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A DOSE-RANGING STUDY TO EVALU...

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

Last Updated: 2024-09-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-18

Study Completion Date

2023-10-05

Brief Summary

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

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

PF-06700841 15 mg

Group Type EXPERIMENTAL

PF-06700841 15 mg

Intervention Type DRUG

PF-06700841 15 mg

PF-06700841 30 mg

Group Type EXPERIMENTAL

PF-06700841 30 mg

Intervention Type DRUG

PF-06700841 30 mg

PF-06700841 45 mg

Group Type EXPERIMENTAL

PF-06700841 45 mg

Intervention Type DRUG

PF-06700841 45 mg

Interventions

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Placebo

Intervention Type DRUG

PF-06700841 15 mg

Intervention Type DRUG

PF-06700841 30 mg

Intervention Type DRUG

PF-06700841 45 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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