Atopic Dermatitis
Conditions
Interventions
Cohort 1, Group 1, CPI-818:CPI-818, 100mg bid po
Cohort 1, Group 1, placebo:Placebo (100mg), bid po
Cohort 1, Group 2, CPI-818 (Phase 1b):CPI-818, 200mg qd po
Cohort 1, Group 2, placebo (Phase 1b):Placebo (200mg), qd po
Cohort 2, Group 1, CPI-818 (Phase 1b):CPI-818, 200mg bid po
Cohort 2, Group 1, placebo (Phase 1b):Placebo (200mg), bid po
Cohort 2, Group 2, CPI-818 (Phase 1b):CPI-818, 400mg qd po
Cohort 2, Group 2, placebo (Phase 1b):Placebo (400mg), qd po
Cohort 3, Group 1, CPI-818 (Phase 2):CPI-818, 200mg bid po
Cohort 3, Group 2, CPI-818 (Phase 2):CPI-818, 400mg qd po
Cohort 3, Group 3, placebo (Phase 2):Placebo (400mg), bid po
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult male or female, 18 years of age or older at screening. 2. Atopic dermatitis was confirmed by a dermatologist according to Hanifin and Rajka criteria. 3. Confirmed diagnosis of moderate-to-severe atopic dermatitis, defined as meeting at least one of the following criteria: (1) vIGA>=3; (2) EASI>=16; (3) BSA>10%; (4) vIGA×BSA>130. 4. Male subjects must agree to use contraception during treatment and for at least 120 days after the last dose of the trial drug and must not donate sperm during this period. 5 Female subjects were eligible to participate if they were not pregnant and lactating and met at least one of the following criteria: not a fertile woman (WOCBP), or WOCBP who agreed to follow contraceptive instructions during treatment and for at least 120 days after the last study treatment. 6. Able to understand and sign informed consent. 7. Be able to follow all study procedures.
Exclusion criteria
Exclusion criteria: 1. Presence of concurrent or prior skin conditions/injuries (e.g., psoriasis, cutaneous lupus, prior burns, or extensive tattoos) that may interfere with the assessment of the study drug’s effect on atopic dermatitis (AD). 2. Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks after randomization, or that may interfere with accurate evaluation of AD lesions. 3. Oral prednisone or its equivalent, or systemic non-oral corticosteroid administration within 4 weeks prior to randomization. 4. Oral or injectable immunosuppressive agents (e.g., methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, JAK inhibitors, or tacrolimus) administered within 4 weeks prior to randomization (or within 5 half-lives of the drug, whichever is longer). 5. Use of dupilumab (e.g., Dupixent) within 8 weeks prior to randomization, or use of other biologics (e.g., interferons, adalimumab, rituximab, etc.) within 12 weeks prior to randomization (or within 5 half-lives of the drug, whichever is longer). Excluded are biologics with no known immunomodulatory activity, such as insulin, inclisiran (a small nucleic acid drug for hyperlipidemia), or albumin. 6. Use of phototherapy, sunbathing, or prolonged sun exposure. 7. Systemic use of moderate or strong CYP3A inhibitors, moderate or strong CYP3A inducers, or CYP3A sensitive substrates within 4 weeks prior to randomization (or within 5 half-lives of the drug, whichever is longer). 8. Pregnancy or lactation at screening or randomization, or females who plan to become pregnant or lactate during the study or within approximately 120 days after the last dose of study drug. 9. Males who plan to father a child or donate sperm during the study or within approximately 120 days after the last dose of study drug. 10. History of drug-independent immunosuppression (e.g., common variable immunodeficiency, CVID); clinically significant medical history (e.g., anemia, neutropenia, thrombocytopenia, renal or hepatic dysfunction); elective surgery; prolonged wheelchair-bound or bedridden status; or severely impaired functional status preventing self-care. 11. Unstable or poorly controlled diseases including but not limited to: cardiovascular/cerebrovascular diseases (e.g., unstable angina, uncontrolled hypertension, moderate to severe heart failure, NYHA Class III/IV), respiratory, gastrointestinal, endocrine, hematologic, or neurological disorders that may compromise subject safety or confound efficacy and safety assessments. 12. Subjects with moderate or severe renal impairment, defined as estimated glomerular filtration rate (eGFR) =2.0 mg/dL, serum albumin 4 seconds. 14. Positive tuberculosis T-SPOT test, or positive hepatitis B surface antigen (HBsAg) or HBV-DNA, or positive HIV antigen or antibody, or positive hepatitis C virus (HCV) antibody or nucleic acid, or positive syphilis antibody test. 15. Any of the following laboratory abnormalities preclude enrollment: (1)Hematocrit =2 times the upper limit of normal 16. Subjects unable to take oral medication or with malabsorption. 17. Known
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, nature, and severity of adverse events occurring during treatment, including changes in laboratory tests, vital signs, and electrocardiograms.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent of reaching validated Investigator Global Assessment (vIGA) of 0 or 1;Percent change in Eczema Area and Severity Index (EASI) ;Proportions of participants attaining EASI 50/75/90;Change in Peak Pruritus Numerical Rating Scale (PP-NRS);PK characteristics of CPI-818; | — |
Countries
China
Contacts
Public ContactShi Yuling; Zhu Quangang
Shanghai Skin Disease Hospital
Outcome results
None listed