Phase 3
N=353
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
Allergic Rhinitis · Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT04709575 ↗Enrolled (actual)
353
Serious AEs
0.9%
Results posted
Oct 2022
Primary outcome: Primary: Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo — 7.503; 8.498 Scores on a Scale — p=0.0497
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- REGN5713 (Drug); REGN5714 (Drug); REGN5715 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo |
7.503; 8.498 | 0.0497 sig |
| SECONDARY 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 |
5.19; 5.62 | — |
| SECONDARY 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 |
3.76; 4.00 | — |
| SECONDARY 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 |
1.43; 1.62 | — |
| SECONDARY 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 |
2.316; 2.882 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study |
92; 85 | — |
| SECONDARY Number of Participants With Serious TEAEs Throughout the Study |
3; 0 | — |
| SECONDARY 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 |
-3.139; 0.553 | — |
| SECONDARY 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 |
-26.38; 8.17 | — |
| SECONDARY Serum Concentration of REGN5713 Over the Study Duration |
0; 10.0; 2.53 | — |
| SECONDARY Serum Concentration of REGN5714 Over the Study Duration |
0; 14.7; 4.82 | — |
| SECONDARY Serum Concentration of REGN5715 Over the Study Duration |
0; 16.6; 5.34 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study |
0; 0 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study |
0; 0 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study |
0; 0 | — |
| SECONDARY Number of "Well Days" |
8.3; 8.6 | — |
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.
Eligibility Criteria
Key Inclusion Criteria
- 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
Key Exclusion Criteria
- 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
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Data sourced from ClinicalTrials.gov (NCT04709575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.