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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 weeks
Treatment ~ Varies
Follow Up ~baseline through week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 56 for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 194 Patients • NCT04092452
13%
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

PF-06700841 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03845517 — Phase 2
Lupus Research Study Groups: PF-06700841 45 mg, PF-06700841 30 mg, Placebo, PF-06700841 15 mg
Lupus Clinical Trial 2023: PF-06700841 Highlights & Side Effects. Trial Name: NCT03845517 — Phase 2
PF-06700841 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03845517 — Phase 2
~58 spots leftby May 2025