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

Phase 3

Completed

• Conditions: Allergic Rhinitis; Conjunctivitis
• Interventions: Drug: Placebo; Drug: REGN5713; Drug: REGN5714; Drug: REGN5715

• Registration Number: NCT04709575
• Lead Sponsor: Regeneron Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2021-01-12
• Study Start: 2021-01-14
• Study First Posted: 2021-01-14
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Results First Submitted: 2022-08-22
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-30
• Last Update Submitted: 2022-09-30
• Results First Posted: 2022-10-27
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 353

Inclusion Criteria

Not provided

Exclusion Criteria

1. Participation in a prior REGN5713-5714-5715 clinical trial
2. 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
3. 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
4. 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
5. Documentation of active SARS-CoV-2 infection, as defined in the protocol
6. A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year
7. History of birch allergy immunotherapy as defined in the protocol
8. Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 months prior to screening

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Only	Placebo	Placebo matching REGN5713-5714-5715 administered subcutaneously
REGN5713-5714-5715	REGN5713	REGN5713-5714-5715 administered subcutaneously
REGN5713-5714-5715	REGN5714	REGN5713-5714-5715 administered subcutaneously
REGN5713-5714-5715	REGN5715	REGN5713-5714-5715 administered subcutaneously

Primary Outcome Measures

Name	Time	Method
Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	Until the end of Birch Pollen Season, up to Week 16	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).

Secondary Outcome Measures

Name	Time	Method
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	TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)
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 nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.
Serum Concentration of REGN5715 Over the Study Duration	Up to Day 127
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	Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)
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	The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum)
Serum Concentration of REGN5713 Over the Study Duration	Day 0, Day 56, Day 112
Serum Concentration of REGN5714 Over the Study Duration	Up to Day 127
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study	Up to Day 127	Number of participants with any Treatment Emergent Adverse Events (TEAEs) from participating in study
Number of Participants With Serious TEAEs Throughout the Study	Up to Day 127	Number of participants with any Serious Treatment Emergent Adverse Events (TEAEs) from participating in study
Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	Baseline through Day 127	Number of participants who showed change from baseline to the end of the study in Birch Skin Prick Test (SPT) Mean Wheal Diameter, in participants who received REGN5713-5714-5715 compared to placebo
Percent Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	Baseline through Day 127
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study	Up to Day 127	Percentage of participants who developed antibodies to intervention provided during study
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study	Up to Day 127	Percentage of participants who developed antibodies to intervention provided during study
Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study	Up to Day 127	Percentage of participants who developed antibodies to intervention provided during study
Number of "Well Days"	Until the end of Birch Pollen Season, up to Week 16	"Well Days" are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is ≤2/18

Trial Locations

Locations (1)

Regeneron Study Site; 🇩🇪 Hamburg, Germany