Atopic Dermatitis
Conditions
Interventions
SM17 Group1:Participants will receive Dose 2 of SM17 with fixed interval 1 from week 0~15, with a loading dose at Week 0
SM17 Group2:Participants will receive Dose 2 of SM17 with fixed interval 1 from week 0~15
SM17 Group3:Participants will receive Dose 3 of SM17 with fixed interval 1 from week 0~15,with a loading dose at week0
SM17 Group4:Participants will receive Dose 3 of SM17 with fixed interval 2 from week 0~15, with a loading dose at Week 0
Placebo Group 1:Participants will receive Placebo with fixed interval 1 from week 0~15,with a loadingdose at Week 0
Placebo Group 2:Participants will receive Placebo with fixed interval 2 from week 0~15,with a loadingdose at Week 0
Open labelled Period:Participants will receive Dose 3 of SM17 with fixed interval 1 from week 16~24
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria to be eligible for study participation: 1.Those willing to sign the Informed Consent Form, comply with the study procedures, and receive follow-up at the time points required in the protocol. 2.Participants who are able to understand and complete the study-related questionnaires by themselves or with the assistance of their relatives. 3.Male or female, aged 18-70 years (inclusive) at the time of signing the Informed Consent Form. 4.Those with a previous history of eczema for more than 1 year (based on the earliest medical record).Those who meet the diagnostic criteria for AD (Hanifin & Rajka diagnostic criteria, as detailed in Appendix 9) at screening. 5.Those with a Eczema Area and Severity Index (EASI) score of >= 16 at screening and baseline. 6.Those with an Investigator’s Global Assessment (IGA) score of >= 3 (on the basis of 4-point Validated Investigator Global Assessment for Atopic Dermatitis(vIGA-AD scale)) at screening and baseline. 7.Those with a body surface area (BSA) of AD involvement being >=10% at screening and baseline. 8.Those with a mean maximum pruritus intensity score of Pruritus Numerical Rating Scale (PP-NRS) being >= 4 at baseline. 9.Patients with a recent (within 6 months prior to the screening visit) medical history indicating that they have inadequate response to topical medications or that the use of topical medications is medically inappropriate (e.g., with important side effects or safety risks). 10.Those who use topical mild emollients (moisturizers) at least twice daily for at least 7 consecutive days prior to randomization. For restrictions on the types of emollients not allowed during the study, see Exclusion Criterion 5. 11.Eligible participants of childbearing potential and their partners must agree to use a medically accepted contraceptive measure (e.g., intra-uterine contraceptive device, anticonceptive or condom, or abstinence) during the study and within 6 months after the end of the study, with specific contraceptive measures detailed in Appendix 1; and have no plans to donate sperm/ova during the study and within 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: Participants who meet any of the following criteria will not be enrolled in the study: 1.Those with general conditions:1) Those who are pregnant women (pregnancy is defined as the state from conception until the termination of pregnancy) or lactating women or have a positive serum human chorionic gonadotropin (HCG) test result; 2)Those with alcohol abuse (i.e., an average weekly consumption of more than 14 units of alcohol [1 unit approx 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine]) and/or drug abuse within half a year prior to screening; 2.Those who experience any of the following in laboratory tests and/or ECG at screening or baseline (if necessary, a repeated test can be conducted for confirmation):1) Haemoglobin 2 × ULN(Upper Limit of Normal); 6) Bilirubin total (T-BIL) > 1.5 × ULN(Upper Limit of Normal); 7) Serum creatinine > 1.5 × ULN(Upper Limit of Normal); 8) The hepatitis B surface antigen (HBsAg) test result is positive with HBV-DNA > 1,000 copies/mL, the human immunodeficiency virus antibody (HIV) and anti-hepatitis C virus (HCV) antibody test results are positive or the syphilis infection is present (when the syphilis specific antibody test result is positive, the non-specific antibody test for syphilis shall be added for validation); 9) ECG at screening indicates clinically significant abnormalities that may affect the safety of participants, including but not limited to acute myocardial ischemia, myocardial infarction, serious arrhythmia or significant QTcF prolongation (QT interval corrected by Fridericia’s formula, QTcF >= 450 ms for males and >=470 ms for females); 3. Those with any of the following medical history or comorbidities: 1) History of vernal keratoconjunctivitis (VKC) and/or atopic keratoconjunctivitis (AKC); or active dermatosis that may confound the diagnosis of AD or interfere with the evaluation of treatment (e.g., psoriasis, body tinea, cutaneous lupus erythematosus, etc.), generalized pigmentation or extensive scarring, or other types of eczema (allergic contact dermatitis); 2) Known or suspected history of immunosuppressive diseases, including history of invasive opportunistic infections (e.g., tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, or aspergillosis), although having been relieved; or abnormally frequent, recurrent or long-term infections as judged by the investigator; 3) Participants with chronic active or acute infections requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to screening or from screening to baseline; 4. Those who use any of the following medications/treatments and are not expected to withdraw/discontinue such treatment(s) throughout the study: 1) Those who have received systemic application of corticosteroids, immunosuppressants, Janus kinase inhibitors for AD within 4 weeks prior to baseline; 2) Those who have received antihistamines or inhaled corticosteroids within 1 week prior to baseline (those who have been treated with antihistamines or inhaled corticosteroids at a stable dose for at least 7 days prior to baseline and are scheduled to continue to use them during the study may be enrolled); 3) Those who ha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Eczema Area and Severity Index (EASI)-50 (= 50% improvement from baseline in EASI) ;Eczema Area and Severity Index (EASI)-75 (= 75% improvement from baseline in EASI);Eczema Area and Severity Index (EASI)-90 (= 90% improvement from baseline in EASI);Eczema Area and Severity Index (EASI)-100 ( 100% improvement from baseline in EASI);Investigator Global Assessment for Atopic Dermatitis(IGA); Peak Pruritus Numerical Rating Scale (PP-NRS)NRS-4;Changes and percentage changes from baseline in Eczema Area and Severity Index(EASI);Validated Investigator Global Assessment for Atopic Dermatitis(vIGA-AD);Peak Pruritus Numerical Rating Scale;Peak Pruritus Numerical Rating Scale;Body Surface Area (of atopic dermatitis lesions);SCORing Atopic Dermatitis;Patient-Oriented Eczema Measure(POEM);Dermatology Life Quality Index(DLQI); | — |
Countries
China
Contacts
Public ContactJianzhong Zhang Cheng Zhou
Peking University People's Hospital
Outcome results
None listed