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Investigating PF-06823859 in Adults with Skin Symptoms of Lupus

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

Phase 2 Interventional Pfizer · NCT05879718

This study is testing a new medication to see if it can help adults with skin symptoms of lupus feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment48 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorPfizer Industry-sponsored
Locations36 sites (Birmingham, Alabama and 35 other locations)
Trial IDNCT05879718 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effects and safety of PF-06823859 in adults diagnosed with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) who exhibit skin symptoms. Participants will be randomly assigned to receive either the active medication or a placebo through intravenous infusion. The study will assess the participants' responses over a 16-week period, with those not responding to placebo potentially receiving the active medication. The focus is on understanding how the medication is processed in the body and its impact on skin symptoms associated with lupus.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed active CLE or SLE and a CLASI-A score of at least 8.

Not a fit: Patients with skin disorders other than CLE or SLE, or those with severe lupus nephritis or central nervous system involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from skin symptoms related to lupus.

How similar studies have performed: While this approach is novel, similar studies targeting lupus symptoms have shown promise, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Where this trial is running

Birmingham, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus Erythematosus, SystemicLupus Erythematosus, Cutaneoustype 1 IFN gene signature, SLE, CLE
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.