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Monoclonal Antibodies
PF-06700841 30 mg for Lupus
Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 56
Awards & highlights
Study Summary
This trial is assessing the efficacy of PF-06700841 in treating moderate to severe active SLE in patients who have failed to respond to standard of care.
Eligible Conditions
- Lupus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI-4) at Week 52.
Secondary outcome measures
Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52.
Change from baseline in the total scores of the Lupus Quality of Life (LupusQoL) at Week 52.
Number of clinically significant abnormalities in clinical laboratory values.
+10 moreSide effects data
From 2022 Phase 2 trial • 194 Patients • NCT0409245213%
Blood creatine phosphokinase increased
13%
Hidradenitis
9%
Acne
6%
Nausea
6%
Headache
2%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-06826647 400mg QD
Placebo
PF-06650833 400mg QD
PF-06700841 45mg QD
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-06700841 45 mgExperimental Treatment1 Intervention
PF-06700841 45 mg
Group II: PF-06700841 30 mgExperimental Treatment1 Intervention
PF-06700841 30 mg
Group III: PF-06700841 15 mgExperimental Treatment1 Intervention
PF-06700841 15 mg
Group IV: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06700841 30 mg
2019
Completed Phase 2
~350
PF-06700841 15 mg
2019
Completed Phase 2
~350
PF-06700841 45 mg
2019
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,580 Previous Clinical Trials
14,633,853 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,485 Previous Clinical Trials
11,810,728 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have moderate to severe active Lupus.You have active chronic pain, including fibromyalgia and myofascial pain syndrome.You have a mental health condition that includes thoughts or actions of hurting yourself.You have a serious and active case of lupus that affects your brain and nervous system.
Research Study Groups:
This trial has the following groups:- Group 1: PF-06700841 45 mg
- Group 2: PF-06700841 30 mg
- Group 3: Placebo
- Group 4: PF-06700841 15 mg
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.
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