SIGNAL

SIGNAL: A new investigational approach to early treatment of Huntington’s disease

Vaccinex and the Huntington Study Group (HSG) launched a new trial for people with the gene mutation that causes HD who are either early in the progression of the disease or are not yet diagnosed with the disease.

The SIGNAL trial is designed to assess the safety, tolerability, and effectiveness of VX15, a novel monoclonal antibody in people with late prodromal or early manifest Huntington’s disease (HD). It is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study at 20 sites across the United States that seeks to enroll approximately 116 individuals, 21 or older, who are either early in the progression of the disease or are not yet diagnosed with the disease.

The investigational compound that will be studied in the trial is VX15, a monoclonal antibody. This is a different class of drug than any other drug used in previous HD clinical trials. Monoclonal antibodies are more specific than most other drugs because they only bind to and neutralize their desired target. Previous research suggests that VX15 may have the potential to slow the progression of brain inflammation, which has been shown to impair thinking, movement, and behavior in HD animal models.

VX15 has not been approved by the FDA; its potential benefits for HD are being investigated within the SIGNAL trial.

The VX15 antibody is designed to respond specifically to the semaphorin 4D (SEMA4D) protein, a molecule that guides the activation and movement of cells within the body. In HD, VX15 has the potential to block SEMA4D, which may be responsible for inflammation in the brains of individuals who develop HD. Reducing brain inflammation may slow HD’s subsequent effects, including impaired cognition, movement, and behavior.

The study procedures involves:

  • A screening visit to confirm eligibility. Approved subjects will complete a baseline visit and then begin the investigational period
  • Once a month drug or placebo delivery through an approximately hour-long intravenous infusion
  • Brain imaging and cognitive testing during specified visits – these monthly visits may take a full day to complete
  • Lumbar puncture for collection of cerebrospinal fluid for subjects in Cohort B who volunteer
  • Safety, tolerability, and efficacy assessments will be performed at all visits
  • Subjects will be treated with drug or placebo intravenous infusion for 12-18 months
    • Cohort A will receive drug or placebo for six months and then for the next six months, all participants will receive drug. (Enrollment in Cohort A is now complete. To view the press release from Vaccinex, click here. To view press release from Vaccinex about preliminary imaging data from Cohort A, click here.) 
    • Cohort B will receive drug or placebo for 18 months.
  • A follow-up period includes a follow-up safety phone call at one month and a follow-up safety visit at three months after the final infusion.

SIGNAL participants may enroll in observational studies, but they cannot participate in other clinical trials of investigational compounds. Participants may still be eligible for SIGNAL if they are taking other prescribed medications.

To participate, you must visit your chosen site on a monthly basis during the trial period.

Participating sites and contact information:

Columbia University Medical Center

New York, NY

Paula Wasserman, coordinator

 pl2032@cumc.columbia.edu

 (212) 305-4597

 

Duke University

Durham, NC

Peggy Perry-Trice, coordinator

 peggy.perrytrice@duke.edu

 (919) 684-0865

 

Emory University School of Medicine

Atlanta, GA

Elaine Sperin, coordinator

 esperin@emory.edu

 (404) 712-7044

 

Georgetown University

Washington, DC

Hope Heller, coordinator

 hope.heller@medstar.net

 (202) 687-1366

 

Massachusetts General Hospital

Boston, MA

Keith Malarick, coordinator

 kmalarick@partners.org

 (617) 726-5892

 

Ohio State University

Columbus, OH

Allison Daley, coordinator

 allison.daley@osumc.edu

 (614) 688-8672

 

University of Alabama at Birmingham

Birmingham, AL

Jenna Smith, coordinator

 jennat@uab.edu

 (205) 996-2807

 

University of California, San Diego

San Diego, CA

Sungmee Park, coordinator

Sup035@ucsd.edu

(858) 249-0568

 

University of Cincinnati

Cincinnati, OH

Hilary Perez, coordinator

 hilary.perez@uc.edu

 (513) 558-0112

 

University of Colorado

Aurora, CO

Mary Cook, coordinator

 mary.m.cook@ucdenver.edu

 (303) 724-7968

 

University of Iowa

Iowa City, IA

Terry Hayes, coordinator

 terry-hayes@uiowa.edu

 (319) 353-4438

 

University of Louisville

Louisville, KY

Annette Robinson, coordinator

 annette.robinson@louisville.edu

 (502) 540-3585

 

University of Michigan

Ann Arbor, MI

Elizabeth Sullivan, coordinator

 elizsull@med.umich.edu

 (734) 232-6247

 

University of Rochester

Rochester, NY

Amy Chesire, coordinator

 amy_chesire@urmc.rochester.edu

 (585) 341-7519

 

University of Toledo

Toledo, OH

Julia Spears, coordinator

 julia.spears@utoledo.edu

 (419) 383-6728

 

University of Vermont

Burlington, VT

Emily Houston, coordinator

 emily.houston@uvm.edu

 (802) 656-8989

 

Vanderbilt University

Nashville, TN

Philip Siragusa, coordinator

philip.w.siragusa@Vanderbilt.edu

(615) 875-1182

 

Wake Forest University

Winston Salem, NC

Christine O’Neill, coordinator

 coneill@wakehealth.edu

 (336) 716-8611

 

Washington University

St. Louis, MO

Melissa Ammel, coordinator

 ammelm@neuro.wustl.edu

 (314) 747-3470

 

 

 

Enrollment in Cohort A is now complete. To view the press release from Vaccinex, click here. To view a press release from Vaccinex about preliminary imaging data from Cohort A, click here.

If you or someone close to you is interested in taking part in SIGNAL, or if you would like additional information or have questions regarding the study, please contact a site near you or the Huntington Study Group at 1-800-487-7671 or info@hsglimited.org.

To view the brochure about the trial, click here: Signal Flyer
help4hdFeiginhelp4hd

Listen to Dr. Andy Feigin, principal investigator, talk about the SIGNAL trial on Help4HD’s radio blog on the Aug. 14, 2015, episode.