MedTrace Logo

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to or for Whom Cyclosporine A is Not Medically Advisable

NCT05056779 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2023-09-21

No results posted yet for this study

Summary

The primary objective of this study is to investigate the efficacy of nemolizumab administered in combination with topical background therapy (topical corticosteroids \[TCS\] with or without topical calcineurin inhibitors \[TCI\]) in adult participants with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with or are not advised to use oral cyclosporine A (CsA) for medical reasons. The secondary objective is to investigate the safety of nemolizumab in adult participants with moderate-to-severe AD who are not adequately controlled with or are not advised to use oral CsA for medical reasons.

The study will be carried out in up to 70 different locations across Europe.

Conditions

Interventions

DRUG

Nemolizumab

Participants will receive loading dose of 60 milligram (2×30 mg) subcutaneous (SC) injection of nemolizumab at baseline. Thereafter 30 mg nemolizumab will be administered via single SC injection once in 4 week (Q4W) up to week 12.

DRUG

CD14152 placebo

Participants will receive loading dose of 60 mg (2×30 mg) SC injection of placebo at baseline. Thereafter 30 mg placebo will be administered via single SC injection Q4W up to week 12.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2023-07-31
Completion
2023-07-31
FDA Drug
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056779 on ClinicalTrials.gov