Cutaneous lupus erythematosus
Conditions
Interventions
Anifrolumab:aPFS and drug-device combination products of anifrolumab
placebo group:aPFS and drug-device combination products of placebo
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and/or female participant must be 18 to 70 years of age inclusive, at the time of signing the ICF. 2. Body weight >= 40.0 kg. 3. Participants must have a confirmed diagnosis of chronic CLE (including discoid CLE and other subtypes) and/or subacute CLE with or without systemic manifestation. Note: Acute CLE manifestations may coexist if they occur in patients with predominantly chronic and/or subacute CLE. 4. Meets all of the following TB criteria: (a) No medical history or signs or symptoms of active TB prior to or during Screening Visit. (b) Chest radiograph (obtained during Screening or within 12 weeks prior to signing of the ICF) or a CT scan of the chest (within 12 weeks of signing the ICF) with no evidence of active or signs of prior TB infection. (c) No recent contact with a person with active TB OR if there has been such contact, referral to a physician specializing in TB to undergo additional evaluation prior to randomization (documented comprehensively in source), and, if warranted, receipt of appropriate treatment for latent TB initiated before the first administration of study intervention. (d) No history of latent TB prior to initial Screening Visit, with the exception of latent TB with documented completion of appropriate treatment. 5. The participant must undergo an IFN-? release assay IGRA (eg, QFT-G test) test for TB obtained from the study central laboratory at Screening with any of the following results; 6. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 7. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this CSP. 8. Provision of signed and dated written Optional Genomics Research Information and Consent Form prior to collection of samples for optional genomics initiative research that supports the Genomic Initiative (see Appendix E 2). 9. Females who have been or are sexually active with an intact cervix must have documentation of a cervical cancer screening as per local guidelines (Pap smear or HPV tests, see Appendix G) with a normal test result within 2 years prior to randomization. Any abnormal cervical cancer screening result documented within 2 years prior to randomization must be repeated to confirm participant eligibility. 10. Any negative antigen or PCR test result (local or central laboratories as appropriate) as per local policies at Screening, in addition to no known or suspected COVID-19 exposure within 2 weeks prior to Screening based on the COVID-19 questionnaire.
Exclusion criteria
Exclusion criteria: 1. As judged by the Investigator, any medical condition which in the Investigator’s opinion makes participation in the study undesirable. 2. Known history of drug or alcohol abuse, as confirmed by the Investigator, within 1 year of signing main ICF. 3. History or evidence of suicidal ideation (severity of 4 [active: method and intent, but no plan] or 5 [active: method, intent, and plan]) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the C-SSRS at Screening. 4. Severe or life-threatening SLE, including, but not limited to, eg, active nephritis, central nervous system disease, and severe systemic vasculitis. 5. Active SLE or Sjögren’s Syndrome that requires, or is likely to require, during the study the use of a prohibited medication or a restricted medication at above protocol permitted doses. 6. Any active skin conditions other than chronic or subacute CLE that may interfere with the study (eg, psoriasis, eczema, skin vasculitis (vasculitis associated with CLE lesions is acceptable), dermatomyositis rash, lupus pernio/sarcoidosis, or well-documented, drug-induced lupus). 7. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 24 weeks). 8. Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV infection confirmed by central laboratory at Screening. Participants refusing HIV testing during the Screening Period will not be eligible for the study. 9. Confirmed positive test for hepatitis B serology for: (a) HbsAg, OR (b) HbcAb AND HBV DNA detected above the LLOQ by reflex testing by the central laboratory at Screening. 10. Active hepatitis C infection (defined as positive HCV antibody and detectable HCV RNA as confirmed by central laboratory). 11. Any severe case, of herpes zoster infection at any time prior to randomization (Day 1), including, but not limited to, non-cutaneous herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes involving the retina (ever). 12. Any herpes zoster infection that has not completely resolved within 12 weeks prior to signing the ICF. 13. Any clinical CMV or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF. 14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization (Day 1). 15. Any of the following: (a) Clinically significant chronic infection (ie, osteomyelitis, bronchiectasis, etc) within 8 weeks prior to signing the ICF (chronic nail infections are allowed). (b) Any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF. 16. Any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to randomization (Day 1). 17. History of cancer, or suspicion of recent malignancy apart from: (a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy = 3 months prior to randomization (Day 1). (b) Cervical cancer in situ treated with apparent success with curative therapy = 1 year prior to randomization (Day 1). 18. COVID-19: (a) Any history of severe COVID-19 infection (eg, prolonged hospit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CLA-IGA-R erythema response at Week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| CLASI-A scale/hypertrophy score;CLASI-70 response;Total CLASI-A erythema score; | — |
Countries
China
Contacts
Public ContactMeng Pan
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed