Atopic dermatitis
Conditions
Interventions
Treatment group:Double-blind treatment period: receive topical ruxolitinib phosphate 1.5% cream twice a day (at least 8 hours apart), apply it thinly on the affected area
Open-label treatment period:
Placebo group:Double-blind treatment period: Receive topical placebo cream twice daily (at least 8 hours apart), applied thinly to the affected area
Open-label treatment period: receive topical ruxoli
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, age = 12 years; 2. At baseline, the symptoms and signs related to AD in adolescents (12 years = age < 18 years) and adults (age =18 years)were at least 2 year; Participants diagnosed with AD as defined by the Hanifin and Rajka (1980) criteria at the time of screening/baseline visit; 3. Participants with an IGA score: a.Double-blind period: 2-3 points at screening and baseline b.Open-label period: 0-4 points at Week 8 4. Participants with %BSA (excluding scalp) of AD involvement: a.Double-blind period: 3-20% at screening and baseline b.Open-label period: 0-20% at Week 8 5. Itch NRS score = 4 prior to first application on Day 1 (D1) [defined as average Itch NRS at least 4 of 7 days prior to first application on D1]. 6. Participants who have at least 1 "target lesion" that measures approximately 10 cm2 or more at screening and baseline. Lesion must be representative of the participant's disease state and not be located on the hands, feet, or genitalia; 7. Participants with the following criteria for tuberculosis (TB) evaluation at screening: a.No history of active TB; b.Chest Computed Tomography without any evidence of current active TB or previous inactive TB; c.Interferon-gamma release assay was negative(such as QuantiFERON-TB and T-SPOT.TB); d.A positive interferon-gamma release test (such as QuantiFERON-TB and T-SPOT.TB) without any evidence of current active TB or prior inactive TB on chest Computed Tomography was required to fulfill medical history and physical examination without symptoms and signs of active TB, as judged by a tuberculosis specialist if necessary; 8. Negative pregnancy test at screening and baseline for women of childbearing potential; 9. Male and female participants of childbearing potential agree to use effective contraceptive methods within 90 days (males) and 30 days (females) after signing the informed consent form to the last dose, respectively, except for females without childbearing potential. Note: Females of non-childbearing potential include prepubescent adolescents, female participants who postmenopause (have no other medical reason for menopause for one year or more) or permanently sterilized (eg, tubal ligation, hysterectomy, or bilateral salpingectomy, etc); 10. Adult participants should fully understand the trial contents, voluntarily participate in the trial, and sign the informed consent form; for participants under 18 years , written informed consent should be obtained from the participants themselves and their parents or legal guardians at the same time. If the participant reached legal age (18 years) during the course of the study, the participant required written informed consent again.
Exclusion criteria
Exclusion criteria: 1. Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline. 2. Patients with the following diseases or past medical history: a.Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome, etc) b.Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before randomization c.Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox)) within 1 week before randomization d.Any other concomitant skin disorder (eg, generalized erythroderma, Netherton syndrome), or pigmentation, scarring, fetal spots, tattoos , etc. may interfere with the evaluation of AD lesions e.Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds f.Other types of eczema within the 6 months prior to screening.(eg, contact dermatitis, neurodermatitis, sweating eczema, nummular eczema/discoid eczema, seborrheic dermatitis, stasis dermatitis, seborrheic dermatitis on the scalp is allowed) 3. Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. For example: a.Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction, or stroke within 6 months prior to baseline, congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia requiring treatment, uncontrolled hypertension (defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, or uncontrolled hypertension in the opinion of the investigator) b.Participants with a history of malignancy in the 5 years preceding enrollment into this study, except for adequately treated, nonmetastatic nonmelanoma skin cancer c.Current and/or history of arterial or venous thrombosis, including deep venous thrombosis and pulmonary embolism. d.Low hemoglobin (< 10 g/dL) e.Estimated glomerular filtration rate < 30 mL/min/1.73 m2 (using the Chronic Kidney Disease Epidemiology Collaboration equation) f.Human immunodeficiency virus (HIV) antibody positive, or hepatitis C virus (HCV) antibody positive and HCV-RNA positive, or hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV) DNA copy number = 1×103 copies/mL; g.Current or past psychiatric disorder or history 4. Participants using any of the following treatments within the indicated washout period before randomization: a.5 half-lives or 12 weeks (whichever is longer), receipt of biologic agents used to treat autoimmune disease (eg, dupilumab) b.4 weeks 1) Systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); 2) Systemic or topical use of JAK inhibitors; 3) Receipt of live or live-attenuated vaccines (use of live or live-attenuated vaccines is prohibited during the stud
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving IGA-TS (IGA-TS is defined as achieving an IGA score of 0 or 1 and an improvement of = 2 points from baseline) at Week 8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieving EASI 75 (EASI 75 defined as = 75% improvement from baseline in Eczema Area and Severity Index score (EASI)) at Week 8;Proportion of participants achieving an improvement of = 4 points in Itch NRS score from baseline at Week 8;Proportion of participants achieving IGA-TS at Weeks 2 and 4;Proportion of participants achieving IGA 0 or 1 at Weeks 2, 4, 8, 12, 16, 20 and 24;Proportion of participants who achieving EASI 75 at Weeks 2 and 4;Proportion of participants with a = 4- point improvement in Itch NRS score from baseline to Weeks 2 and 4;Percent change from baseline in EASI score at Weeks 2, 4, and 8;Proportion of participants who achieving EASI 50, 90 at Weeks 2, 4 and 8;Change from baseline in Itch NRS score at Weeks 2, 4, and 8;Percent change from baseline in affected body surface area (BSA) at Weeks 2, 4, 8, 12, 16, 20 and 24;Percent change from baseline in SCORAD score at Weeks 2, 4 and 8;Change from baseline in Dermatology Life Quality Index (DLQI) score at Weeks 2, 4, 8, 12, 16, 20 and 24(CDLQI applicable for adolescents);Proportion of participants with clinically meaningful improvement (= 6 points) in the Patient Reported Outcomes Measurement Information System (PROMIS ?) Short Form-Sleep-related Impact (8a-24 hour recall) score and Short Form-Sleep Distress (8b-24 hour recall) score at Weeks 2, 4, and 8;Change from Baseline in PROMIS Short Form-Sleep-related Impact (8a-24 hour recall) Score and Short Form-Sleep Distress (8b-24 hour recall) Score at Weeks 2, 4, 8; | — |
Countries
China
Contacts
Public ContactYuling Shi
Shanghai Skin Disease Hospital
Outcome results
None listed