Study of REGN3500 and Dupilumab in Patients With Asthma

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Asthma, Allergic

Treatments: Drug: REGN3500; Drug: Dupilumab; Drug: Placebo; Drug: Fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03112577

R3500-AS-1633

SAR440340 (Other Identifier)

2016-003165-26 (EudraCT Number)

Details and patient eligibility

About

To assess the effects of REGN3500, dupilumab, and REGN3500 plus dupilumab, compared with placebo, on changes in inflammatory gene expression signatures in sputum induced after a bronchial allergen challenge (BAC) in adults with mild allergic asthma, at week 4 after treatment initiation compared with those at screening.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

KEY Inclusion Criteria:

1. Male or female aged between 18 and 60 years
2. Has a Body Mass Index {BMI) of 17 to 33 kg/m2 at pre-study screening
3. Has a history of mild allergic asthma for at least 6 months
4. Is a non-smoker or ex-smoker for at least 12 months

KEY Exclusion Criteria:

1. Has a history of life-threatening asthma
2. Has been hospitalized or has attended the emergency room for asthma in the 12 months prior to screening
3. Has a history of severe allergies or history of an anaphylactic reaction
4. Has a history of drug or alcohol abuse within a year prior to the screening visit

Note: other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

32 participants in 5 patient groups

REGN3500

Experimental group

Description:

REGN3500: masked and randomized dosing regimen per protocol (part 1 only)

Treatment:

Drug: REGN3500

Dupilumab

Experimental group

Description:

Dupilumab: masked and randomized dosing regimen per protocol (part 1 only)

Treatment:

Drug: Dupilumab

REGN3500 plus dupilumab

Experimental group

Description:

REGN3500 plus dupilumab: masked and randomized dosing regimen per protocol (part 1 only)

Treatment:

Drug: REGN3500

Drug: Dupilumab

Placebo

Experimental group

Description:

Placebo: masked and randomized dosing regimen per protocol (part 1 only)

Treatment:

Drug: Placebo

Fluticasone propionate

Active Comparator group

Description:

Fluticasone propionate: open label dosing regimen per protocol (part 2 only)

Treatment:

Drug: Fluticasone propionate