Daratumumab in Primary Antiphospholipid Syndrome

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 26, 2023

Primary Completion Date

June 24, 2026

Study Completion Date

March 31, 2027

Conditions
Autoimmune Disorders
Interventions
BIOLOGICAL

Daratumumab

Participants will receive 4 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48

BIOLOGICAL

Daratumumab

Participants will receive 4-8 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48

BIOLOGICAL

Daratumumab

Participants will receive 4-16 mg/kg of intravenous (IV) daratumumab administered weekly for 8 doses (weeks 0 through 7). Post-treatment follow-up visits will occur at weeks 9, 12, 18, 24, 36, and 48

Trial Locations (8)

10016

RECRUITING

NYU Langone, New York

10021

RECRUITING

Hospital for Special Surgery, New York

RECRUITING

Weill Cornell, New York

11021

RECRUITING

Northwell Health, Great Neck

21205

RECRUITING

Johns Hopkins University, Baltimore

27710

RECRUITING

Duke University, Durham

48109

RECRUITING

University of Michigan, Ann Arbor

55905

RECRUITING

Mayo Clinic Rochester, Rochester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Immune Tolerance Network (ITN)

NETWORK

collaborator

PPD Development, LP

INDUSTRY

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH