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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL



Official Title: A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF-06823859 IN ADULT PARTICIPANTS WIT

Brief Summary:

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.

This study is seeking for participants who:

  • are adults of 18 years of age or older.
  • are confirmed to have CLE or SLE with some symptoms of the skin.
  • have a cutaneous LE disease area and severity index activity (CLASI-A) score at least 8.

About 48 participants will be selected to receive active study medicine (PF-06823859) or placebo (an infusion without drug).
About 32 are grouped to receive the active study medicine and 16 are to receive placebo.
They will be receiving the treatments by intravenous infusion (injected directly into the veins).

At week 16, participants receiving the active study medicine and non-clinical responders from placebo will receive the active study medicine.
The placebo clinical responders will continue to receive placebo till Week 40.
All participants will have last follow-up visit at Week 60.

The study will compare participants receiving PF-06823859 to participants who receive placebo.
This will help us see if PF-06823859 is safe and effective to treat CLE or SLE and improve the CLASI-A score.
Participants will take part in this study for about 65 weeks.
This includes up to a 5-week selection period, a 12-week start of treatment period, a 36-week long term extension treatment period, and a 12-week follow-up period.