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NS2

Phase 2

Allergic Conjunctivitis | Small molecule | Ophthalmology |Aldeyra Therapeutics, Inc.|Trials Updated: Dec 5, 2023

NS2 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Apr 2015

NS2 target and mechanism

ModalitySmall molecule

Also known as Active topical NS2 1% dermatologic cream, Active NS2 1% dermatologic, NS2 Ophthalmic Drops (0.5%)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLED
Total Trials3
Total Enrollment157

FDA Designations

No designations recorded

NS2 clinical trials

NS2 · 3 trials · 4 indications

Phase 2 3
NCT02578914A Safety and Activity Study of NS2 in Subjects With Allergic ConjunctivitisAllergic Conjunctivitis
COMPLETED100 Analytics
NCT02402309A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)Sjögren-Larsson Syndrome
COMPLETED12 Analytics
NCT02406209A Safety and Efficacy Study of NS2 in Patients With Anterior UveitisNon-infectious Anterior Uveitis
COMPLETED45 Analytics
PHASE2COMPLETED
A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis
Allergic ConjunctivitisUnlock trial analytics
PHASE2COMPLETED
A Study of Topical NS2 Cream to Treat Ichthyosis in Sjögren-Larsson Syndrome (SLS)
Sjögren-Larsson SyndromeUnlock trial analytics
PHASE2COMPLETED
A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis
Non-infectious Anterior UveitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular Itching Score at Day 14, 60 Minutes Into the Allergen Challenge
The efficacy assessment period was assessed at Day 14; baseline was Day -7.

Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = none, 4 = severe) on Day 14, 60 minutes into the allergen challenge. The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.

Number of Participants Experiencing a Serious Adverse Event (SAE).
The safety assessment period is approximately 9 weeks.
Number of Participants Experiencing an Adverse Event Leading to Discontinuation.
The safety assessment period is approximately 9 weeks.
Anterior Chamber Cell Grade at Week 8
The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NS2 Ophthalmic Drops (0.5%)EXPERIMENTALNS2 Ophthalmic Drops (0.5%)
NS2 Ophthalmic Drops Vehicle (0.0%)SHAM_COMPARATORNS2 Ophthalmic Drops Vehicle (0.0%) control
Active topical NS2 1% dermatologic creamEXPERIMENTALNS2 1% topical cream for dermal application
Topical vehicle dermatologicPLACEBO_COMPARATORVehicle placebo for dermal application
NS2EXPERIMENTALNS2 ophthalmic drops (0.5%) in the affected eye
NS2 and Pred ForteEXPERIMENTALNS2 ophthalmic drops (0.5%) and Prednisolone acetate ophthalmic suspension (1%) in the affected eye
Pred ForteACTIVE_COMPARATORPrednisolone acetate ophthalmic suspension (1%) in the affected eye

Interventions

NameTypeDescription
NS2 Ophthalmic Drops (0.5%)DRUG -
NS2 Ophthalmic Drops Vehicle (0.0%)DRUG -
Active topical NS2 1% dermatologic creamDRUG -
Vehicle placebo 0.0% NS2 dermatologic creamDRUG -
NS2DRUGNS2 ophthalmic drops (0.5%)
Prednisolone acetate ophthalmic suspension (1%)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of \>2 * Graded ocular itching at any one time point * Visual acuity of at least 20...

Countries:CanadaUnited States
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Frequently asked questions about NS2

What is NS2?

NS2 is an investigational small molecule developed by Aldeyra Therapeutics, Inc. (ticker ALDX) for ophthalmic and dermatologic conditions. It is being studied in allergic conjunctivitis, non-infectious anterior uveitis, and Sjögren-Larsson syndrome. NS2 is in Phase 2 clinical development and has not been approved by the FDA.

What is NS2 used for?

NS2 is being developed for allergic conjunctivitis, non-infectious anterior uveitis, and Sjögren-Larsson syndrome. These are the three indications studied in its completed Phase 2 trials. NS2 is investigational and is not approved for any use.

Who makes NS2?

NS2 is developed by Aldeyra Therapeutics, Inc., which trades on the Nasdaq under the ticker ALDX. The company is the sponsor of the clinical trials evaluating NS2 in allergic conjunctivitis, non-infectious anterior uveitis, and Sjögren-Larsson syndrome.

What phase is NS2 in?

NS2 is in Phase 2 clinical development. All three of its completed trials were Phase 2 studies. NS2 is investigational and has not been approved by the FDA for any indication.

What clinical trials is NS2 in?

NS2 has been studied in three completed Phase 2 trials: NCT02578914 in allergic conjunctivitis, NCT02406209 in non-infectious anterior uveitis, and NCT02402309 in Sjögren-Larsson syndrome. All three trials are completed, and no active trials are currently listed.

Is NS2 the same as Active topical NS2 1% dermatologic cream or NS2 Ophthalmic Drops (0.5%)?

Yes, NS2 is also known as Active topical NS2 1% dermatologic cream, Active NS2 1% dermatologic, and NS2 Ophthalmic Drops (0.5%). These names refer to the same investigational small molecule developed by Aldeyra Therapeutics for ophthalmic and dermatologic indications.