Omalizumab Weight-Based Dosing Efficacy Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06943534
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Allergies
  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
1 Year - 55 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.

Key Dates

Start date
Jul 3, 2025
Status verified
Feb 2026
Primary completion
May 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Patients Receiving 5mg/kg of omalizumab
    Participants randomized to this arm will receive a does of 5mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.
  • Active Comparator: Patients Receiving 15mg/kg of omalizumab
    Participants randomized to this arm will receive a does of 15mg/kg Omalizumab per month divided every two (2) weeks for 16 weeks.

Primary Outcome Measure

Proportion of participants that tolerate the 600 mg dose after treatment. [ Time Frame: 16 Weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Jannat Gill
[email protected]
614-643-8683
Wayne Shreffler, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Lauren Herlihy
[email protected]
University of Texas SouthwesternDallasTexas75390
Dolores Santoyo
[email protected]

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By research site
Massachusetts General Hospital· Boston, MAUniversity of North Carolina at Chapel Hill· Chapel Hill, NCUniversity of Texas Southwestern· Dallas, TX

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