An Open-label Drug-Drug Interaction Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Subjects with Moderate-to-Severe Atopic Dermatitis

Galderma S.A.0 sites25 target enrollmentNovember 11, 2020

ConditionsModerate-to-severe atopic dermatitis MedDRA version: 21.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858 Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

DrugsMidazolam Injection, USP MsKesson Omeprazole Delayed Release Tablets 20 mg WARFARIN SODIUM – warfarin sodium tablet JET-ALERT Regular Strength Metoprolol Tartrate Tablets, USP

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Moderate-to-severe atopic dermatitis
Sponsor: Galderma S.A.
Enrollment: 25
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 11, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Galderma S.A.

Eligibility Criteria

Inclusion Criteria

•1\. Subjects aged \= 18 years at the time of screening.
•2\. Chronic AD for at least 2 years before the screening visit, and confirmed according to American Academy of Dermatology Consensus Criteria at the time of the screening visit.
•3\. EASI score \= 16 at both the screening and baseline visits.
•4\. IGA score \= 3 at both the screening and baseline visits.
•5\. AD involvement \= 10% of body surface area (BSA) at both the screening and baseline visits.
•6\. Peak (maximum) pruritus numeric rating scale (PP NRS) score of at least 4\.0 at both the screening and baseline visit.
•7\. Documented recent history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI). All subjects must demonstrate inadequate response to TCS. All
•subjects who have used TCI within 6 months of the screening visit must
•also demonstrate inadequate response to TCI. Acceptable documentation
•includes subject records with information on TCS (with or without TCI)

Exclusion Criteria

•1\. Body weight \< 45 kg
•2\. Subjects meeting 1 or more of the following criteria at screening or baseline:
•a. Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
•b. Reporting asthma that has not been well\-controlled (i.e., symptoms occurring on \> 2 days per week, night\-time awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months.
•c. Asthma Control Test (ACT) \= 19 (only for subjects with a history of asthma)
•d. Peak expiratory flow \< 80% of the predicted value.
•3\. Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
•4\. Cutaneous infection within 1 week prior to the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks prior to the baseline visit, or any confirmed or suspected coronavirus disease (COVID)\-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID\-19 infection can be confirmed by recovery assessment methods.
•5\. Requiring rescue therapy for AD during the screening period or expected to require systemic rescue therapy during the treatment period.
•6\.Positive serology results (hepatitis B surface antigen \[HBsAg] or hepatitis B core antibody \[HBcAb], hepatitis C \[HCV] antibody with positive HCV RNA, or human immunodeficiency virus \[HIV] antibody) at the screening visit.