patients =12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD).
Conditions
Interventions
Group A (body weight: patient = 60kg):QX005N: 450mg, Q2W
Group B (body weight: 30 to less than 60 kg ):QX005N: 300mg,Q2W
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: A patient must meet the following criteria to be eligible for inclusion in the study: 1) Male or female =12 to = 3;Eczema Area and Severity Index (EASI) score >= 16;Involved body surface area (BSA) >= 10%; c) (3) According to the assessment of investigator, Patients inadequate response to topical drugs such as medium to super-potent corticosteroids (TCS)(inadequate response is defined as failure to achieve and maintain remission or a low disease activity state [comparable to IGA 0=clear to 2=mild] despite treatment with a daily regimen of TCS of medium to higher potency applied for at least 28 days or 14 days for super-potent TCS in the past 1year before the baseline visit) or not suitable for topical medication (if there are serious side effects or safety risks) . 3) Has applied a stable dose of topical emollient (moisturizer) twice daily for at least the 7 consecutive days immediately before the baseline visit (If the above requirements are not met within 7 days prior to treatment, treatment should be postponed until the requirements are met, but not beyond the maximum screening period of 28 days) 4)Female of Childbearing Potential(FCBP) and male patients who did not undergo vasectomy agreed to adopt a reliable method of contraception (abstinence, prior ligation, oral contraceptives, and/or barrier methods (condoms, diaphragms, cervical caps, etc.) during the study, including 6 months after the end of the study or end of the treatment; and hCG pregnancy tests for FCBP must be negative at screening visits and prior to initial administration; Male patients cannot donate sperm during the study and six months after end of study or treatment. Note: FCBP patients were defined as female subjects who had not achieved postmenopausal status after menstruating (continuous amenorrhea for at least 12 months with no other clear cause other than menopause) and who had no surgical (i.e., bilateral ovariectomy and/or bilateral salpingotomy and/or hysterectomy) or other investigator identified causes of permanent infertility (e.g., malleable canal agenesis). 5)The patient and his/her guardian have the ability to understand the study requirements and procedures, voluntarily participate in the clinical trial, the ICF signed by his/her guardian (signed by at least one guardian), and the Informed consent for minors signed by the patient himself/herself, and are willing and able to comply with the study visit and related procedures.
Exclusion criteria
Exclusion criteria: A patient who meets any of the following criteria will be excluded from the study: 1)History of allergy to ingredients or excipients of IMP, or biologics. 2)Has history of severe allergic reactions to drugs or food or during screening, and the investigator judged that it was not suitable to enter the study. 3)Alcohol (defined as >2 units per day / >14 units per week, 1 unit of alcohol equivalent to 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or drug abusers in the 12 months prior to treatment; 4)Having used any of the following treatments: a)Previous treatment with antibodies against interleukin-4 receptor alpha (IL-4Ra) or interleukin-13 (IL-13); b)Topical drugs for AD or have the potential to affect the evaluation of AD status, including but not limited to TCS, TCI, topical phosphodiesterase-4 (PDE-4) inhibitors, topical Janus kinase (JAK) inhibitors, aromatic hydrocarbon receptor agonists, or topical traditional Chinese medicine (TCM) and herbal treatments, within 2 weeks prior to administration.(Note: For the treatment of diseases other than AD, except where, under judgment of the investigator and/or a specialist, it is deemed necessary and does not influence the evaluation of the study); c)have prescription emollients or , Emollients contain additives (e.g. Ceramide, hyaluronic acid, urea) or anti-itching ingredients (e.g., menthol, polyhydroxyethanol, pramoxine, lidocaine, prilocaine, capsaicin, naltrexone, n-palmitoylethanolamine, etc.) (other than base emollients provided by the study)within 2 weeks prior to administration; d)Have compound glycyrrhizin tablets within 2 weeks prior to administration; e)Bleaching bath within 4 weeks prior to administration; f)systemic treatment with corticosteroids or other immunosuppressive/immunomodulatory drugs (such as cyclosporin, mycophenolate, azathioprine, methoterate, oral JAK inhibitors or oral PDE-4 inhibitors) for AD or other medical conditions (other than corticosteroid inhalers and nasal sprays) within 4 weeks prior to administration; g)received any cell depletion therapy (including but not limited to anti-CD20, anti-CD52, anti-CD4, anti-CD5, anti-CD3, anti-CD19) in the 12 months prior to administration; h)have other immunomodulatory biologics within 3 months prior to administration or within 5 drug half-lives( if known), whichever is longer; i)Oral or other systematic TCM or herbal therapy within 4 weeks prior to administration (note: for disease other than AD, except where the medical judgment of the investigator and/or a specialist deems it necessary and does not interfere with study evaluation); j)Phototherapy (narrow-spectrum ultraviolet B[NB-UVB], broad-spectrum ultraviolet B[BB-UVB], ultraviolet A1[UVA1], psoralen + ultraviolet A[PUVA]), tanning bed or any other light-emitting device (LED) treatment within 4 weeks prior to administration; k)Patients in clinical trials of other drugs within 3 months or at least 5 half-lives (whichever is longer) prior to administration, or participating in clinical trials of medical devices within 3 months prior to administration; l)have received any live or attenuated vaccine within 3 months prior to administration, or plan to receive live or attenuated vaccine during the study ; m)Treatment with allergen-specific immunotherapy (SIT) within 6 months prior to administration (except for patients who were already at a stable dose prior to screening and maintain it during the study). 5) Presence of skin disorders or symptoms tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events (AES) and serious adverse events (SAEs);Percentage of treatment discontinuation due to adverse eventsoccurring during treatment (TEAE) ;The percentage of AE with skin infection;Abnormal changes in laboratory tests, electrocardiogram (ECG), vital signs, physical examination, and injection site;PK parameters [maximum blood concentration (Cmax), area under drug time curve (AUC), half-life (t1/2), etc.]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with eczema Area and Severity Index (EASI) -75 at week 24;Proportion of patients with an Investigator's Overall Assessment (IGA) score of 0 or 1 and =2 points lower than baseline at week 24;EASI score change from baseline at week 24;Percentage change in EASI score from baseline at week 24;The proportion of patients reached EASI-50 at week 24;The proportion of patients reached EASI-90 at week 24;Proportion of patients with IGA scores =2 points lower than baseline at week 24;Proportion of patients whose weekly mean PP-NRS decreased by =4 points from baseline at week 24;Proportion of patients whose weekly mean PP-NRS decreased by =3 points from baseline at week 24;Changes in weekly PP-NRS averages from baseline at week 24;Percentage change in the weekly average PP-NRS from baseline at week 24;Percentage of body surface area (BSA) involved in AD compared to baseline change at week 24;Percentage change score in atopic dermatitis (SCORAD) from baseline at week 24;Changes from baseline in the Dermatology Life Quality Index Questionnaire/Children's Dermatology Life Quality Index (DLQI/CDLQI) at week 24;the situation of generating ADA;Changes in weekly PP-NRS averages from baseline at wee 4; | — |
Countries
China
Contacts
Public ContactLinming Wu
Hangzhou First People's Hospital
Outcome results
None listed