Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT05879718
Eligibility Criteria:
Inclusion Criteria:
* Have a histologically confirmed active CLE or SLE with cutaneous manifestations in the form of subacute cutaneous lupus erythematosus or/and discoid/chronic cutaneous lupus erythematosus at least 3 months and CLASI-A at least 8 or higher.
* Participant has adequate intravenous infusion access per investigator's judgement
* Willing to comply with study procedures including skin punch biopsies procedures.
* Weight is greater than 40 kg and less than 130 kg.
Exclusion Criteria:
* Skin disorders other than CLE or SLE.
* Active, severe lupus nephritis requiring treatment with cytotoxic agents or high-dose steroids.
* Active severe central nervous system lupus requiring therapeutic intervention within 60 days of baseline.
* Cancer or a history of cancer within 5 years of screening except adequately resected basal or squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix.
* Known history of a major cardiovascular or cerebrovascular event within 24 months, pulmonary arterial hypertension, pulmonary embolism within 6 months of screening.
* Have any autoimmune or inflammatory disease that would interfere with interpretation of test results or clinical assessments.
* History of disseminated herpes zoster/simplex or recurrent herpes zoster.
* Serious infection within 60 days of baseline or an active infection treated with oral antibiotics within 14 days of baseline.
* Have evidence of active or latent infection of hepatitis B or C, known history of human immunodeficient virus (HIV) infection, or infected with Mycobacterium TB (active or latent TB)
* Laboratory abnormalities that meet exclusion criteria at the Screening visit. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05879718
Study Brief:
Protocol Section:
NCT05879718