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Omalizumab

Phase 2

Hypersensitivity | Small molecule | Other |Harvard Bioscience, Inc.|Last Updated: May 21, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment108
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03679676Clinical Study Using Biologics to Improve Multi OIT Outcomes (COMBINE)PHASE2 COMPLETED 108 — — Feb 5, 2020May 2, 2025May 21, 20253 United States
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Study Endpoints
Primary Endpoints
The success rates of passing a peanut Double-Blind Placebo Controlled Food Challenge (DBPCFC)
44 weeks

Success is defined as passing a cumulative dose of \>=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B.

The success rates of passing a DBPCFC to peanut and at least one other FA
44 weeks

Success is defined as passing a cumulative dose of \>=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B.

The success rates of passing a DBPCFC to peanut and two other FAs
44 weeks

Success is defined as passing a cumulative dose of \>=1,043 mg at the Week 44 DBPCFC if the subject has no or mild objective reactions. The primary endpoints would be compared between cohort A and cohort B.

Secondary Endpoints
Proportion of participants who successfully pass DBPCFCs to a cumulative dose of >=1,043 mg protein to 1, 2, or 3 FAs when applicable at week 44
44 weeks
Proportion of participants who successfully pass DBPCFCs to a cumulative dose of ≥2,043 mg to 1, 2, or 3 FAs when applicable at week 32
32 weeks
Proportion of participants who pass DBPCFCs for each FA at a cumulative dose of ≥1,043 mg, ≥2,043 mg, or ≥4,043 mg at week 32 and/or week 44.
week 32 and/or 44
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A: OmalizumabOTHERParticipants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with placebo
Cohort B: Omalizumab/DupilumabOTHERParticipants will be treated with omalizumab for 8 weeks, followed by 24 weeks of treatment with dupilumab.
Cohort C: DupilumabOTHERParticipants will be treated with placebo for 8 weeks, followed by 24 weeks of treatment with dupilumab.
Interventions
NameTypeDescription
OmalizumabDRUGOmalizumab is injected every 2 to 4 weeks
DupilumabDRUGDupilumab is injected every 2 weeks combination, or placebo.
PlaceboOTHERPlacebo is injected every 2 to 4 weeks
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Eligibility Criteria
Age Range4 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Age 4 through 55 years (inclusive). * Clinical history of peanut allergy and 1 or 2 additional foods from the following foods: milk, almond, shellfish, fish, cashew, hazelnut, egg, walnut, sesame seeds, soy, and wheat. Allergy to milk and egg is defined as unable to tolerate b...

Countries:United States
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