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 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.

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

Eligibility last updated 7/24/23. 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

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
.
CLS-20555723

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