atopic dermatitis (AD)
Conditions
Interventions
First Treatment Period(From week 0 to week 16) Arm A:QX005N injection.
Different dose regimens for adult and 12-17 years patients:
Adult patients: 450 mg, Q2W.
Patients aged 12-17 years:
450 mg(Q2W)
First Treatment Period(From week 0 to week 16) Arm B:Matching placebo of QX005N injection for specific patients.
Second Treatment Period(From week 16 to week 52):QX005N injection.
Different dose regimens for adult and 12-17 years patients:
Adult patients: 450 mg, Q2W.
Patients aged 12-17 years:
450 mg(Q2W) QX0
Sponsors
Peking Union Medical College Hospital, The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1)12-70 years old (including 12 and 70) by the screening visit, male or female. Note: A specific requirement for<18 years old teenagers is weight should =30 kg. 2)Diagnosed as AD( diagnostic guideline: AAD Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis published in 2014) , and meet all the following criteria below at the same time: a.Has been diagnosed for =1 year before the screening visit. b.IGA score=3, EASI score=16, body surface affected by AD=10%,average weekly daily PP-NRS =4(a minimum of 4 daily scores out of the 7 days is required). c.History of inadequately controlled with topical medicine(eg, TCS) before the screening visit(didn’t reach stable remission or low disease activity(i.e. IGA=1 or 2) after regularly apply for at least 14 days(medium-to-higher potent for at least 28 days) within 1 year before the baseline visit), or topical medicine are not medically advisable(eg, important side effects or safety risks), as judged by investigator. 3)Apply a stable dose of emollient(moisturizer) twice daily for consecutive 7 days immediately before randomization.(For patients who don’t meet the requirement, randomization should be postponed.) 4)Men or women of child-bearing potential promise to use a contraceptive method during the study until 6 months after the last dose of the investigation medicinal product(IMP). Negative hCG results for Women of child-bearing potential at the screening visit and D1 before the first dose of the IMP. Either donate or cryopreserve germ cells is not permitted during the period above. 5)With ability to understand requirements and study procedure. Willing and able to sign a contents of informed consent form (ICF), and comply with all the planned study visits requirements and visit procedures. Note: Patients aged =18 years: voluntarily agree to participate the study, and sign an ICF himself or herself. Patients aged 12-17 years: both himself or herself and his or her parent or a guardian are voluntarily agree to participate the study, and sign ICFs for children and adult respectively.
Exclusion criteria
Exclusion criteria: 1)Pregnant or breast-feeding women, or plan of pregnant during the whole study. 2)Allergic to pharmaceutical ingredients of investigational medicinal product (IMP). 3)History of severe allergic to specific drugs or food. 4)History of alcohol abuse (defined as>2 units per day, or >14 units per week, 1 unit alcohol equals to 360 mL beer or 45 mL 40% wine or 150 mL red wine) or drug abuse within 12 months before randomization. 5)Have used any of the following treatments: a.History of treatment with IL-4Ra or IL-13 targeting antibodies. b.Treatment for AD with topical medicine or for other disease which create potential disturbance for AD assessment within 2 weeks before randomization, such as, but not limited to, the following: TCS, TCI, topical PDE-4 inhibitor, Aryl hydrocarbon receptor agonist, or TCM or herbs(except treatment for other disease which is considered as a necessity and bring little interference to study assessment after judgement by investigator). c.Treatment with prescription moisturizers or moisturizers containing additives(eg, ceramide, hyaluronic acid, filaggrin degradation products) or anti-itch components(eg,menthol, multi-hydroxyl ethanol, pramoxine, lidocaine, procaine, capsaicin, naltrexone, N-dimethylethanolamine laurate)within 2 weeks before randomization.(basic moisturizer(emollient) provided by sponsor is permitted) d.Treatment with bleach bath within 4 weeks before randomization. e.Systematic treatment with corticosteroids or immunosupressive/immunomodulating agents(eg, cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, or oral JAK inhibitor) within 4 weeks before randomization(except treatment with transnasal inhalation or spray corticosteroid). f.Treatment with any cell-depleting agents within 12 months before randomization(including but not limited to anti-CD20, anti-CD52, anti-CD4, anti-CD5, anti-CD3, anti-CD19 biologics). g.Treatment with other immunomodulating biologics within 3 months or <5 PK half-lives(whichever is longer) before randomization. h.Treatment with systemic traditional Chinese medicine(TCM) therapies or herbs within 4 weeks before randomization (except treatment for other diseases which considered not cause interference for PN assessment, in the judgement of a investigator or specialist) i.Treatment with cryotherapy(eg, NB-UVB, BB-UVB, UVA1, PUVA, tanning beds or any LED phototherapy) within 4 weeks before randomization. j.Participation in another investigational medicine studies within 3 months or <5 PK half-lives(whichever is longer) before randomization, or investigational device studies within 3 months. k.Treatment with a live vaccine or an attenuated vaccine within 3 months before randomization, or planned for a live vaccine or an attenuated vaccine during the study period. l.History of treatment with an allergen immunotherapy within 6 months before the baseline visit(except patients treated with a stable therapy dose before the screening visit and continue the stable dose during the study). 6)Presence of other skin comorbidities that may interfere with study assessment at the screening visit and the baseline visit. 7)History of VKC or AKC infection before the screening visit. 8)Diagnosed with unstable medical conditions at the screening visit, such as cardiovascular disease, pulmonary disease, kidney disease, hepatic disease, nervous diseases, endocrine disease, metabolic disease, hematological system diseases at the screening visit, etc. 9)History of malignancy be
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with Eczema Area and Severity Index Score (EASI) achieved 75% improvement (EASI-75) at week 16. ;Percentage of participants with Investigator's Global Assessment(IGA) score of 0 (clear) or 1 (almost clear) and a reduction of at least 2-point at week 16.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Eczema Area and Severity Index Score (EASI) from Baseline to week 16.;Percent change in EASI score at week 16.;Percentage of participants with EASI-50 at week 16.;Percentage of participants with EASI-90 at week 16.;Percentage of participants with a reduction of at least 2-point of IGA score from baseline to week 16.;Percentage of participants with a reduction of =4 points of weekly average of Peak Daily Pruritus Numerical Rating Scale (PP-NRS) score from baseline to week 16. ;Percentage of participants with a reduction of =3 points weekly average of Peak Daily Pruritus Numerical Rating Scale (PP-NRS) score from baseline to week 16. ;Change in weekly average of PP-NRS score from baseline to week 16.;Percent change in weekly average of PP-NRS score from baseline to week 16.;Percent change in weekly average of PP-NRS score from baseline to week 4.;Percent change in Body Surface Area (BSA) affected by AD from baseline to week 16.;Percent change in SCORing Atopic Dermatitis (SCORAD) Score from baseline to week 16.;Change in Dermatology Life Quality Index (DLQI) score from baseline to week 16.;Change in Patient Oriented Eczema Measure(POEM) from baseline to week 16.;Number and duration of flares, and number of affected participants by flares from baseline to week 16.;Percentage of participants with EASI-75 at week 52 of those who achieved EASI-75 at week 16.;Percentage of participants with IGA score of 0 or 1 at week 52 of those who achieved IGA score of 0 or 1 at week 16.;Percentage of participants with EASI-75 at every visit in the second treatment period of those participants whose EASI score improvement achieved more than 50% but less than 75% at week 16.;Percentage of participants with EASI-50 at week 52.;Percentage of participants with EASI-75 at week 52.;Percentage of participants with EASI-90 at week 52.;Score change and percentage change in EASI score from baseline to week 52.;Percentage of participants with IGA score of 0 or 1 and a reduction of at le | — |
Countries
China
Contacts
Public ContactJin Hong Zhong, Gao Xing Hua
Peking Union Medical College Hospital, The First Hospital of China Medical University
Outcome results
None listed