Trial · NCT04709575
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
NCT04709575, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2022-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis. Trials, record NCT04709575. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04709575
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
- NCT number
- NCT04709575
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 353 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Allergic Rhinitis, Conjunctivitis
- Interventions
- REGN5713, REGN5714, REGN5715, Placebo
- First posted
- 2021-01-14
- Last updated
- 2022-10-27
- Other registries' IDs
- eudract:2020-004094-52
- Results first posted
- 2022-10-27
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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) |
| 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 | 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. |
| 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 | 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) |
| 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 | 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) |
| Secondary | 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 |
| Secondary | 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 |
| 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 | 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 |
| 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 | Baseline through Day 127 | |
| Secondary | Serum Concentration of REGN5713 Over the Study Duration | Day 0, Day 56, Day 112 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season. | Scores on a Scale | LEAST_SQUARES_MEAN |
| 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 | Until the end of Birch Pollen Season, up to Week 16 | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Scores on a Scale | LEAST_SQUARES_MEAN |
| 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 | Until the end of Birch Pollen Season, up to Week 16 | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Until the end of Birch Pollen Season, up to Week 16 | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Score on a scale | LEAST_SQUARES_MEAN |
| 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 | Until the end of Birch Pollen Season, up to Week 16 | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study | Up to Day 127 | All participants in Safety Analysis Set (SAF) who received study drug and were recorded, if symptoms were displayed or not | Count of Participants | NUMBER |
| SECONDARY | Number of Participants With Serious TEAEs Throughout the Study | Up to Day 127 | All participants in Safety Analysis Set (SAF) who received study drug and were recorded, if symptoms were displayed or not | Count of Participants | NUMBER |
| 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 | Baseline through Day 127 | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | millimeters | LEAST_SQUARES_MEAN |
| 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 | Baseline through Day 127 | All randomized participants with at least 1 e-diary entry with symptoms or medication score recorded during the birch pollen season | Percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Serum Concentration of REGN5713 Over the Study Duration | Day 0, Day 56, Day 112 | All randomized and treated participants who recorded and contributed to each timepoint (+/- 14 days) | mg/L | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | REGN5713-5714-5715 | 7.503 | Standard Error 0.6545 | Scores on a Scale | |
| Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo | Placebo Only | 8.498 | Standard Error 0.6534 | Scores on a Scale | |
| 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 | REGN5713-5714-5715 | 5.19 | Standard Error 0.397 | Scores on a Scale | |
| 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 | Placebo Only | 5.62 | Standard Error 0.396 | Scores on a Scale | |
| 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 | REGN5713-5714-5715 | 3.76 | Standard Error 0.278 | Score on a scale | |
| 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 | Placebo Only | 4.00 | Standard Error 0.277 | Score on a scale | |
| 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 | REGN5713-5714-5715 | 1.43 | Standard Error 0.150 | Score on a scale | |
| 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 | Placebo Only | 1.62 | Standard Error 0.150 | Score on a scale | |
| 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 | REGN5713-5714-5715 | 2.316 | Standard Error 0.3993 | Score on a Scale | |
| 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 | Placebo Only | 2.882 | Standard Error 0.3986 | Score on a Scale |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | REGN5713-5714-5715 | 176 | |
| Overall Study | STARTED | Placebo Only | 177 | |
| Overall Study | COMPLETED | REGN5713-5714-5715 | 166 | |
| Overall Study | COMPLETED | Placebo Only | 172 | |
| Overall Study | NOT COMPLETED | REGN5713-5714-5715 | 10 | |
| Overall Study | NOT COMPLETED | Placebo Only | 5 |
Source ClinicalTrials.gov
Adverse events12
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 | Vaccination complication | Injury, poisoning and procedural complications | Placebo | 22 | 176 | 29 |
| other | Vaccination complication | Injury, poisoning and procedural complications | R5713-5714-5715 900 mg | 17 | 173 | 26 |
| other | Headache | Nervous system disorders | Placebo | 19 | 176 | 22 |
| other | Headache | Nervous system disorders | R5713-5714-5715 900 mg | 15 | 173 | 19 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 9 | 176 | 9 |
| other | Nasopharyngitis | Infections and infestations | R5713-5714-5715 900 mg | 5 | 173 | 5 |
| serious | Appendicitis | Infections and infestations | Placebo | 0 | 176 | 0 |
| serious | Appendicitis | Infections and infestations | R5713-5714-5715 900 mg | 1 | 173 | 1 |
| serious | Thermal burn | Injury, poisoning and procedural complications | Placebo | 0 | 176 | 0 |
| serious | Thermal burn | Injury, poisoning and procedural complications | R5713-5714-5715 900 mg | 1 | 173 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 176 |
| Total, all-cause mortality | R5713-5714-5715 900 mg | 0 | 173 |
| Total, other adverse events | Placebo | 43 | 176 |
| Total, other adverse events | R5713-5714-5715 900 mg | 32 | 173 |
| Total, serious adverse events | Placebo | 0 | 176 |
| Total, serious adverse events | R5713-5714-5715 900 mg | 3 | 173 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| R5713-5714-5715 900 mg vs Placebo: deaths from any cause | Trial comparisons |
| R5713-5714-5715 900 mg vs Placebo: serious adverse events | Trial comparisons |
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.
GET https://conductscience.org/api/trials/v1/NCT04709575
GET https://conductscience.org/api/trials/v1/NCT04709575/results?page=2