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A Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut.

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ClinicalTrials.gov Identifier: NCT04603300
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Intrommune Therapeutics

Tracking Information
First Submitted Date  ICMJE September 25, 2020
First Posted Date  ICMJE October 26, 2020
Last Update Posted Date March 17, 2021
Estimated Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study. [ Time Frame: Eight weeks ]
Percentage of participants able to consistently tolerate the protocol-specified highest dose; Incidence of systemic and non-systemic adverse reactions.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2021)
To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301. [ Time Frame: Eight weeks ]
Number of participants requiring treatment for systemic reactions related to experimental treatment or placebo; Number of adverse events requiring treatment for systemic reactions related to experimental treatment or placebo; Adherence to study treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
  • To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301. [ Time Frame: Eight weeks ]
    Number of participants requiring treatment for systemic reactions related to experimental treatment or placebo; Number of adverse events requiring treatment for systemic reactions related to experimental treatment or placebo; Adherence to study treatment.
  • To evaluate the effect of power toothbrush use on adverse events and compliance. [ Time Frame: Eight weeks ]
    Number of participants experiencing adverse events while using power toothbrushes; Percentage of doses taken in compliance with protocol instructions as demonstrated by smart power toothbrush data.
Current Other Pre-specified Outcome Measures
 (submitted: October 23, 2020)
To explore changes in peanut-specific IgG4 and IgE levels in participants (exploratory outcome). [ Time Frame: Eight weeks ]
Change from baseline of peanut-specific IgG4 and IgE in study subjects (exploratory outcome)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut.
Official Title  ICMJE A Randomized Placebo-Controlled Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut.
Brief Summary This is a phase 1, single-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The treatment group will be blinded to the investigator, participants, and the Intrommune study team.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double blind is controlled by IWRS
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE
  • Drug: INT301
    INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste
  • Drug: Placebo
    Fully functional toothpaste containing no immunotherapy agents
Study Arms  ICMJE
  • Active Comparator: Active treatment
    INT301 dosing as determined by cohort assignment
    Intervention: Drug: INT301
  • Placebo Comparator: Placebo
    Placebo as determined by cohort assignment
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2020)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participant must be 18-55 years of age inclusive, at the time of signing the informed consent.

Female participants of childbearing potential or male participants with female partners of child-bearing potential must utilize highly effective birth control method(s) throughout the study and for 30 days after the final dose of study drug. Acceptable methods of contraception include: complete abstinence, male or female condoms with spermicide, oral or implanted contraceptives, or vasectomy.

For female participants of child-bearing potential: Negative serum beta human chorionic gonadotrophin (HCG) pregnancy test at screening.

Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Meets at least one of the following conditions

  • Positive skin prick test (SPT) (wheal at least 3 mm greater than control) AND/OR Peanut specific IgE >.35 kU/L
  • Convincing clinical history of allergic reaction to peanut within 1 hour of ingestion for at least 3 months prior to screening.
  • Failed an oral food challenge (OFC) of < 100mg of peanut protein at screening.
  • Participant willing and able to undergo the procedures required by the protocol, including, assessment completion, protocol compliance, and participation in the placebo dosing period(s).

Exclusion Criteria:

  • History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations < 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
  • Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions
  • Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
  • Psychiatric disorders that the Investigator believes will interfere with study assessments
  • Uncontrolled asthma, defined by at least one of the following conditions:

    • - FEV1 <80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) <75% of predicted, with or without controller medications.
    • - Inhaled corticosteroids (ICS) dosing of >500mcg daily fluticasone (or equivalent ICS based on NHLBI dosing chart.
    • - One hospitalization in the past year for asthma
    • - An ER visit for asthma within six months prior to screening
  • Planned dental surgery during from screening until study exit
  • Moderate or advanced periodontal disease.
  • Current pregnancy or lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Erick B Berglund, PhD 646.895.0741 eberglund@intrommune.com
Contact: Michael Nelson, JD mnelson@intrommune.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04603300
Other Study ID Numbers  ICMJE INT301-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intrommune Therapeutics
Study Sponsor  ICMJE Intrommune Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Intrommune Therapeutics
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP