Atopic dermatitis
Conditions
Interventions
ZL-82 Tablets 100mg group:Oral administration: Take 2 tablets each time (1 tablet of each placebo drug), once a day. Take the medicine on an empty stomach at approximately the same time every morning.
ZL-82 Tablets 200mg group:Take orally, 2 tablets each time (2 tablets of the medicine), once a day. Take the medicine on an empty stomach at approximately the same time every morning.
Placebo group:Oral administration: Take 2 tablets each time (2 tablets of placebo), once a day. Take the medicine on an empty stomach at approximately the same time every morning.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female individuals aged 18 years and above and 75 years and below (inclusive of the threshold value, based on the date of signing the ICF), with BMI >= 19 kg/m2. 2. Participants are fully informed of the purpose and requirements of this trial, and voluntarily sign the informed consent form. 3. According to the Hanifin & Rajka diagnostic criteria (= 3 out of 4 main symptoms, >= 3 out of 23 secondary symptoms, see Appendix 1), diagnosed as AD by the investigators, and with a history of AD for >= 1 year before screening. 4. The definition of moderate to severe atopic dermatitis during screening and baseline period is as follows: a. IGA score of 3 or 4; b. EASI score >= 16; c. Average peak pruritus NRS score >= 4 in the past week (Note: The NRS average value is the average of the maximum NRS score of pruritus intensity over 7 consecutive days before baseline, with a score range of 0-10 for each day. At least 4 days of scores are required for the calculation of the average score); d. BSA (body surface area) affected by AD >= 10% (BSA: body surface area, in this trial, BSA is based on the average human body surface area of 1.6 m2); 5. Participants who have been treated with local corticosteroid drugs, calcineurin inhibitors, or phototherapy within the past 6 months, and whose medical history indicates inadequate response, no response, or intolerance to these treatments, or who have medical contraindications for such treatments (treatment duration = 4 weeks), and who require systemic treatment to control the disease, should be selected. Note: For stable treatment response that is insufficient when using local drugs (such as moderate-to-high potency topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)), insufficient response is defined as participants receiving treatment for the recommended duration or the maximum recommended duration as per the instructions, but failing to achieve and maintain disease remission (corresponding to IGA score = 0 [clear] - 2 [mild]). 6. Use a mild moisturizing agent (moisturizing cream) at a stable dose twice a day for at least 7 consecutive days before the first day of administration, and agree to continue using it during the study.
Exclusion criteria
Exclusion criteria: 1. Allergy to the test drug or any component thereof, or allergy or intolerance to other oral Janus kinase (JAK) inhibitors. 2. Use of any of the following drugs or treatments: a. Within 1 month before the baseline, received other oral JAK inhibitor treatment, or had a lack of efficacy or intolerance to other oral JAK inhibitors, including but not limited to baricitinib, upadacitinib, abrocitinib, etc.; b. Within 6 weeks before the baseline, used upadilunab/spicibaydin; c. Within 3 months before the baseline (or within 5 drug half-lives, whichever is longer), used other systemic biological agents known or potentially affecting AD other than dupilumab (such as IL-13 receptor antibody [crizorilumab], IL-31Ra antibody [nimotuzumab] etc.); d. Within 1 week before the baseline, used any AD topical treatment: TCS, TCI, PDE-4 inhibitor, JAK inhibitor, traditional Chinese medicine / Chinese patent medicine, herbal medicine, etc.; e. Within 4 weeks before the baseline (or within 5 half-lives, whichever is longer), used any systemic treatment for AD: immunosuppressants (such as cyclosporine, methotrexate, azathioprine, mycophenolate mofetil, etc.), glucocorticoids, PDE-4 inhibitor, etc.; f. Within 4 weeks before the baseline received any systemic treatment for AD or other autoimmune inflammatory diseases, common AD herbal medicine preparations or Chinese patent medicines; g. Within 4 weeks before the baseline received phototherapy (narrow-band ultraviolet B [NBUVB], ultraviolet B [UVB], ultraviolet A1 [UVA1], psoralen + ultraviolet A [PUVA]), sunbed or any other light-emitting device treatment; h. Within 6 months before the baseline received allergen-specific immunotherapy; i. Within 2 weeks before the baseline or within 5 half-lives of the drug (whichever is longer), systemically used (or expected to be needed throughout the study period) strong or moderate inhibitors or inducers of cytochrome P450 (CYP) (see Appendix II); j. Within 2 weeks before the baseline or within 5 half-lives of the drug (whichever is longer), systemically used (or expected to be needed throughout the study period) P-glycoprotein (P-gp) inhibitors (see Appendix II); k. Had received lymphocyte depletion therapy before (such as: alegrucilunab, anti-CD4 drugs, cladribine, rituximab, omalizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, darzalex); l. Within 3 months before the baseline or within 5 half-lives of the drug (if known, whichever is longer), received any treatment in clinical studies of drugs or medical devices, or was currently enrolled in another interventional study. 3. Individuals with a history of major diseases: This includes but is not limited to those with a history of diseases in the digestive system, cardiovascular system, respiratory system, musculoskeletal system, endocrine system, nervous and mental system, hematological system, immune system disorders, thromboembolic diseases (or individuals at high risk of thromboembolism), and metabolic abnormalities, or those who have undergone major surgeries, or any other diseases or physiological conditions that the investigator deems may affect the trial results. 4. Family Planning: a. Pregnant or lactating women; b. Throughout the entire study period, all participants or their spouses (or partners) who have reproductive capacity must ensure to take effective contraceptive measures from the moment of signing the informed consent form until 90 days after the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In the 16th week, the percentage changes in the Eczema Area And Severity Index (EASI) scores from baseline were compared between the ZL-82 tablets dose group and the placebo group.; | — |
Secondary
| Measure | Time frame |
|---|---|
| At the 2nd, 4th, 8th and 12th weeks, the percentage changes of EASI scores relative to the baseline in the ZL-82 tablets dose groups were compared with those in the placebo groups respectively.;At the 2nd, 4th, 8th, 12th and 16th weeks, the proportions of participants in the ZL-82 tablet dose groups who showed at least a 50% improvement (EASI-50), 75% improvement (EASI-75) and 90% improvement (EASI-90) in the EASI score were compared respectively between the ZL-82 tablets dose groups and the placebo groups.;At weeks 2, 4, 8, 12 and 16, the proportions of participants in the ZL-82 tablets dose groups and the placebo group who had an overall investigator’s global assessment (IGA) score of 0 or 1 and showed a 2-point improvement relative to the baseline were compared.;At the 2nd, 4th, 8th, 12th and 16th weeks, the proportions of participants whose IGA scores improved by = 2 points relative to the baseline were compared between the ZL-82 tablets dose group and the placebo group.;At the 2nd, 4th, 8th, 12th and 16th weeks, the proportions of participants whose IGA scores improved by = 2 points relative to the baseline were compared between the ZL-82 tablets dose group and the placebo group.;At weeks 2, 4, 8, 12 and 16, the proportion of participants whose weekly average PPNRS scores were = 4 points relative to the baseline was compared between the ZL-82 tablets dose group and the placebo group.;At the 2nd, 4th, 8th, 12th and 16th weeks, the changes in the body surface area (BSA) affected by the lesion of the ZL-82 tablets dose group and the placebo group relative to the baseline were compared respectively.;At the 2nd, 4th, 8th, 12th and 16th weeks, the changes in Dermatology Life Quality Index (DLQI) relative to the baseline were compared between the ZL-82 tablets dose group and the placebo group respectively.;At the 2nd, 4th, 8th, 12th and 16th weeks, the changes in the scores of the Patient-Oriented Eczema Measure (POEM) of the participants in the ZL-82 tablets dose gro | — |
Countries
China
Contacts
Public ContactXian Jiang/Ping Feng
West China Hospital of Sichuan University
Outcome results
None listed