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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 56, and 60
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My weight is between 40 kg and 130 kg.
Select...
I have active lupus affecting my skin for at least 3 months with a CLASI-A score of 8 or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 56, and 60
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 56, and 60
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in type 1 IFN GS score in lesional skin at Week 12
Secondary outcome measures
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)
+3 moreSide effects data
From 2022 Phase 1 trial • 13 Patients • NCT0503740920%
Road traffic accident
20%
Intervertebral disc protrusion
20%
Vaccination site pain
20%
Thermal burn
20%
Abdominal pain lower
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
4,570 Previous Clinical Trials
10,915,958 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,092,173 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe lupus affecting my kidneys, needing strong medication.I have not had a major heart or stroke event, or serious lung blood clot in the last 6 months.I haven't had a serious infection or taken antibiotics in the last 2 months.I have severe brain lupus needing treatment in the last 2 months.I haven't had cancer in the last 5 years, except for specific skin cancers or early cervical cancer.My weight is between 40 kg and 130 kg.I have active lupus affecting my skin for at least 3 months with a CLASI-A score of 8 or more.I have had severe or repeated shingles or herpes outbreaks.I do not have any autoimmune or inflammatory diseases that could affect test results.I have a skin condition that is not CLE or SLE.I have hepatitis B or C, HIV, or untreated TB.I am willing to follow the study's procedures and agree to skin biopsies.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are adults aged 40 or older being included in the sample group for this research?
"Patients aged between 18 and 75 may be eligible for enrollment in this clinical trial. There are 23 sub-age studies available, as well as 119 ones that cater to seniors over the age of 65."
Answered by AI
Are there any current opportunities to take part in this clinical experiment?
"Per the information on clinicaltrials.gov, this specific trial is no longer actively seeking patients and has not been updated since June 21st 2023. Fortunately, there are 140 other medical studies that can be accessed right now for those eager to participate in a research project."
Answered by AI
May I participate in this research study?
"Patients with systemic lupus erythematosus aged between 18 and 75 are eligible to participate. The total number of participants being recruited is 48."
Answered by AI
Is Group 1 a reliable course of treatment for individuals?
"Our team at Power graded Group 1's safety as a 2, due to the lack of evidence on its efficacy despite some data supporting its safety."
Answered by AI
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