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-FR
• Lead Sponsor: GALDERMA R&D, SNC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-31
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

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

3. Eczema Area and Severity Index (EASI) score = 12

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

5. AD involvement = 10% of BSA

6. Severe pruritus (according to the definition of the pruritus categorical scale [PCS]) on at least 3 of the last 7 days before the visit

7. 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