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A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)

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ClinicalTrials.gov Identifier: NCT03644069
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
ImmusanT, Inc.

Brief Summary:
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).

Condition or disease Intervention/treatment Phase
Celiac Disease Celiac Intestinal Disease Malabsorption Syndromes Gastrointestinal Disease Digestive System Disease Gluten Sensitivity Autoimmune Diseases Biological: Nexvax2 Biological: Placebo Phase 2

Detailed Description:
A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adults subjects with confirmed CeD who have been following a gluten free diet for at least 12 consecutive months prior to screening. This study will evaluate efficacy of Nexvax2 administered subcutaneously. The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4 week post-treatment observational follow-up.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study in HLA-DQ2.5+ Adults With Celiac Disease to Assess the Effect of Nexvax2 on Symptoms After Masked Gluten Food Challenge
Actual Study Start Date : August 6, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arm Intervention/treatment
Experimental: Nexvax2 Biological: Nexvax2
Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals

Placebo Comparator: Placebo Biological: Placebo
Placebo SQ injections: 32 in total, at twice weekly intervals




Primary Outcome Measures :
  1. Efficacy of Nexvax2 compared to placebo in reducing Celiac Disease (CeD) associated GI symptoms. [ Time Frame: 79 to 93 days after baseline ]
    Measured by the CeD Patient Reported Outcome (CeD PRO) between baseline and day of the first masked food challenge (MFC) containing gluten. The CeD PRO captures patient ratings for a number of CeD-associated symptoms, on a 0 to 10 scale, with 0 being absent or no symptoms, and 10 being the most severe symptoms. The Total GI domain score is calculated as an average of summed average and individual symptom scores relevant to the GI tract, to yield a value of 0 to 10.


Secondary Outcome Measures :
  1. Evaluate efficacy of Nexvax 2 compared with placebo on immune-system activation after the first MFC containing gluten. [ Time Frame: 79 to 93 days after baseline ]
    Differences in levels of pharmacodynamic markers between baseline and day of the first MFC containing gluten.

  2. Evaluate efficacy of Nexvax2 compared with placebo in reducing CeD associated GI symptom sub-domains. [ Time Frame: 79 to 93 days after baseline ]
    Differences in daily GI symptom domain score between baseline and day of the first MFC containing gluten.

  3. Evaluate efficacy of Nexvax2 compared with placebo in reducing individual GI symptoms. [ Time Frame: 79 to 93 days after baseline ]
    Differences in each of the individual GI item scores in the CeD PRO between baseline and day of the first MFC containing gluten. GI symptoms assessed on the CeD PRO include abdominal cramping, abdominal pain, bloating, diarrhea, gas, loose stool, and nausea. Each are rated on a 0 to 10 scale, where 0 is absent and 10 is the most severe.

  4. Incidence of Treatment-Emergent Adverse Events (TEAEs) in assessing safety and tolerability of Nexvax2. [ Time Frame: Study Duration: 21 weeks ]
    Treatment emergent adverse events (TEAEs) will be summarized by treatment arm, severity, relationship to study drug and to known or potential gluten exposure, and phase of treatment and presented as the number and percentage of patients reporting an event(s) as well as the number of events reported.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18 to 70 years of age (inclusive)
  • History of medically diagnosed celiac disease (CeD) that included duodenal biopsy
  • Maintenance of gluten free diet (GFD) for at least 12 consecutive months prior to screening.
  • Willingness to consume a moderate amount of gluten
  • Able to read and understand English
  • Worsening of GI symptoms in response to an oral gluten challenge
  • HLA DQ 2.5 positive

Exclusion Criteria:

  • Unwilling or unable to perform self-injections
  • History of inflammatory bowel disease and/or microscopic colitis.
  • Any medical condition or lab abnormality that in the opinion of the investigator may interfere with study conduct or would impact the immune response (other than CeD), confound interpretation of study results, or pose an increased risk to the subject.
  • Use of immunomodulatory or immune-suppressing medical treatment during the 6 months prior to screening
  • Use of oral or parenteral immunomodulatory corticosteroids, within the 6 weeks prior to screening. Topical or inhaled corticosteroids are acceptable.
  • Receipt of any investigational drug or participation in another clinical study within 6 months prior to screening.
  • Females who are lactating or pregnant
  • Receipt of any vaccine within 1 week prior to planned first day of the treatment period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644069


Contacts
Contact: Kristin Neff 1-617-299-8399 immusantclinops@immusant.com
Contact: Holly Hand immusantclinops@immusant.com

  Hide Study Locations
Locations
United States, California
Diablo Clinical Research Recruiting
Walnut Creek, California, United States, 94598
Contact: Lana Norman    925-930-7267    lnorman@diabloclinical.com   
Principal Investigator: Helen Stacey         
United States, Connecticut
Stamford Therapeutics Consortium Recruiting
Stamford, Connecticut, United States, 06905
Contact: Jeff Stein    203-325-8529    jstein@stctrials.com   
Principal Investigator: David Radin         
United States, Florida
Alliance Medical Research Recruiting
Lighthouse Point, Florida, United States, 33064
Contact: Lizane Norelia    954-667-4226    lizanenorelia@pioneerclinical.com   
Principal Investigator: Vipin Gupta         
United States, Idaho
Grand Teton Research Group Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Ana Goetsch    208-528-4256    ana@gtrgi.org   
Principal Investigator: Clint Behrend         
United States, Illinois
UCMC - Center for Clinical Cancer Genetics and Global Health Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Iowa
PMG Research of McFarland Clinic Recruiting
Ames, Iowa, United States, 50010
Contact: Erin Hackett    515-956-4159    erin.hackett@pmg-research.com   
Principal Investigator: Bryan Feyen         
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Debi Heitshusen    319-353-4576    debi-heitshusen@uiowa.edu   
Principal Investigator: David Elliott         
United States, Kansas
Heartland Research Associates Recruiting
Wichita, Kansas, United States, 67207
Contact: Jill Hiebert    316-689-6683    jhiebert@heartlandresearch.com   
Principal Investigator: Thomas Klein         
United States, Michigan
Clinical Research Institute of Michigan Recruiting
Chesterfield, Michigan, United States, 48047
Contact: Brittany McKenzie    586-598-3329    bmckenzie@researchmi.com   
Principal Investigator: Ronald Fogel         
Center for Digestive Health Recruiting
Troy, Michigan, United States, 48098
Contact: Sandra McMillan    248-267-8485 ext 8916    smcmillan@troygastro.com   
Contact: Heather LaHaise    248-267-8485 ext 6606    hlahaise@troygastro.com   
Principal Investigator: John Weber         
West Michigan Clinical Research Center Recruiting
Wyoming, Michigan, United States, 49519
Contact: Rochelle Copeland    616-608-8730    rcopeland@gastro-assoc-wm.com   
Contact: Ashley Ginder    616-328-5319    aginder@gastro-assoc-wm.com   
Principal Investigator: Allan Coates         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, Nevada
AB Clinical Trials Recruiting
Las Vegas, Nevada, United States, 89119
Contact: Atoya Adams, MD    702-804-5900    dradams27@msn.com   
Principal Investigator: Atoya Adams         
United States, New Hampshire
ActivMed Practices & Research Recruiting
Portsmouth, New Hampshire, United States, 03801
Contact: Kendra Thibeault    603-319-8863    kthibeault@activmedresearch.com   
Principal Investigator: Roger Epstein         
United States, New York
Long Island Gastrointestinal Research Group Recruiting
Great Neck, New York, United States, 11023
Contact: Christine Raiser    516-482-5976    christineraiser@ligiresearch.com   
Principal Investigator: Michael Goldstein         
Drug Trials America Recruiting
Hartsdale, New York, United States, 10530
Contact: Jeremy Tark    914-341-2346    jtark@drugtrialsamerica.com   
Principal Investigator: Michael Gerdis         
Celiac Disease Center at Columbia University Not yet recruiting
New York, New York, United States, 10032
United States, North Carolina
PMG Research of Piedmont Healthcare Recruiting
Statesville, North Carolina, United States, 28625
Contact: Erin Hutchens    704-924-2105    erin.hutchens@pmg-research.com   
Principal Investigator: Vivek Trivedi         
PMG Research of Winston-Salem, LLC Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Ashley Schmidt    336-768-8062    ashley.schmidt@pmg-research.com   
Principal Investigator: Robert Holmes         
United States, Ohio
Great Lakes Gastroenterology Research Recruiting
Mentor, Ohio, United States, 44060
Contact: Debbie Donohue    440-205-1225 ext 216    ddonohue@glmrx.com   
Principal Investigator: Keith Friedenberg         
United States, Pennsylvania
Thomas Jefferson University Hospitals - Center City Campus Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Patrick Casey    215-503-4683    patrick.casey@jefferson.edu   
Principal Investigator: Anthony DiMarino         
United States, Rhode Island
Ocean State Clinical Research Partners Recruiting
Lincoln, Rhode Island, United States, 02865
Contact: David McPhail    401-475-7007    dmcphailoscr@gmail.com   
Contact: Pete LaTorre    401-475-7007    platorreoscr@gmail.com   
Principal Investigator: Scott Wilson         
Omega Medical Research Recruiting
Warwick, Rhode Island, United States, 02886
Contact: Monica Freeman    401-739-9350 ext 261    monica@omegamedicalresearch.com   
Principal Investigator: Eric Newton         
United States, South Carolina
Coastal Carolina Research Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Danielle Nelson    843-856-3784    dnelson@coastalcarolinaresearch.com   
Principal Investigator: Cynthia Strout         
United States, Tennessee
Digestive Health Research Recruiting
Hermitage, Tennessee, United States, 37076
Contact: Nicole Jordan    615-499-4740    njordan@digestivehealthresearch.com   
Principal Investigator: George James         
United States, Texas
Texas Digestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
Contact: Caela Watkins    817-424-1525    cwatkins@tddctx.com   
Principal Investigator: Timothy Ritter         
United States, Utah
Advanced Research Institute Recruiting
South Ogden, Utah, United States, 84405
Contact: Nephi Georgi    801-409-2040    nephi@advresearch.org   
Principal Investigator: John Lowe         
United States, Wisconsin
Allegiance Research Specialists Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Melissa Voigt    414-727-8131    voigt@arsmke.com   
Principal Investigator: Samuel Idarraga         
Australia, Queensland
The Wesley Hospital - The Wesley Research Institute Not yet recruiting
Auchenflower, Queensland, Australia, 4066
Contact: Venita Bali    (07) 3721 1543    vbali@wesleyresearch.com.au   
Contact: Lauren Old    (07) 3721 1548    lold@wesleyresearch.com.au   
Principal Investigator: James Daveson         
Coral Sea Clinical Research Institute Not yet recruiting
Mackay, Queensland, Australia, 4740
Contact: Amanda Flanagan    07 4942 3777    aflanaga@usc.edu.au   
Principal Investigator: James Daveson         
Clinical Trials Centre - University of the Sunshine Coast Not yet recruiting
Sippy Downs, Queensland, Australia, 4556
Contact       trials@usc.edu.au   
Principal Investigator: Susan Thackwray         
The University of Queensland - Princess Alexandra Hospital Not yet recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Teressa Hansen    61418777202    Teressa.Hansen@health.qld.gov.au   
Principal Investigator: Gerald Holtmann         
Australia, Southern Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, Southern Australia, Australia, 5000
Contact: Lorelle Smith    08 7074 2201    Lorelle.smith@sa.gov.au   
Contact: Julie McMahon    08 7074 2200    Julie.mcmahon@sa.gov.au   
Principal Investigator: Jane Andrews         
Australia, Victoria
Eastern Health-Box Hill Hospital Not yet recruiting
Box Hill, Victoria, Australia, 3128
Contact: Emma Dimitri    +61 3 9094 9531    Emma.dimitri@monash.edu   
Principal Investigator: SweeLin Chen Yi Mei         
Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Paula Lewis    +61 3 90765276    Paula.Lewis@alfred.org.au   
Contact: Robyn Secomb    +61 3 90765737    R.Secomb@alfred.org.au   
Principal Investigator: Gregor Brown         
The Royal Melbourne Hospital - The Walter and Eliza Hall Institute of Medical Research Recruiting
Parkville, Victoria, Australia, 3052
Contact: Cathy Pizzey    61 3 9345 2300    coeliac@wehi.edu.au   
Principal Investigator: Jason Tye-Din         
Australia, Western Australia
Sir Charles Gairdner Hospital Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Jennifer Hu    +61 8 6382 5123    jhu@linear.org.au   
Principal Investigator: Hooi Ee         
New Zealand
Auckland Clinical Studies Recruiting
Auckland, New Zealand, 1010
Contact: Margaret Joppa    64 9 373 3474 ext 105    biscuit@clinicalstudies.co.nz   
Principal Investigator: Timothy King         
Gastroenterology and Endoscopy Specialists Not yet recruiting
Christchurch, New Zealand, 8011
P3 Research Limited Recruiting
Mount Cook, New Zealand, 6021
Contact: Mary McKay    64 4 801 0002    mary@p3research.co.nz   
Principal Investigator: Dean Quinn         
Sponsors and Collaborators
ImmusanT, Inc.
Investigators
Study Chair: Robert Anderson, PhD, FRACP ImmusanT, Inc.

Additional Information:
Responsible Party: ImmusanT, Inc.
ClinicalTrials.gov Identifier: NCT03644069     History of Changes
Other Study ID Numbers: Nexvax2-2006
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Celiac Disease
Autoimmune Diseases
Gastrointestinal Diseases
Digestive System Diseases
Malabsorption Syndromes
Intestinal Diseases
Metabolic Diseases
Immune System Diseases