400
Participants
Start Date
April 15, 2024
Primary Completion Date
November 30, 2026
Study Completion Date
November 30, 2026
Amlitelimab
"IP will be administered subcutaneously by the Investigator or designee as follows:~* Amlitelimab or~* Matching placebo"
BI 1015550 (Nerandomilast)
Study participants will take the active investigational product BI 1015550 (Nerandomilast) or matching placebo provided as film-coated tablets, administered orally BID.
Placebo
see Experimental Arm intervention description
RECRUITING
Hospital for Special Surgery, New York
RECRUITING
Columbia University Medical Center, New York
RECRUITING
Northwell Health, Great Neck
NOT_YET_RECRUITING
University of Pittsburgh Medical Center, Pittsburgh
RECRUITING
University of Pennsylvania, Philadelphia
NOT_YET_RECRUITING
Thomas Jefferson University Hospital, Philadelphia
WITHDRAWN
Temple University Hospital, Philadelphia
RECRUITING
Georgetown University Medical Center - Department of Rheumatology, Washington D.C.
RECRUITING
Johns Hopkins University School of Medicine, Baltimore
NOT_YET_RECRUITING
Duke University Medical Center, Durham
RECRUITING
Medical University of South Carolina (MUSC), Charleston
RECRUITING
Emory University School of Medicine, Atlanta
RECRUITING
University of Alabama - Division of Pulmonary and Critical Care Medicine, Birmingham
WITHDRAWN
Meharry Medical College, Nashville
NOT_YET_RECRUITING
Vanderbilt University Medical Center, Nashville
WITHDRAWN
Cleveland Clinic, Cleveland
RECRUITING
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee
RECRUITING
Mayo Clinic, Rochester
RECRUITING
Northwestern University, Chicago
RECRUITING
The University of Chicago Medical Center (UCMC), Chicago
WITHDRAWN
Washington University School of Medicine, St Louis
RECRUITING
University of Kansas School of Medicine, Kansas City
RECRUITING
University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics, Houston
WITHDRAWN
The University of Utah Health Sciences Center, Salt Lake City
RECRUITING
Keck School of Medicine at USC Medical Center, Los Angeles
RECRUITING
Cedars-Sinai Medical Center, Los Angeles
RECRUITING
Stanford University Medical Center, Palo Alto
RECRUITING
Oregon Health & Science University (OHSU), Portland
NOT_YET_RECRUITING
University of California, Los Angeles (UCLA) Ronald Reagan Medical Center, Los Angeles
WITHDRAWN
Yale University School of Medicine - Epilepsy, New Haven
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
Boston University (BU), Boston
RECRUITING
University of Michigan, Ann Arbor
RECRUITING
Robert Wood Johnson Medical School, New Brunswick
Collaborators (2)
Sanofi
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Scleroderma Research Foundation, Inc.
OTHER