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Monoclonal Antibodies

PF-06823859 for Systemic Lupus Erythematosus

Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight is greater than 40 kg and less than130 kg.
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.
Must not have
Active, severe lupus nephritis requiring treatment with cytotoxic agents or high-dose steroids.
History of disseminated herpes zoster or disseminated herpes simplex or recurrent localized, dermatomal herpes zoster.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60

Summary

This trial is researching if a drug, PF-06823859, is safe and effective for adults with CLE or SLE and skin symptoms. 48 participants will receive active study medicine or placebo for 65 weeks of study.

Who is the study for?
Adults over 18 with active CLE or SLE and skin symptoms, a CLASI-A score of at least 8, weighing between 40-130 kg can join. They must have confirmed lupus skin manifestations for at least 3 months and be willing to undergo study procedures like skin biopsies. Exclusions include recent serious cardiovascular events, severe infections, other autoimmune diseases that could affect results, certain cancers within the last five years.
What is being tested?
The trial is testing PF-06823859 against a placebo in adults with lupus affecting the skin. Participants will receive treatments via intravenous infusion. The goal is to see if PF-06823859 improves their condition compared to those who receive no drug (placebo). The study includes initial treatment, long-term extension period and follow-up totaling approximately 65 weeks.
What are the potential side effects?
Specific side effects are not listed but generally may include reactions related to intravenous infusions such as discomfort at injection site or allergic reactions; potential impacts on organ function due to medication; fatigue; or exacerbation of existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My weight is between 40 kg and 130 kg.
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I have active lupus affecting my skin for at least 3 months with a CLASI-A score of 8 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe lupus affecting my kidneys, needing strong medication.
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I have had severe or repeated shingles or herpes outbreaks.
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I do not have any autoimmune or inflammatory diseases that could affect test results.
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I have a skin condition that is not CLE or SLE.
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I have hepatitis B or C, HIV, or untreated TB.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, 8, 12, 16, 20, 24, 32, 40, 48, and 60 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in type 1 IFN GS score in lesional skin at Week 12
Secondary study objectives
Achieving ≥50%, 4 or 7 points reduction in CLASI-A (over time)
Change from baseline in CLASI-A score (over time)
Change from baseline in Physician global assessment (PhGA) (over time)
+2 more

Side effects data

From 2022 Phase 1 trial • 13 Patients • NCT05037409
20%
Intervertebral disc protrusion
20%
Vaccination site pain
20%
Road traffic accident
20%
Abdominal pain lower
20%
Thermal burn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: PF-06823859 300 mg
Cohort 2: PF-06823859 900 mg
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1Experimental Treatment1 Intervention
PF-06823859
Group II: Group 2Placebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06823859
2016
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,134 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,990 Total Patients Enrolled

Media Library

PF-06823859 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05879718 — Phase 2
Lupus Research Study Groups: Group 1, Group 2
Lupus Clinical Trial 2023: PF-06823859 Highlights & Side Effects. Trial Name: NCT05879718 — Phase 2
PF-06823859 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05879718 — Phase 2
~18 spots leftby Dec 2025
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