Recent Updates
Recently added Catalysts

REGN1908-1909

Phase 2

Cat Allergy | Small molecule | Immunology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 1, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

REGN1908-1909 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT03838731Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen ChallengeCat Allergy
COMPLETED56 Analytics
PHASE2COMPLETED
Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge
Cat AllergyUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to Early Asthmatic Response (EAR) Upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU) on Day 8
Day 8

Time to EAR was defined as the time to a ≥20% reduction in FEV1 or when the participant voluntarily departed the EEU due to clinically significant allergic and/or asthmatic symptoms.

Change in allergic symptom scale score
At day 8

The primary endpoint is the change in allergic symptom scale score at day 8

Safety
day 1 to day 113

The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study).

Secondary Endpoints

Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85
Days 29, 57 and 85
Percent Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Days 8, 29, 57, and 85
Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Days 8, 29, 57, and 85
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
REGN1908-1909EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Group AEXPERIMENTALParticipants in group A will receive REGN1908-1909
Group BEXPERIMENTALParticipants in group B will receive placebo
Cohort 1EXPERIMENTALDose 1 of REGN1908-1909 or placebo
Cohort 2EXPERIMENTALDose 2 of REGN1908-1909 or placebo
Cohort 3EXPERIMENTALDose 3 of REGN1908-1909 or placebo

Interventions

NameTypeDescription
REGN1908-1909DRUGSingle subcutaneous (SC) dose of REGN1908 and REGN1909
PlaceboDRUGSingle subcutaneous (SC) dose of matching placebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Documented or patient reported history (for at least 2 years) of symptomatic cat allergen-triggered asthma with rhinitis with or without conjunctivitis * No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure o...

Countries:FranceNetherlandsNew ZealandSwedenUnited KingdomUnited States
Unlock Eligibility Criteria

Frequently asked questions about REGN1908-1909

What is REGN1908-1909 used for?

REGN1908-1909 is an investigational therapy being developed for cat allergy and allergy-related conditions. It is being studied in adult participants with allergies, including those with cat allergy and mild asthma. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes REGN1908-1909?

REGN1908-1909 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol REGN. The company is conducting clinical trials to evaluate the safety, tolerability, efficacy, and pharmacokinetics of this investigational drug in allergic adult subjects.

What phase is REGN1908-1909 in?

REGN1908-1909 is in clinical development, with completed Phase 1 and Phase 2 trials. The Phase 1 studies evaluated safety, tolerability, efficacy, and pharmacokinetics in allergic adults, while a Phase 2 study assessed its effect on bronchoconstriction in cat-allergic patients with mild asthma. It remains investigational.

What clinical trials is REGN1908-1909 in?

REGN1908-1909 has been studied in three completed clinical trials. NCT01922661 and NCT02127801 were Phase 1 single ascending-dose studies in allergic adults, and NCT03838731 was a Phase 2 study in cat-allergic patients with mild asthma. All trials enrolled participants aged 18 years and older.

Is REGN1908-1909 the same as other allergy treatments?

REGN1908-1909 is a distinct investigational drug being developed by Regeneron Pharmaceuticals for cat allergy and allergy. It is not described as being the same as any other named medication. Its mechanism of action and specific characteristics are part of ongoing clinical research.