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A Phase II Study of M2951 in SLE | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Phase II Study of M2951 in SLE

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With SLE

NCT02975336•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligible male and female participants, aged 18 to 75 years
•Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
•SLEDAI-2K total score greater than or equal to (\>=) 6 (including clinical SLEDAI greater than or equal to (\>=) 4) at Screening Visit
•And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (\>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening

Exclusion Criteria

•Proteinuria (urine protein to creatinine ratio \[UPCR\] \> 4 mg/mg)
•Acutely worsened renal function
•Central nervous system SLE
•Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 30 mg daily prednisone equivalent
•Use of injectable corticosteroids, or change in dose of corticosteroids.

Locations (157)

Pinnacle Research Group LLC

Anniston, Alabama, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Mesa, Arizona, United States

Arizona Arthritis & Rheumatology Associates, P.C.

Phoenix, Arizona, United States

Advanced Research Center, Inc.

Anaheim, California, United States

Wallace Rheumatic Study Center

Beverly Hills, California, United States

Medvin Clinical Research

Covina, California, United States

Southern California Permanent Medical Group

Fontana, California, United States

Global Research Management

Glendale, California, United States

University of Southern California

Los Angeles, California, United States

East Bay Rheumatology Medical Group, Inc.

San Leandro, California, United States

Key Dates

Start Date

January 4, 2017

Primary Completion Date

November 27, 2019

Completion Date

March 23, 2020

Last Updated

April 12, 2021

Enrollment

469

ACTUAL participants

Conditions

Systemic Lupus Erythematosus

Interventions

Placebo

DRUG

M2951

DRUG

M2951

DRUG

M2951

DRUG

M2951

DRUG

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITINGPHASE1

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

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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: April 12, 2021Data 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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A Phase II Study of M2951 in SLE

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Diseases (ARD)

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

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