Dose-ranging study of nemolizumab in atopic dermatitis

Phase 1

Conditions: Atopic dermatitis
MedDRA version: 20.0Level: PTClassification code 10014184Term: EczemaSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2016-005025-37-PL

Lead Sponsor: GALDERMA R&D, SNC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 351

Inclusion Criteria

- Male or female subjects = 18 years (or legal age when higher)

- Chronic AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]), that has been present for at least 2 years before the visit

- Eczema Area and Severity Index (EASI) score = 12

- IGA score = 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe)

- AD involvement = 10% of BSA

- Severe pruritus, defined as average of pruritus Numeric Rating Score (NRS) for the maximum intensity = 7 during the 7 days prior to the visit.
NOTE: A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.

- Documented recent history (within 6 months before the visit) of inadequate response to topical medications
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 166
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion Criteria

- Body weight < 45 kg

- Subjects with a medical history of asthma that fulfil any one or more of the scenarios below:
* Had an asthma exacerbation requiring hospitalization in the last 12 months before screening visit
* Whose asthma has not been well-controlled (i.e. symptoms >2 days per week, nighttime awakenings >1-3 times per week, or some interference with normal activities) during the last 3 months before the screening visit
* 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.

- Pregnant women (with a positive serum pregnancy test result at the screening visit), breastfeeding women, or women planning to become
pregnant during the clinical trial

- History of intolerance to low or mid potency TCS or for whom TCS is not advisable (e.g. hypersensitivity to TCS or to any other ingredient
contained in the TCSs to be used in the study, significant skin atrophy)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe AD subjects with severe pruritus receiving , Topical Cortico Steroid who were not adequately controlled with topical treatments.;Secondary Objective: The secondary objectives are to evaluate the safety of nemolizumab and to characterize its pharmacokinetic (PK) profile.;Primary end point(s): Percentage change in EASI ;Timepoint(s) of evaluation of this end point: from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Proportion of subjects achieving IGA success<br>2. Percent change in EASI<br>3. Absolute and percent change of the peak and average pruritus <br>4. Proportion of subjects with an improvement of weekly pruritus peak <br>5. Absolute and percent change in weekly sleep disturbance <br>6. Proportion of subjects achieving pruritus categorical scale success<br>7. Proportion of subjects achieving 50%, 75% or 90% reduction from baseline in EASI score<br>8. Absolute and percent change in scoring atopic dermatitis;Timepoint(s) of evaluation of this end point: 1. at each visit up to week 24<br>2. from baseline at each visit up to week 24<br>3. from baseline in weekly at each visit up to week 24<br>4. from baseline to week 24<br>5. from baseline to week 24<br>6. at week 24<br>7. from baseline to week 24<br>8. from baseline to week 24

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