Recent Updates
Recently added Catalysts

AGN-229666

Phase 3

Conjunctivitis, Allergic | Small molecule | Immunology |AbbVie Inc.|Last Updated: Apr 17, 2019

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment380

FDA Designations

No designations recorded

Clinical trial landscape

AGN-229666 · 3 trials · 2 indications

Phase 3 2Phase 2 1
NCT02161146AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic ConjunctivitisConjunctivitis, Allergic
COMPLETED240 Analytics
NCT02082262AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic ConjunctivitisConjunctivitis, Allergic
COMPLETED140 Analytics
PHASE3COMPLETED
AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
Conjunctivitis, AllergicUnlock trial analytics
PHASE3COMPLETED
AGN-229666 Ophthalmic Solution for the Treatment of Seasonal or Perennial Allergic Conjunctivitis
Conjunctivitis, AllergicUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular Itching Score
Days 1 and 15

Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.

Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale
Baseline, Day 70

Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Ocular Itching Score at Day 1
Day 1

The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.

Secondary Endpoints

Conjunctival Hyperemia Score
Days 1 and 15
Ocular Itching Score at Day 15
Day 15
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
AGN-229666EXPERIMENTALOne drop of AGN-229666 in each eye on Days 1 and 15.
VehiclePLACEBO_COMPARATOROne drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
OlopatadineACTIVE_COMPARATOROne drop of olopatadine in each eye on Days 1 and 15.
AGN-229666/OlopatadineOTHEROne drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
AGN-229666/VehicleOTHEROne drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
AGN-229666 Dose AEXPERIMENTALOne drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
AGN-229666 Dose BEXPERIMENTALOne drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
vehicle of AGN-229666PLACEBO_COMPARATOROne drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.

Interventions

NameTypeDescription
AGN-229666DRUGOne drop of AGN-229666 in the eye on Days 1 and 15.
Vehicle to AGN-229666DRUGOne drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
OlopatadineDRUGOne drop of olopatadine in the eye on Days 1 and 15.
vehicle of AGN-229666OTHEROne drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: -Japanese patients living in Japan with a history of allergic conjunctivitis. Exclusion Criteria: * Presence of active eye infection (bacterial, viral, or fungal) * History of an eye herpetic infection.

Countries:Japan
Unlock Eligibility Criteria

Frequently asked questions about AGN-229666

What is AGN-229666 used for?

AGN-229666 is an investigational small molecule being developed by AbbVie Inc. (ABBV) for the treatment of allergic conjunctivitis, including seasonal and perennial allergic conjunctivitis. It is administered as an ophthalmic solution. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does AGN-229666 target?

The specific molecular target of AGN-229666 has not been disclosed in available information. It is a small molecule developed for ophthalmic use in allergic conjunctivitis, but its mechanism of action is not publicly detailed.

Who makes AGN-229666?

AGN-229666 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational ophthalmic solution intended for the treatment of allergic conjunctivitis.

What phase is AGN-229666 in?

AGN-229666 has completed Phase 2 and Phase 3 clinical trials. The Phase 2 trial (NCT01754766) was completed, and two Phase 3 trials (NCT02082262 and NCT02161146) were also completed. The drug is investigational and has not received FDA approval.

What clinical trials is AGN-229666 in?

AGN-229666 has been studied in three completed clinical trials in Japan: NCT01754766 (Phase 2, 90 patients), NCT02082262 (Phase 3, 140 patients), and NCT02161146 (Phase 3, 240 patients). All trials were randomized, double-blind, and placebo-controlled, with no active trials currently ongoing.

Is AGN-229666 the same as any other drug?

No alternative names for AGN-229666 have been reported. The drug is identified solely by its code name AGN-229666 in clinical trial registries and development information.