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AGN-199201 Formulation A

Phase 1

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 Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01579084Safety and Tolerability of AGN-199201 in Patients With Erythema Associated With RosaceaPHASE1 COMPLETED 64Apr 1, 2012Jun 1, 2012Nov 18, 20191 United States
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Study Endpoints
Primary Endpoints
Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1
Baseline, Day 1-hour 6

The percentage of responders was determined by facial sides 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 at Day 1. 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.

Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5
Baseline, Day 5-hour 6

The percentage of responders was determined by facial sides 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 at Day 5. 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 Responders With at Least a 2-Grade Decrease From Baseline on CEA
Baseline, Day 1-hour 6, Day 5-hour 6
Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA
Baseline, Day1-hour 6, Day 5-hour 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AGN-199201 Formulation A and BEXPERIMENTALAGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily.
AGN-199201 Formulation B and CEXPERIMENTALAGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily.
AGN-199201 Formulation C and AEXPERIMENTALAGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily.
AGN-199201 Formulation A and VehicleOTHERAGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation B and VehicleOTHERAGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation C and VehicleOTHERAGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily.
AGN-199201 Formulation AEXPERIMENTALAGN-199201 Formulation A applied to both sides of the face twice daily.
AGN-199201 Formulation BEXPERIMENTALAGN-199201 Formulation B applied to both sides of the face twice daily.
AGN-199201 Formulation CEXPERIMENTALAGN-199201 Formulation C applied to both sides of the face twice daily.
AGN-199201 VehiclePLACEBO_COMPARATORAGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily.
Interventions
NameTypeDescription
AGN-199201 Formulation ADRUGAGN-199201 Formulation A applied to the face as per protocol twice daily.
AGN-199201 Formulation BDRUGAGN-199201 Formulation B applied to the face as per protocol twice daily.
AGN-199201 Formulation CDRUGAGN-199201 Formulation C applied to the face as per protocol twice daily.
AGN-199201 VehicleDRUGAGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * facial erythema associated with rosacea on both sides of the face Exclusion Criteria: * Laser light-source or other energy based therapy in the last 6 months * Excessive hair around the treatment area

Countries:United States
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