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AGN-199201 Dose A

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment357

FDA Designations

No designations recorded

Clinical trial landscape

AGN-199201 Dose A · 1 trial · 2 indications

Phase 2 1
NCT01735201AGN-199201 for the Treatment of Erythema With RosaceaRosacea
COMPLETED357 Analytics
PHASE2COMPLETED
AGN-199201 for the Treatment of Erythema With Rosacea
RosaceaUnlock trial analytics

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 to 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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Frequently asked questions about AGN-199201 Dose A

What is AGN-199201 Dose A used for?

AGN-199201 Dose A is an investigational small molecule being studied for the treatment of erythema associated with rosacea, a chronic skin condition. It is in Phase 2 clinical development and is being evaluated in patients with rosacea and erythema.

Who makes AGN-199201 Dose A?

AGN-199201 Dose A is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research on this investigational drug for rosacea.

What phase is AGN-199201 Dose A in?

AGN-199201 Dose A is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial evaluating the drug for erythema with rosacea has been completed.

What clinical trials is AGN-199201 Dose A in?

AGN-199201 Dose A was studied in a completed Phase 2 clinical trial identified as NCT01735201, titled 'AGN-199201 for the Treatment of Erythema With Rosacea.' The trial enrolled 357 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is AGN-199201 Dose A a small molecule?

Yes, AGN-199201 Dose A is a small molecule drug. It is being developed as a dermatology treatment for rosacea, specifically targeting erythema, which is facial redness associated with the condition.