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Lupus Erythematosus, SystemicPhase 2NCT05879718

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

A Phase 2 study testing PF-06823859 in people with Lupus Erythematosus, Systemic and Lupus Erythematosus, Cutaneous, run by Pfizer at 19 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
PF-06823859
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
19 sitesin 4 countries
Study dates
7 Jul 2023to 18 Nov 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

19 sites in 4 countries.

19 sites in 4 countries

United States11 sites

  • Emory University

    Atlanta, Georgia, 30322

  • The Kirklin Clinic of UAB Hospital

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham, Department of Dermatology

    Birmingham, Alabama, 35233

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35249

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The University of Kansas Hospital

    Kansas City, Kansas, 66160

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Dermatology Research Associates

    Los Angeles, California, 90045

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Mayo Clinic in Arizona - Scottsdale

    Scottsdale, Arizona, 85259

Other trials in United States

Canada3 sites

  • DermEffects

    London, Ontario, N6H 5L5

  • Dermatology on Bloor - Research Toronto

    Toronto, Ontario, M4W 2N4

  • Whitby Health Centre

    Whitby, Ontario, L1P 0p9

Other trials in Canada

Greece3 sites

  • Dermatological and Venereological Hospital Andreas Syggros

    Athens, 161 21

  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

    Chaïdári, Attikí, 124 62

  • Ionos Dragoumi 5 Kaisariani

    Kaisarianí, Attikí, 16121

Other trials in Greece

Spain2 sites

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

About this study

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 WITH ACTIVE CLE OR SLE WITH CUTANEOUS MANIFESTATIONS

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:

Read more
  • are adults of 18 years of age or older.
  • are confirmed to have CLE or SLE with involvement of the skin.
  • have a Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score of 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 all participants receiving the active study drug since day 1 and participants who have received placebo since day 1 and are not responding clinically will receive active study medication. Patients who have received placebo since Day 1 and who have had a clinical response 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 with skin symptoms and improve participant's 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 Q4Wk treatment period, a 36-week Q8Wk treatment period, and a 12-week follow-up period.

Being tested
Placebo, PF-06823859
Keywords
type 1 IFN gene signature, SLE, CLE
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo (intravenous infusion)

  • PF-06823859Drug

    PF-06823859 (intravenous infusion)

Study groups in NCT05879718
Study groupRoleWhat they receive
Group 1ExperimentalPF-06823859
Receives: Drug: PF-06823859
Group 2Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12

    Change from baseline GS was calculated as GS(t) - GS(0), where GS(t) was the gene signature score at Week 12 and GS(0) was the gene signature score at Baseline, where the GS(t) was calculated as the mean of log2 transformed counts per million reads from each of 13 genes in RNAseq, the higher GS indicated coordinated higher expression. There is no minimum/maximum limit to the GS score. Gene expression was quantified using RNA sequencing and summarized as log2-transformed counts per million mapped reads [log2(CPM)]. Higher values indicate higher normalized gene expression and without a bounded scale or defined minimum or maximum value.

    Measured: Baseline, Week 12

Secondary outcomes (11)

  1. Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score at Week 12

    CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease.

    Measured: Baseline, Week 12

  2. Percent Change From Baseline in CLASI-A Score at Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60

    CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.

    Measured: Baseline, Weeks 4, 8, 16, 20, 24, 32, 40, 48 and 60

  3. Change From Baseline in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

    CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.

    Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

  4. Percentage of Participants With Greater Than or Equal to (>=) 50 Percent Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

    CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with >=50 percent reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

  5. Percentage of Participants With >=4 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

    CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with >=4 points reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

  6. Percentage of Participants With >=7 Points Reduction in CLASI-A Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

    CLASI-A measures erythema and scaling or hypertrophy in thirteen skin regions. CLASI-A scores ranges from 0 to 70, with higher scores indicating more severe skin disease. Percentage of participants with >=7 points reduction in CLASI-A score at the specified timepoints was reported in this outcome measure. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.

    Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

  7. Change From Baseline in Physician Global Assessment (PhGA) Score at Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

    PhGA score was assigned by physician as the number within the 0 to 100 millimeter range on visual assessment scale and provided a global characterization of disease. Higher scores indicating more severe disease. Participants receiving PF-06823859 continued Q4W then Q8W treatment, while both participants receiving placebo switched to PF-06823859 at Week 16. Results are reported by treatment sequence to reflect protocol pathways and maintained the initial randomized comparison.

    Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48 and 60

  8. Number of Participants With Laboratory Test Abnormalities of Grade 3 or More According to Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0

    Laboratory test included activated partial thromboplastin time prolonged, alanine aminotransferase increased, alkaline phosphatase increased, anemia, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase (CPK) increased, cholesterol high, creatinine increased, hemoglobin increased, hypercalcemia, hyperkalemia, hypernatremia, hypertriglyceridemia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Laboratory test abnormalities were graded according to CTCAE v5.0; grade 3=severe, grade 4=life-threatening consequences and grade 5=death. Participants with any laboratory abnormalities of CTCAE v5.0 grade 3 or more were reported in this outcome measure.

    Measured: For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60

  9. Number of Participants With Clinically Significant Vital Signs Abnormalities

    Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR). Clinically significant vital signs abnormalities were based on investigator's decision.

    Measured: For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60

  10. Number of Participants With Clinically Significant Electrocardiogram (ECG) Results

    ECG parameters included PR interval, QRS duration and QT interval using Fridericia's formula (QTcF) interval. Clinically significant abnormalities in ECG parameters were based on investigator's decision.

    Measured: For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60

  11. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and Who Discontinued Study Due to TEAEs

    An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were the AEs with onset dates on or after the start of the study intervention up to after last dose of study intervention. An serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or any other pre-specified criteria in protocol of the study or other important medical events. AEs included SAEs (if occurred) and all other AEs (including non-SAEs).

    Measured: For Q4W arms: Day 1 up to pre-dose of Week 16; for Q8W arms: from dosing of Week 16 to Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2023
  2. Study start7 Jul 2023
  3. Primary completion5 Jun 2025
  4. Study completion18 Nov 2025

Why it stopped: Pfizer has made an internal business decision to not continue this study. This decision was not due to safety concerns or clinical effect reasons or requests from any regulatory authorities.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
About 48 eligible participants will be randomized in a 2:1 ratio to receive either PF-06823859 or placebo. Following assessments for the primary endpoint at Week 12, participants who are receiving active PF-06823859 or who are placebo non responders (responder is defined by ≥4 point reduction from the baseline in CLASI-A score) will receive PF-06823859 beginning at Week 16, while placebo responders will continue to be in the placebo group. The last dose of study intervention will be administered at Week 40 followed by last full study assessments at Week 48. The final follow up visit will be conducted at Week 60.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05879718
Sponsor's protocol ID
C0251013
Other IDs
2023-503343-33-00, 2023
Status last verified
Jul 2026
First submitted
18 May 2023
Last updated
11 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06823859 in people with Lupus Erythematosus, Systemic and Lupus Erythematosus, Cutaneous, run by Pfizer at 19 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada, Greece, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05879718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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