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AGN-199201 Dose A

Phase 2

Rosacea | Small molecule | Dermatology |AbbVie Inc.|Last Updated: Nov 18, 2019

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 Enrollment357
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01735201AGN-199201 for the Treatment of Erythema With RosaceaPHASE2 COMPLETED 357Dec 1, 2012Jun 1, 2013Nov 18, 20191 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)
Baseline, Day 28-hours 2 to 12

Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.

Secondary Endpoints
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28
Baseline, Day 28-hour 0.5
Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28
Baseline, Day 28-hour 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AGN-199201 Dose A Once DailyEXPERIMENTALAGN-199201 Dose A applied once daily to the face for 28 days.
AGN-199201 Dose B Once DailyEXPERIMENTALAGN-199201 Dose B applied once daily to the face for 28 days.
AGN-199201 Dose C Once DailyEXPERIMENTALAGN-199201 Dose C applied once daily to the face for 28 days.
AGN-199201 Vehicle Once DailyPLACEBO_COMPARATORAGN-199201 Vehicle applied once daily to the face for 28 days.
AGN-199201 Dose A Twice DailyEXPERIMENTALAGN-199201 Dose A applied twice daily to the face for 28 days.
AGN-199201 Dose B Twice DailyEXPERIMENTALAGN-199201 Dose B applied twice daily to the face for 28 days.
AGN-199201 Dose C Twice DailyEXPERIMENTALAGN-199201 Dose C applied twice daily to the face for 28 days.
AGN-199201 Vehicle Twice DailyPLACEBO_COMPARATORAGN-199201 Vehicle applied twice daily to the face for 28 days.
Interventions
NameTypeDescription
AGN-199201 Dose ADRUGAGN-199201 Dose A applied once or twice daily to the face for 28 days.
AGN-199201 Dose BDRUGAGN-199201 Dose B applied once or twice daily to the face for 28 days.
AGN-199201 Dose CDRUGAGN-199201 Dose C applied once or twice daily to the face for 28 days.
AGN-199201 VehicleDRUGAGN-199201 Vehicle applied once or twice daily to the face for 28 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Redness of the skin caused by rosacea Exclusion Criteria: * ≥3 inflammatory lesions * Laser light-source or other energy based therapy in the last 6 months * Any prescription or over the counter product for the treatment of acne or rosacea in the last 14 days

Countries:United States
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