A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms.
Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring type 1 IFN gene signature
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 study procedures including skin punch biopsies procedures. Weight is greater than 40 kg and less than130 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 cutaneous basal cells, squamous cell carcinoma, or carcinoma in situ of uterine cervix. Known history of a major cardiovascular or cerebrovascular event, pulmonary arterial hypertension, pulmonary embolism within 6 months Have any autoimmune or inflammatory disease that would interfere with interpretation of test results or clinical assessments. History of disseminated herpes zoster or disseminated herpes simplex or recurrent localized, dermatomal herpes zoster. Serious infection within 60 days of baseline or an active infection treated with oral anti-biotics 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 without adequately treatment Laboratory abnormalities 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.
Sites / Locations
- DermEffectsRecruiting
- Oshawa Clinic Dermatology Trials
- Dermatology on Bloor - Research Toronto
- Alpha Recherche Clinique
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group 1
Group 2
PF-06823859
Placebo