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MSC2364447C Phase 1b in Systemic Lupus Erythematosus | Clinical Trials | Clareo Health

COMPLETEDPHASE1

MSC2364447C Phase 1b in Systemic Lupus Erythematosus

A Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus Erythematosus

NCT02537028•EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C administered for 4 weeks in systemic lupus erythematosus subjects (SLE).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female of 18 to 65 years of age
•Diagnosis of systemic lupus erythematosus (SLE) (at least 4 of the 11 American College of Rheumatology \[ACR\] classification criteria for SLE) of at least 6 months duration at the Screening visit
•Positive test results for anti-nuclear antibody (ANA) (human epithelial cell-2 ANA greater than or equal to \[\>=\] 1:80) and/or anti-dsDNA antibody (\>= 30 international units per milliliter \[IU/mL\]) at the Screening visit
•At least 1 SLE disease manifestation (assessed by Systemic Lupus Erythematosus Disease Activity Index-2000 \[SLEDAI-2K\]) other than positive antidsDNA and no central nervous system (CNS) SLE (psychosis, organic brain syndrome, cranial nerve disorder, lupus headache, or new-onset cerebrovascular accident)
•History of vaccinations as follows or vaccination against these pathogens during Screening:
•1. Vaccination against Streptococcus pneumoniae with pneumococcal polysaccharide vaccine 23 or pneumococcal 13-valent conjugate vaccine as per local guidelines, and
•2. Vaccination against influenza virus (as per local seasonal recommendations). Subjects receiving 1 or more of these vaccinations during screening must have at least 2 weeks between the vaccination(s) and the date of randomization at Day 1.

Exclusion Criteria

•Active clinically significant CNS SLE
•Initiation or change in dose of anti-malarial treatment after the screening visit
•Within 2 weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 40 mg daily prednisone equivalent, use of any injectable corticosteroids, or change in dose of corticosteroids
•Within 2 weeks prior to Screening, initiation or change in dose of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, or nonsteroidal anti-inflammatory drugs (NSAIDs).
•Within 2 months prior to Screening or during Screening: initiation of or change in dose of methotrexate, mycophenolate (mofetil or sodium), or azathioprine
•Within 2 months prior to Screening or during Screening, use of cyclosporine, tacrolimus, leflunomide, abatacept, anti-tumor necrosis factor alpha agents, intravenous immunoglobulin, plasmapheresis, or other disease-modifying, immunosuppressive, or immunomodulatory therapies not otherwise specified in protocol
•Within 6 months prior to Screening or during Screening: use of cyclophosphamide or chlorambucil
•Within 12 months prior to screening or during screening: use of rituximab, belimumab, or any other B cell-depleting or modulating therapies
•Within 1 month prior to Screening or during Screening, vaccination with live or live-attenuated virus vaccine.
•Active clinically significant viral, bacterial or fungal infection, or any serious episode of infection requiring hospitalization within the last 6 months - Estimated glomerular filtration rate by the Modification of Diet in Renal Disease equation of less than (\<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2), or recent decline in kidney function, or proteinuria \>= 3 gram per day (g/day) (spot urine protein/creatinine ratio \>= 3 mg/mg)

Locations (13)

Research site

Anniston, Alabama, United States

Research site

El Cajon, California, United States

Research site

Lakewood, California, United States

Research site

Los Angeles, California, United States

Research site

Clearwater, Florida, United States

Research site

DeBary, Florida, United States

Research site

Orlando, Florida, United States

Research site

Grand Blanc, Michigan, United States

Research site

St Louis, Missouri, United States

Research site

Austin, Texas, United States

Key Dates

Start Date

November 30, 2015

Primary Completion Date

October 4, 2016

Completion Date

October 4, 2016

Last Updated

October 9, 2017

Enrollment

ACTUAL participants

Conditions

Lupus Erythematosus, Systemic

Interventions

MSC2364447C

DRUG

MSC2364447C

DRUG

Placebo

DRUG

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

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RECRUITINGPHASE3

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

NCT07438496

Lupus Erythematosus, Systemic

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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: October 9, 2017Data 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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MSC2364447C Phase 1b in Systemic Lupus Erythematosus

Inclusion Criteria

Exclusion Criteria

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus

Exploratory Clinical Study of CNCT19 Anti CD19 Cell Therapy in the Treatment of Refractory Autoimmune Diseases