Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis

NCT04709575 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: R5713-5714-5715-ALG-20012020-004094-52
• Study Type: interventional
• Target: 353
• Locations: 5 countries
• Sites: 37

Brief Summary

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.

Conditions

Allergic Rhinitis; Conjunctivitis

Keywords

Birch Allergy

Outcome Measures

Primary Outcomes (1)

• Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

  The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).

  Until the end of Birch Pollen Season, up to Week 16

Secondary Outcomes (15)

• Total Symptom Score (TSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

  Until the end of Birch Pollen Season, up to Week 16

• Total Nasal Symptom Score (TNSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

  Until the end of Birch Pollen Season, up to Week 16

• Total Ocular Symptom Score (TOSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

  Until the end of Birch Pollen Season, up to Week 16

• Daily Medication Score (DMS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo

  Until the end of Birch Pollen Season, up to Week 16

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study

  Up to Day 127

Study Arms (2)

REGN5713-5714-5715

EXPERIMENTAL

REGN5713-5714-5715 administered subcutaneously

Drug: REGN5713; Drug: REGN5714; Drug: REGN5715

Placebo Only

PLACEBO COMPARATOR

Placebo matching REGN5713-5714-5715 administered subcutaneously

Drug: Placebo

Interventions

REGN5713 DRUG

Administered subcutaneously

REGN5713-5714-5715

REGN5714 DRUG

Administered subcutaneously

REGN5713-5714-5715

REGN5715 DRUG

Administered subcutaneously

REGN5713-5714-5715

Placebo DRUG

Placebo that replaces REGN5713-5714-5715

Placebo Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years
• Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol
• Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol
• Willing and able to comply with clinic visits and study-related procedures

You may not qualify if:

• Participation in a prior REGN5713-5714-5715 clinical trial
• Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator
• Participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator
• Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. Participants may be re-evaluated for eligibility after symptoms resolve
• Documentation of active SARS-CoV-2 infection, as defined in the protocol
• A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year
• History of birch allergy immunotherapy as defined in the protocol
• Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 months prior to screening

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (37)

Regeneron Study Site

Bangor, Maine, 04401, United States

Location

Regeneron Study Site

Baltimore, Maryland, 21224, United States

Location

Regeneron Study Site

Plymouth, Minnesota, 55441, United States

Location

Regeneron Study Site

Columbia, Missouri, 65212, United States

Location

Regeneron Study Site

St Louis, Missouri, 63141, United States

Location

Regeneron Study Site

Missoula, Montana, 59808, United States

Location

Regeneron Study Site

Verona, New Jersey, 07044, United States

Location

Regeneron Study Site

Great Neck, New York, 11021, United States

Location

Regeneron Study Site

Cincinnati, Ohio, 45231, United States

Location

Regeneron Study Site

Toledo, Ohio, 43617, United States

Location

Regeneron Study Site

Portland, Oregon, 97202, United States

Location

Regeneron Study Site

Pittsburgh, Pennsylvania, 15241, United States

Location

Regeneron Study Site

Lincoln, Rhode Island, 02865, United States

Location

Regeneron Study Site

Greenfield, Wisconsin, 53228, United States

Location

Regeneron Study Site

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Regeneron Study Site

Leuven, Vlaams Brabant, 3000, Belgium

Location

Regeneron Study Site

Kingston, Ontario, K7L 2V7, Canada

Location

Regeneron Study Site

London, Ontario, N5W 6A2, Canada

Location

Regeneron Study Site

Ottawa, Ontario, K1G 6C6, Canada

Location

Regeneron Study Site

Toronto, Ontario, M4V 1R2, Canada

Location

Regeneron Study Site

Toronto, Ontario, M5B 1W8, Canada

Location

Regeneron Study Site

Toronto, Ontario, M5G 1E2, Canada

Location

Regeneron Study Site

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Regeneron Study Site

Québec, G1V 4M6, Canada

Location

Regeneron Study Site

Hvidovre, Capital, 2650, Denmark

Location

Regeneron Study Site

Hellerup, Copenhagen Surroundings, 2900, Denmark

Location

Regeneron Study Site

Vejle, South Jutland, 7100, Denmark

Location

Regeneron Study Site

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Regeneron Study Site

Stuttgart, Baden-Wurttemberg, 70374, Germany

Location

Regeneron Study Site

Dreieich, Hesse, 63303, Germany

Location

Regeneron Study Site

Wiesbaden, Hesse, 65183, Germany

Location

Regeneron Study Site

Duisburg, North Rhine-Westphalia, 47051, Germany

Location

Regeneron Study Site

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Regeneron Study Site

Dresden, Saxony, 01139, Germany

Location

Regeneron Study Site

Berlin, 10117, Germany

Location

Regeneron Study Site

Berlin, 14050, Germany

Location

Regeneron Study Site

Hamburg, 22549, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctival Diseases; Eye Diseases

Results Point of Contact

• Title: Clinical Trial Management
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 14, 2021
• Study Start: January 14, 2021
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: October 27, 2022
• Results First Posted: October 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

DK (3); US (14); BE (2); CA (8); DE (10)