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A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

NCT03845517•Pfizer

View on ClinicalTrials.gov

Summary

Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Male and/or female subjects between ≥18 and ≤75 years of age inclusive.
•Diagnosis of moderate to severe active Lupus.
•Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.

Exclusion Criteria

•Active renal lupus
•Severe active central nervous system (CNS) lupus
•Have cancer or a history of cancer within 5 years of screening.
•Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus.
•Active bacterial, viral, fungal, mycobacterial or other infections
•Psychiatric condition including recent or active suicidal ideation or behavior
•Have active fibromyalgia/myofascial/chronic pain.
•Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.

Locations (164)

UAB Department of Medicine Clinical Research Enterprise

Birmingham, Alabama, United States

The Kirklin Clinic

Birmingham, Alabama, United States

UAB Hospital Department of Pharmacy

Birmingham, Alabama, United States

UAB Hospital-Clinical Research Unit (CRU)

Birmingham, Alabama, United States

The University of Alabama at Birmingham

Birmingham, Alabama, United States

UAB Department of Medicine Clinical Research Enterprise

Birmingham, Alabama, United States

St. Joseph Heritage Healthcare

Fullerton, California, United States

Advanced Medical Research, LLC

La Palma, California, United States

Arthritis and Osteoporosis Medical Center

La Palma, California, United States

Desert Medical Advances

Palm Desert, California, United States

Key Dates

Start Date

April 18, 2019

Primary Completion Date

October 5, 2023

Completion Date

October 5, 2023

Last Updated

September 5, 2024

Enrollment

350

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

Placebo

DRUG

PF-06700841 15 mg

DRUG

PF-06700841 30 mg

DRUG

PF-06700841 45 mg

DRUG

Sponsors

Lead Sponsor

Pfizer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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