24 |
1; 1; 2; 0; 2; 1 | 0.970 |
| SECONDARY Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 |
4; 6; 12; 11; 8; 18 | 0.487 |
| SECONDARY Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 |
2; 2; 3; 3; 4; 5 | 0.979 |
| SECONDARY Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24 |
1; 1; 2; 1; 2; 0 | 0.970 |
| SECONDARY Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24 |
1; 1; 2; 0; 2; 1 | 0.970 |
| SECONDARY Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24 |
-12.4; -22.7; -29.3; -28.6; -24.8; -34.9 | 0.049 sig |
| SECONDARY Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 |
-9.8; -22.6; -25.5; -19.8; -12.9; -36.9 | 0.012 sig |
| SECONDARY Number of Participants With Adverse Events |
1; 3; 2; 2; 0; 1 | — |
| SECONDARY Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 |
-0.9; -2.0; -2.3; -1.7; -1.2; -3.1 | <0.001 sig |
| SECONDARY Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 |
-0.9; -2.0; -2.3; -1.8; -1.2; -3.1 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24 |
-11.0; -24.6; -29.4; -23.2; -14.6; -39.9 | <0.001 sig |
Summary
Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects ≥ 18 years (or legal age when higher)
- Chronic AD, that has been present for at least 2 years before the visit
- Eczema Area and Severity Index (EASI) score ≥12
- Investigator Global Assessment (IGA) score ≥ 3
- AD involvement ≥ 10% of Body Surface Area (BSA)
- Severe pruritus on at least 3 of the last 7 days before the visit
- Documented recent history (within 6 months before the visit) of inadequate response to topical medications
- Female subjects must fulfill one of the criteria below:
- Female subjects of non-childbearing potential
- Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration
Exclusion Criteria
- Body weight < 45 kg
- subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of the predicted value
- Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period
- Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
- History of intolerance to low or mid potency TCS or for whom TCS is not advisable
Data sourced from ClinicalTrials.gov (NCT03100344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.