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IGE-1

Phase 1

Allergic Rhinitis | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Jul 11, 2016

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01723254A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic RhinitisPHASE1 COMPLETED 190Dec 1, 2012Jun 1, 2015Jul 11, 20164 Canada
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Study Endpoints
Primary Endpoints
Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
Within 14 days

Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters \[cm\] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than \[\>\] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: \>10 cm or 21 caliper units and above).

Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
Within 14 days

Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: \>2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to \[\>=\] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
Baseline up to 336 days post study administration or at Early Termination

An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.

Number of Participants With Laboratory Test Abnormalities
Baseline up to 336 days post last study drug administration or Early Termination

Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.

Secondary Endpoints
Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-06444753EXPERIMENTAL -
PF-06444752EXPERIMENTAL -
PlaceboPLACEBO_COMPARATORIntramuscular
Interventions
NameTypeDescription
IGE-1BIOLOGICALIntramuscular, multiple dose
IGE-2BIOLOGICALIntramuscular, multiple dose
SalineBIOLOGICALSaline (0.9% sodium chloride)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Healthy, males or females of non-child bearing potential, who are between 18 and 55 years, inclusive, * Intermittent or persistent allergic rhinitis that is associated with perennial or seasonal allergen reactivity at screening as determined by a positive specific IgE level ≥1...

Countries:Canada
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Competitive Landscape -Allergic Rhinitis 4 trials