Lupus Erythematosus Panniculitis
Conditions
Interventions
Treatment:baricitinib
Control:Placebo
Sponsors
Hospital for Skin Diseases(Institute of Dermatology)Chinese Academy of Medical Sciences, Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years to =4 at screening and baseline. 4. Requirements for pregnant or lactating women and male/female patients of childbearing age: Female patients must meet: (1) Menopause (defined as no menstruation for at least 1 year); (2) Or has undergone surgical sterilization; (3) Or have fertility, but must meet: 1) Pregnancy tests performed within 7 days before randomization must be negative; 2) and agree to use appropriate contraceptive measures throughout the trial period and within 1 week after the last dose of trial drug, which must include at least one barrier contraceptive method; 3) and do not breastfeed. Male patients must meet: It must be agreed to use appropriate contraceptives throughout the trial, including at least one barrier contraceptive method. 5. Following background systemic standard treatments are permitted: (1) Before randomization, oral prednisone (or equivalent dose of glucocorticoid) = 8 weeks; (2) Before randomization, oral hydroxychloroquine sulfate = 8 weeks; 6. Sign the informed consent form, voluntarily participate in this project and can complete the follow-up as required.
Exclusion criteria
Exclusion criteria: 1. Systemic lupus erythematosus; RCLASI active score = 3 at screening and baseline. 2. Infection: (1) Latent or active tuberculosis or any previous history of tuberculosis. (2) Chronic infection. (3) Any infection requiring hospitalization, parenteral antimicrobial therapy or judged by the investigator as opportunistic within 6 months before the first administration of the study drug. (4) Any infection treated within 2 weeks. (5) History of recurrent (more than one attack) herpes zoster or disseminated (single attack) herpes zoster or disseminated (single attack) herpes simplex. (6) History or current symptoms of any lymphoproliferative disease, including cytomegalovirus or Epstein Barr virus related lymphoproliferative disease, lymphoma, leukemia, or signs and symptoms suggestive of current lymphoproliferative disease. 3. Within 6 months before randomization, patients with the following diseases: deep venous thrombosis, pulmonary embolism, thyroid disease, liver disease, malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction, cancer, tuberculosis, mental illness and other autoimmune diseases. The researcher's evaluation of no clinical significance can be excluded. 4. HIV positive, active hepatitis B virus positive (HBsAg or HBeAg positive) and HCV antibody positive at the time of screening. 5. Thalidomide and Tripterygium wilfordii were taken orally within 2 weeks before randomization; Take orally or inject any drugs for LEP, such as methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, azathioprine, biological agents, Chinese herbal medicine, etc. within 4 weeks before randomization; Phototherapy within 4 weeks before randomization. 6. Patients who have used JAK inhibitors and have a flushing period of less than 7 half-life; Previous treatment with the study drug or known intolerance to the study drug. 7.Those who participated in any drug or medical device clinical trial within 4 weeks before randomization. 8.Any condition, including laboratory examination, medical history or other screening evaluation results, that the investigator considers to pose an inappropriate risk or participate in the test contraindications or may interfere with the test objectives, conduct or evaluation. 9.Patients with drug abuse, alcoholism or mental disorders, unable to cooperate or adhere to treatment, poor predictive compliance; No legal capacity or limited legal capacity to provide informed consent or consent. 10. Abnormal blood cell analysis, including: (1) Hemoglobin 2 times the upper normal limit or serum creatinine > 3 times the upper normal limit. 12. Subjects taking potent cytochrome P450 3A4 enzyme inhibitors, such as ketoconazole. 13. Subjects taking medium cytochrome P450 3A4 enzyme inhibitors and cytochrome P450 2C19 inhibitors, such as Fluconazole. 14. Subjects taking potent cytochrome P450 3A4 enzyme inducers, such as Rifampin. 15. For any other reason, the researcher believes that it is not suitable to participate in this test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index;Cutaneous Lupus Erythematosus Disease Area and Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index;Physician's Global Assessment; | — |
Countries
China
Contacts
Public ContactQianjin Lu
Hospital for Skin Diseases, Institute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College
Outcome results
None listed