Trial · NCT04709575
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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 | |
| Secondary | Serum Concentration of REGN5714 Over the Study Duration | Up to Day 127 | |
| Secondary | Serum Concentration of REGN5715 Over the Study Duration | Up to Day 127 | |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
| Secondary | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT04709575/registered