A Study to Learn About the Study Medicine (PF-06823859) in Adults With Active CLE or SLE With Skin Symptoms

Overview

About this study

The purpose of this study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 07/03/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Sluzevich, M.D.

Open for enrollment

Contact information:

Clinical Studies Unit

(904) 953-2255

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Open for enrollment

Contact information:

Aaron Mangold M.D.

Mangold.Aaron@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20555723

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