Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants

NCT05430919 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: R5713-5714-5715-ALG-21111
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 3

Brief Summary

Primary objective: To assess the efficacy of a single dose of the anti- Bet v 1 monoclonal antibodies (mAb(s ) in the reduction of allergic nasal symptoms during an out-of-season birch allergen environmental exposure unit (EEU) challenge in participants receiving REGN5713-5714-5715 versus placebo (Part A)

Conditions

Allergic Rhinitis; Conjunctivitis

Keywords

Birch Allergy; Birch Pollen Season; Monoclonal antibody(ies); Oak Pollen Season; Subcutaneous immunotherapy; Skin Prick Test

Outcome Measures

Primary Outcomes (1)

• Mean Total Nasal Symptom Score (TNSS) (2 to 6 Hours) During Out-of-season Birch Allergen Environmental Exposure Unit (EEU) Challenge (REGN5713-5714-5715 vs. Placebo) at Day 29

  TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.

  Day 29 from randomization (Out-of-season)

Secondary Outcomes (48)

• Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29

  Day 29 from randomization (Out-of-season)

• Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

  Day 57 and Day 85, from randomization (Out-of-season)

• Mean Total Ocular Symptom Score (TOSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

  Day 29 from randomization (Out-of-season)

• Mean TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85

  Day 57 and Day 85, from randomization (Out-of-season)

• Mean Total Symptom Score (TSS) (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 29

  Day 29 from randomization (Out-of-season)

Study Arms (4)

REGN5713-5714-5715

EXPERIMENTAL

3-mAb

Drug: REGN5713; Drug: REGN5714; Drug: REGN5715

REGN5713-5715

EXPERIMENTAL

2-mAb

Drug: REGN5713; Drug: REGN5715; Other: Placebo

REGN5715

EXPERIMENTAL

1-mAb

Drug: REGN5715; Other: Placebo

Matching Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

REGN5713 DRUG

Administered subcutaneously (SC)

REGN5713-5714-5715; REGN5713-5715

REGN5714 DRUG

Administered SC

REGN5713-5714-5715

REGN5715 DRUG

Administered SC

REGN5713-5714-5715; REGN5713-5715; REGN5715

Placebo OTHER

Administered SC

Matching Placebo; REGN5713-5715; REGN5715

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented or participant-reported history of birch tree pollen-triggered allergic-rhinitis (AR) symptoms with or without conjunctivitis (for at least 2 seasons)
• Positive Skin prick test (SPT) with birch tree pollen extract (mean wheal diameter at least 5 mm greater than a negative control) in screening period
• Positive allergen-specific immunoglobulin E (sIgE) tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L) in screening period
• Demonstrated TNSS ≥ 6 out of 12 on at least 2 time points during the birch EEU exposure challenge in screening period

You may not qualify if:

• Participation in a prior REGN5713-5714-5715 clinical trial and received REGN5713-5714-5715 antibodies (receipt of placebo in a previous trial is allowed)
• Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season, or due to daily contact with other non-birch related allergens causing symptoms that are expected to coincide or potentially interfere with the study EEU assessments or with the birch pollen season, as assessed by the investigator
• Participants who anticipate major changes in allergen exposure during the birch pollen season that are expected to coincide with study assessments or planned travel that is expected to interfere with the study assessments, as assessed by the investigator (eg. anticipated travel during planned EEU sessions or birch pollen season)
• Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections within 4 weeks prior to screening visit 1. Patients may be re-evaluated for eligibility after resolution of symptoms and specified duration.
• History of significant, recurrent sinusitis, defined as at least 3 episodes requiring antibiotic treatment per year for the last 2 years
• Abnormal lung function as judged by the investigator with Forced Expiratory Volume (FEV1) \<75% of predicted at screening or randomization
• A clinical history of moderate to severe asthma, uncontrolled asthma, global initiative for asthma \[GINA\] steps 3 to 5, history of life-threatening asthma, asthma exacerbations due to tree pollen allergy within 2 prior seasons, \>2 asthma exacerbations requiring systemic steroids in past 12 months, asthma related emergency care or hospitalization within 12 months prior to screening, as defined in the protocol.
• History of birch or other tree allergen immunotherapy in the 3 years prior to screening.
• Use of anti-IgE or other biological therapy (including but not limited to anti IL-5, anti IL-4) that interferes with type 2 disease within 6 months prior to screening visit 1.
• Allergen-specific immunotherapy with any allergen other than birch or other trees at screening.
• History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease,
• Any malignancy within the past 5 years, except for basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus that have been resected, with no evidence of local recurrence or metastatic disease for 3 years.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (3)

Kingston General Health Research Institute

Kingston, Ontario, K7L 2V7, Canada

Location

Inflamax Research Limited DBA Cliantha Research

Mississauga, Ontario, L4W 1A4, Canada

Location

Clinique Specialisee en Allergie de la Capitale

Québec, Quebec, G1V4W2, Canada

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 Trials Administrator
• 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 2
• 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: June 20, 2022
• First Posted: June 24, 2022
• Study Start: August 15, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-10

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

CA (3)