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

Sponsor
Galderma R&D
Study ID
NCT07762833
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nemolizumab 30 mg — BIOLOGICAL
    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.
  • Placebo — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 13, 2026
Start date
Sep 28, 2026
Status verified
Jul 2026
Primary completion
Sep 28, 2027
Completion
Sep 28, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nemolizumab treatment group
    160 subjects will be randomized to Nemolizumab treatment group
  • Placebo Comparator: Placebo control group
    80 subjects will be randomized to placebo control group.

Primary Outcome Measure

EASI-75 [ Time Frame: Week 16 ]

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