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Randomized, Double-blind, Placebo-controlled Study of Nemolizumab in Chinese Subjects With Moderate-to-severe Atopic Dermatitis

NCT07762833 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-08-13

No results posted yet for this study

Summary

This is a bridging study only for Chinese subjects. The goal of this clinical trial is to learn if drug Nemolizumab works to treat moderate to severe AD in over 12 years old male and female. It will also learn about the safety of drug Nemolizumab.

Researchers will compare drug Nemolizumab to a placebo (a look-alike substance that contains no drug) to see if drug Nemolizumab works to treat moderate to severe atopic dermatitis.

Participants will:

Take drug Nemolizumab or a placebo at baseline and every 4 weeks followed, Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms and the disease situation.

Conditions

Interventions

BIOLOGICAL

Nemolizumab 30 mg

At the baseline visit, nemo arm subject will receive either 30-mg nemolizumab (CD14152) with a 60-mg loading dose via 2 SC injections, then be administered via a single SC injection every 4 weeks (Q4W) at Week 4, 8, and 12 during the Main Treatment Period. At Week 16, subjects will be offered an opportunity to enter the Extension Treatment Period. At week 16, subjects from nemolizumab arm who entering extension treatment period to receive one injection of 30-mg nemolizumab and one placebo injection; from Week 20 to Week 48, to receive nemolizumab 30-mg Q4W.

OTHER

Placebo

At the baseline visit, placebo control arm subjects to receive placebo via 2 SC injections, then be administered placebo via a single SC injection every 4 weeks (Q4W) at Week 4, 8, and 12 during the Main Treatment Period. At Week 16, subjects will be offered an opportunity to enter the Extension Treatment Period. At Week 16 subjects from placebo arm entering Extension Treatment Period receive a LD of 60-mg nemolizumab (two 30-mg injections), from Week 20 to Week 48, all subjects receive nemolizumab 30-mg Q4W.

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-28
Primary Completion
2027-09-28
Completion
2028-09-28

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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 NCT07762833 on ClinicalTrials.gov