Randomized, Double-blind, Placebo-controlled Study of Nemolizumab in Chinese Subjects With Modera… (NCT07762833) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Randomized, Double-blind, Placebo-controlled Study of Nemolizumab in Chinese Subjects With Moderate-to-severe Atopic Dermatitis
240 participantsStarted 2026-09-28
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Chinese subjects aged ≥ 12 years at the screening visit.
. Chronic AD for at least 2 years before the screening visit and confirmed according to American Academy of Dermatology Consensus Criteria (Eichenfield 2014, Appendix 1) at the time of the screening visit.
. EASI score ≥ 16 at both the screening and baseline visits.
. IGA score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.
. AD involvement ≥ 10% of body surface area (BSA) at both the screening and baseline visits.
. Peak (maximum) pruritus NRS score of at least 4.0 at the screening and baseline visit:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Documented history (within 6 months before the screening visit) of inadequate response to topical medications (TCS with or without TCI). Acceptable documentation includes patient records with information on TCS (with or without TCI) prescription and treatment outcome, or written documentation of the conversation with the subject's treating physician, if different than the investigator.
. Failure to achieve or maintain remission or low disease activity (equivalent to IGA ≤ 2) despite treatment with a regimen of a medium- or high-potency TCS\* (with or without TCI), applied for at least 4 weeks or for the maximum duration per prescribing information; or
Exclusion criteria
. Body weight \< 30 kg.
. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
. Known or suspected history of immunosuppression, or unusually frequent, recurrent, severe, or prolonged infections, as per investigator's judgment.
. History of lymphoproliferative disease or history of malignancy of any organ system within the last 5 years, except for (1) basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the baseline visit, or (2) actinic keratoses that have been treated.
. Presence of confounding skin condition that may interfere with study assessments (e.g. Netherton syndrome, psoriasis, cutaneous T-cell lymphoma \[mycosis fungoides or Sezary syndrome\], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).
. Pregnant women (positive serum pregnancy test result at the screening visit or positive urine pregnancy test at the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study.
. Any medical (e.g., serious cardiac/hepatic/lung \[including uncontrolled asthma\]/hematologic disease) or psychological condition or any clinically relevant laboratory abnormalities, such as but not limited to elevated ALT or AST (\> 3 × upper limit of normal \[ULN\]) in combination with elevated bilirubin (\> 2 × ULN), during the screening period that may put the subject at significant risk according to the investigator's judgment, if he/she participates in the clinical study, or may interfere with study assessments (e.g. poor venous access or needle-phobia).
. Planned or expected major surgical procedure during the clinical study.