Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)

PHASE2TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

October 13, 2021

Primary Completion Date

January 4, 2024

Study Completion Date

January 4, 2024

Conditions
IgG4 Related DiseaseIgG4-RD
Interventions
DRUG

elotuzumab

Elotuzumab is a humanized recombinant monoclonal antibody (mAb) targeted against SLAMF7, a cell surface glycoprotein.

DRUG

placebo for elotuzumab

The placebo for elotuzumab is 0.9% sterile normal saline for injection.

DRUG

methylprednisolone

Premedication administered intravenously, 45 to 90 minutes prior to each elotuzumab/placebo infusion, per protocol. Dosage in milligrams (mg).

DRUG

diphenhydramine

Premedication administered orally or intravenously, 45 to 90 minutes prior to each elotuzumab/placebo infusion, per protocol. Dosage in milligrams (mg).

DRUG

acetaminophen

Premedication administered orally, 45 to 90 minutes prior to each elotuzumab/placebo infusion, per protocol. Dosage in milligrams (mg).

DRUG

famotidine

Premedication administered orally or intravenously, 45 to 90 minutes prior to each elotuzumab/placebo infusion, per protocol. Dosage in milligrams (mg).

DRUG

prednisone

Prescribed dosing with prednisone begins on the day of the first elotuzumab/placebo infusion, administered orally. The ten-week dosing taper proceeds, per protocol. Dosage in milligrams (mg).

Trial Locations (3)

30322

Emory Healthcare, Atlanta

55905

Mayo Clinic: Pulmonary and Critical Care Medicine, Rochester

02114

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Autoimmunity Centers of Excellence

OTHER

collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT04918147 - Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) | Biotech Hunter | Biotech Hunter