Pfizer Ends Mid-Stage Lupus Skin Trial, Trimming a Small but Promising Autoimmune Option

Pfizer Inc (PFE) announced an update on their ongoing clinical study.

Study Overview

Pfizer is running a Phase 2 trial called “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 WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS.” The study looks at whether its drug PF-06823859 can safely improve skin symptoms in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) with skin involvement. The main goal is to see if the drug reduces disease severity scores on a standard skin lupus index while maintaining a manageable safety profile, a key step in building a lupus-focused franchise.

Intervention/Treatment

The trial tests PF-06823859, an investigational drug given by intravenous infusion, against a placebo infusion. PF-06823859 is designed to reduce skin inflammation and lesions in lupus, aiming to improve quality of life for patients who often have few effective options and high unmet need.

Study Design

This is a randomized, placebo-controlled, parallel-group study. About 48 adults are assigned in a 2:1 ratio to receive either PF-06823859 or placebo. The trial is “triple blind,” meaning participants, trial doctors, and outcome assessors do not know who is on active treatment or placebo during the main assessment period. The primary purpose is treatment: to see if PF-06823859 works better than placebo on skin disease scores and to understand its safety and drug levels in the body.

Study Timeline

The study was first submitted on 18 May 2023. Participants are tracked for roughly 65 weeks, including screening, treatment, and follow-up. The last full assessments are planned at Week 48, with final follow-up at Week 60. Pfizer most recently updated the trial record on 12 January 2026, indicating that key design and status information has been refreshed and that the project has reached an important development checkpoint, even though it is now listed as terminated rather than ongoing.

Market Implications

The termination of this Phase 2 lupus skin study is a modest negative signal for Pfizer’s immunology pipeline, as it removes a potential future asset in a high-need autoimmune niche. For investors, the update suggests that near- to mid-term lupus revenues from PF-06823859 are now off the table, which may slightly weigh on sentiment toward Pfizer’s longer-term growth options beyond its core vaccine and oncology lines. However, lupus is a complex, high-risk area where clinical failures are common, and larger players such as GSK and AstraZeneca remain active with competing approaches. Given the small trial size and early stage, the financial impact should be limited and more sentiment-driven than model-driven, with investors likely to focus on whether Pfizer reallocates R&D capital into higher-probability autoimmune or oncology programs.

The study has been updated and is now listed as terminated, with further details available on the ClinicalTrials portal.

To learn more about PFE’s potential, visit the Pfizer Inc drug pipeline page.