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.
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.
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.
Parallel
Nemolizumab 30 mg
Biological/VaccineAt 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 interventionAt 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.
EASI-75
Proportion of subjects with Eczema Area and Severity Index (EASI)-75 (≥ 75% improvement in EASI from baseline)
IGA success
Proportion of subjects with Investigator Global Assessment (IGA) success (defined as an IGA of 0 \[clear\] or 1 \[almost clear\] and a ≥ 2-point reduction from baseline)
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This trial is not recruiting at the moment. You can still explore other options:
