Trial · NCT05430919
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, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2024-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT05430919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05430919
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT05430919
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 217 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Allergic Rhinitis, Conjunctivitis
- Interventions
- REGN5713, REGN5714, REGN5715, Placebo
- First posted
- 2022-06-24
- Last updated
- 2024-11-19
- Results first posted
- 2024-11-19
Source ClinicalTrials.gov
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Day 29 from randomization (Out-of-season) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | 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. |
| Secondary | 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) | TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. |
| Secondary | 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) | TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. |
| Secondary | 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) | TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome |
| Secondary | Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85 | Day 57 and Day 85, from randomization (Out-of-season) | TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome |
| Secondary | Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | 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. |
| Secondary | Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | TOSS ranges from 0 (none) to 6 (severe): sum of 2 eye symptoms graded on a Likert scale each ranging from 0 (none) to 3 (severe) for itching/redness/gritty feeling \& tearing/watering; Higher score indicates worse outcome. |
| Secondary | Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | TSS ranges from 0 (none) to 18 (severe): sum of TNSS \& TOSS combined; Higher score indicates worse outcome |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 registered outcomesOutcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Day 29 from randomization (Out-of-season) | Randomized participants in only the REGN5713-5714-5715 and placebo arms were assessed for this endpoint. Missing values were imputed using multiple imputation (MI) method. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | Randomized participants in only the REGN5713-5715, REGN5715 and placebo arms were assessed for this endpoint. Missing values were imputed using multiple imputation (MI) method. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | The overall Number of Participants Analyzed is the total number of randomized participants in each treatment group. The Number Analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | All randomized participants. Missing values were imputed using multiple imputation (MI) method. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | The overall Number of Participants Analyzed is the total number of randomized participants in each treatment group. The Number Analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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) | All randomized participants. Missing values were imputed using multiple imputation (MI) method. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and at Day 85 | Day 57 and Day 85, from randomization (Out-of-season) | The overall Number of Participants Analyzed is the total number of randomized participants in each treatment group. The Number Analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pre-treatment Baseline in TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | The overall Number of Participants Analyzed is the total number of randomized participants in each treatment group. The Number Analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pre-treatment Baseline in TOSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | The overall Number of Participants Analyzed is the total number of randomized participants in each treatment group. The Number Analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Pre-treatment Baseline in TSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Days 29, 57 and 85 | Day 29, Day 57 and Day 85, from randomization (Out-of-season) | The overall Number of Participants Analyzed is the total number of randomized participants in each treatment group. The Number Analyzed for each timepoint is the number of participants with available observed data that were analyzed at that timepoint. | Scores on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 outcomesResults by group579
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | REGN5713-5714-5715 900 mg | 4.40 | Standard Error 0.377 | Scores on a Scale | |
| 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 | Placebo | 6.71 | Standard Error 0.380 | Scores on a Scale | |
| Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29 | REGN5713-5715 600 mg | 4.06 | Standard Error 0.406 | Scores on a Scale | |
| Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29 | REGN5715 300 mg | 5.20 | Standard Error 0.393 | Scores on a Scale | |
| Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge (Except for REGN5713-5714-5715) at Day 29 | Placebo | 6.71 | Standard Error 0.380 | Scores on a Scale | |
| Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85 | REGN5713-5714-5715 900 mg | Day 57 | 4.47 | Standard Error 0.458 | Scores on a Scale |
| Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85 | REGN5713-5715 600 mg | Day 57 | 3.89 | Standard Error 0.471 | Scores on a Scale |
| Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85 | REGN5715 300 mg | Day 57 | 5.58 | Standard Error 0.451 | Scores on a Scale |
| Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85 | Placebo | Day 57 | 6.29 | Standard Error 0.445 | Scores on a Scale |
| Mean TNSS (2 to 6 Hours) During Out-of-season Birch Allergen EEU Challenge at Day 57 and Day 85 | REGN5713-5714-5715 900 mg | Day 85 | 4.61 | Standard Error 0.511 | Scores on a Scale |
1 to 10 of 579Source ClinicalTrials.gov
See all 579 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | STARTED | REGN5715 300 mg | 55 | |
| Overall Study | STARTED | REGN5713-5715 600 mg | 52 | |
| Overall Study | STARTED | REGN5713-5714-5715 900 mg | 55 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | COMPLETED | REGN5715 300 mg | 54 | |
| Overall Study | COMPLETED | REGN5713-5715 600 mg | 51 | |
| Overall Study | COMPLETED | REGN5713-5714-5715 900 mg | 54 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | REGN5715 300 mg | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 3 | 55 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | REGN5715 300 mg | 8 | 55 | 8 |
| other | Upper respiratory tract infection | Infections and infestations | REGN5713-5715 600 mg | 5 | 51 | 7 |
| other | Upper respiratory tract infection | Infections and infestations | REGN5713-5714-5715 900 mg | 3 | 55 | 5 |
| other | COVID-19 | Infections and infestations | Placebo | 4 | 55 | 4 |
| other | COVID-19 | Infections and infestations | REGN5715 300 mg | 3 | 55 | 3 |
| other | COVID-19 | Infections and infestations | REGN5713-5715 600 mg | 5 | 51 | 5 |
| other | COVID-19 | Infections and infestations | REGN5713-5714-5715 900 mg | 2 | 55 | 2 |
| other | Headache | Nervous system disorders | Placebo | 8 | 55 | 16 |
| other | Headache | Nervous system disorders | REGN5715 300 mg | 4 | 55 | 7 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 55 |
| Total, all-cause mortality | REGN5715 300 mg | 0 | 55 |
| Total, all-cause mortality | REGN5713-5715 600 mg | 0 | 51 |
| Total, all-cause mortality | REGN5713-5714-5715 900 mg | 0 | 55 |
| Total, other adverse events | Placebo | 23 | 55 |
| Total, other adverse events | REGN5715 300 mg | 19 | 55 |
| Total, other adverse events | REGN5713-5715 600 mg | 20 | 51 |
| Total, other adverse events | REGN5713-5714-5715 900 mg | 19 | 55 |
| Total, serious adverse events | Placebo | 0 | 55 |
| Total, serious adverse events | REGN5715 300 mg | 0 | 55 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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