A Study in Subjects With Late Prodromal & Early Manifest HD to Assess the Safety, Tolerability, pk, and Efficacy of Pepi

PHASE2CompletedINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

August 31, 2020

Study Completion Date

August 31, 2020

Conditions
Huntington's Disease
Interventions
DRUG

VX15/2503

VX15/2503 (pepinemab) is a humanized IgG4 monoclonal antibody and will be administered intravenously at a dose of 20 mg/kg. The antibody is formulated at 20 mg/mL in 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80.

DRUG

Placebo

Placebo consists of formulation buffer only which is 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80.

Trial Locations (32)

10027

Columbia University, New York

10032

Columbia University, New York

14618

University of Rochester, Rochester

20007

Georgetown University, Washington D.C.

21218

Johns Hopkins University, Baltimore

23298

Virginia Commonwealth University, Richmond

27157

Wake Forest University, Winston-Salem

27705

Duke University Health Center, Durham

30329

Emory University School of Medicine, Atlanta

32611

University of Florida Gainesville, Gainesville

35233

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University, Nashville

40202

University of Louisville, Louisville

43210

Ohio State University, Columbus

43614

University of Toledo, Toledo

45267

University of Cincinnati, Cincinnati

46202

Indiana University School of Medicine, Indianapolis

48105

University of Michigan, Ann Arbor

52242

University of Iowa, Iowa City

63110

Washington University, St Louis

77030

University of Texas Houston Medical School, Houston

80045

University of Colorado - Denver, Aurora

92037

University of California, San Diego, La Jolla

94143

University of California San Francisco, San Francisco

98195

University of Washington and VA Puget Sound Health Care System, Seattle

University of Washington, Seattle

02215

Beth Israel Deaconess Medical Center, Boston

02129

Massachusetts General Hospital, Charlestown

05401

University of Vermont, Burlington

T6G 2R3

University of Alberta, Edmonton

V6T 1Z4

University of British Columbia, Vancouver

H2X 0C1

Centre hospitalier de l'Université de Montréal (CHUM), Montreal

All Listed Sponsors
collaborator

Huntington Study Group

NETWORK

lead

Vaccinex Inc.

INDUSTRY

NCT02481674 - A Study in Subjects With Late Prodromal & Early Manifest HD to Assess the Safety, Tolerability, pk, and Efficacy of Pepi | Biotech Hunter | Biotech Hunter