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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

VE416 for Treatment of Food Allergy

Clinicaltrials.gov identifier NCT03936998

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted July 23, 2019

Study Description

Brief summary:

This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.

  • Condition or Disease:Peanut Allergy
  • Intervention/Treatment: Combination Product: Vancomycin plus VE416 before PNOIT
    Combination Product: Vancomycin plus VE416 with PNOIT
    Combination Product: Placebo plus VE416 with PNOIT
    Combination Product: Placebo plus placebo with PNOIT
  • Phase: Phase 1/Phase 2
Detailed Description

In this research study the investigators want to learn more about an investigational medicine called VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy. VE416 is a combination of dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines and in combination with peanut flour may help to prevent participants from getting sick (upset stomach, breathing problems, and skin problems) when participants come into contact with peanuts. The investigators are doing this research study to find out if VE416 in combination with vancomycin (an antibiotic) while undergoing peanut oral immunotherapy can help people with peanut allergy. VE416 is a consortium of commensal, or "friendly", dormant (inactive) bacteria given in a capsule. The bacteria are reactivated once they reach participants intestines. The investigators also want to find out if VE416 with peanut oral immunotherapy is safe to take without causing too many side effects.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: This is a single-center, randomized, double-blind trial with four arms evaluating VE416 as pretreatment or concurrent treatment in comparison to low-dose peanut oral immunotherapy (PNOIT) alone.
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: VE416 and Low-dose Peanut Oral Immunotherapy for Treatment of Persistent Peanut Allergy
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: July 2020
  • Estimated Study Completion Date: July 2021
Arms and interventions
Arm Intervention/treatment
Experimental: vancomycin plus VE416 before PNOIT
active vancomycin plus VE416 before PNOIT
Combination Product: Vancomycin plus VE416 before PNOIT
Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT
Experimental: Vancomycin plus VE416 with PNOIT
active vancomycin plus active VE416 with active PNOIT
Combination Product: Vancomycin plus VE416 with PNOIT
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
Experimental: Placebo plus VE416 with PNOIT
placebo vancomycin plus active VE416 with active VE416
Combination Product: Placebo plus VE416 with PNOIT
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
Active Comparator: Placebo plus placebo with PNOIT
placebo vancomycin and placebo VE416 with active peanut oral immunotherapy
Combination Product: Placebo plus placebo with PNOIT
Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by placebo for VE416 PO QD x 6 weeks with concomitant PNOIT
Outcome Measures
  • Primary Outcome Measures: 1. Primary Endpoint- Phase 1b [ Time Frame: 7 weeks ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  • 2. Primary Endpoint- Phase II [ Time Frame: 23 weeks, with 24 week Post-Phase II maintenance phase followed by a DBPCFC ]
    The geometric mean of the maximum tolerated dose (MTD) of peanut protein at DBPCFC1
  • Secondary Outcome Measures: 1. Secondary Endpoint- Efficacy [ Time Frame: 54 weeks ]
    The percentage of patients tolerating 600 mg (1030 mg cumulative) at DBPCFC1 without treatment
  • 2. Secondary Endpoint- Safety [ Time Frame: 54 weeks ]
    The occurrence of treatment related adverse events
Eligibility Criteria
  • Ages Eligible for Study: 12 to 55 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- People of all ethnic/racial/gender groups aged 12-55 years old with a documented
medical history of peanut allergy.

- Evidence of peanut-specific IgE by either: positive skin prick test to peanut
(reaction wheal at least 5 mm larger than saline control) or serum peanut-specific IgE
_5 kU/L at screening visit.

- Ara h 2 specific IgE >0.35 kU/L at screening visit.

- Willing to sign informed consent or whose parent or legal guardian is willing to sign
the consent form (age appropriate).

- Willing to sign the assent form, if age appropriate.

- (For continuation into Phase II only) Allergic reaction requiring treatment at _ 100
mg dose of peanut protein during Entry Challenge.

Exclusion Criteria:

- History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 30% below predicted normal
for sex, height, weight or from known baseline), neurological compromise (confusion,
loss of consciousness), or incontinence.

- Severe or Moderate asthma as defined using the severity criteria of the current NHLBI
Guidelines for the Diagnosis and Management of Asthma
(http://www.nhlbi.nih.gov/guidelines/asthma/).

- Poorly-controlled asthma as defined by FEV1 2 days/week or rescue medication use >2 days / week.

- Diagnosis of other severe or complicating medical problems, including autoimmune or
chronic immune inflammatory conditions or gastrointestinal inflammatory conditions,
including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal
Disorders

- Inability to cooperate with and/or perform oral food challenge procedures.

- Inability to swallow size 0 capsule

- Primary Immune Deficiency

- Allergy to oat confirmed by skin prick testing and history

- Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine
oxidase inhibitors

- Women of childbearing potential who are pregnant, planning to become pregnant, or
breastfeeding

- Hematocrit <0.36 for adult females or <0.38 for adult males Weight <23 kg - Use within the past 6 months of other systemic immunomodulatory treatments including allergen immunotherapy, or use of biologics with an immune target, including omalizumab. - Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.

Contacts and Locations
Contacts

Contact: Wayne G Shreffler, MD, PhD 617-726-6147 wshreffler@mgh.harvard.edu

Contact: Cynthia A Esteban, NP, MPH 617-724-2081 cesteban@mgh.harvard.edu

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston

Sponsors and Collaborators

Massachusetts General Hospital

Vedanta Biosciences, Inc.

Investigators

Principal Investigator: Wayne G Shreffler, MD, PhD Massachusetts General Hospital

More Information
  • Responsible Party: Massachusetts General Hospital
  • ClinicalTrials.gov Identifier: NCT03936998 History of Changes
  • Other Study ID Numbers: 2019P000886
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: July 23, 2019
  • Last Verified: July 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Hypersensitivity Peanut Hypersensitivity