Trial · NCT04981717
A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat
NCT04981717, Phase 3, Terminated, Regeneron Pharmaceuticals; results first posted 2024-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat. Trials, record NCT04981717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04981717
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat
- NCT number
- NCT04981717
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 446 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Allergic Rhinitis Due to Cat Allergy
- Interventions
- REGN1908-1909, Matching Placebo
- First posted
- 2021-07-29
- Last updated
- 2024-06-11
- Other registries' IDs
- eudract:2021-002089-42
- Results first posted
- 2024-06-11
- Limitations and caveats
- The study met prespecified interim futility criteria for CSMS and TNSS, therefore, an efficacy analysis was not performed for the primary and secondary endpoints as specified in the protocol
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daily Combined Symptom and Medication Score (CSMS) Averaged Over Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | 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 | Daily Total Nasal Symptom Score (TNSS) Averaged Over the Last 12 Weeks of Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | 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 | Percent Change From Pre-treatment Baseline in Average CSMS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | |
| Secondary | Percent Change From Pre-treatment Baseline in Average TNSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | |
| Secondary | Daily Total Symptom Score (TSS) Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | 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 | Percent Change From Pre-treatment Baseline in Average TSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | |
| Secondary | Percent Change From Baseline to the End of Treatment in Cat Skin Prick Test (SPT) Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo | Week 60 | |
| Secondary | Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score \[TNSS\] and total ocular symptom score \[TOSS\]) plus daily medication score (DMS). Scores ranging between 0 (none) and 38 (severe). |
| Secondary | Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | The TNSS ranges 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 nasal congestion, itching, and runny nose, and sneezing. |
| Secondary | Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | The combined symptom and medication score (CSMS) is defined as the daily combined allergic rhinitis and conjunctivitis total symptom score (TSS: calculated as the sum of total nasal symptom score \[TNSS\] and total ocular symptom score \[TOSS\]) plus daily medication score (DMS). |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Daily Combined Symptom and Medication Score (CSMS) Averaged Over Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | ||
| SECONDARY | Daily Total Nasal Symptom Score (TNSS) Averaged Over the Last 12 Weeks of Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | ||
| SECONDARY | Percent Change From Pre-treatment Baseline in Average CSMS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | ||
| SECONDARY | Percent Change From Pre-treatment Baseline in Average TNSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | ||
| SECONDARY | Daily Total Symptom Score (TSS) Averaged Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | ||
| SECONDARY | Percent Change From Pre-treatment Baseline in Average TSS Over the Last 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 48 to 60 | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | ||
| SECONDARY | Percent Change From Baseline to the End of Treatment in Cat Skin Prick Test (SPT) Mean Wheal Diameter in Patients Who Receive REGN1908-1909 Versus Placebo | Week 60 | Due to the early termination, the study was not fully enrolled, the primary endpoint and all secondary endpoints planned for weeks 48 - 60 could not be evaluated. Data not collected. | ||
| SECONDARY | Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS | Average Score | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Weeks 0 to 12 | The full analysis set (FAS) includes all randomized patients; it is based on the treatment allocated (as randomized). Efficacy endpoints will be analyzed using the FAS. | Percent Change | MEAN |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | REGN1908-1909 | 16.184 | Standard Error 0.9370 | Scores on a Scale | |
| Daily CSMS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Placebo | 15.290 | Standard Error 0.9173 | Scores on a Scale | |
| Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | REGN1908-1909 | 6.18 | Standard Error 0.320 | Average Score | |
| Daily TNSS Averaged Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Placebo | 5.88 | Standard Error 0.314 | Average Score | |
| Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | REGN1908-1909 | -29.25 | Standard Deviation 4.363 | Percent Change | |
| Percent Change From Pre-treatment Baseline in Average CSMS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Placebo | -33.16 | Standard Deviation 28.299 | Percent Change | |
| Percent Change From Pre-treatment Baseline in Average TNSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | REGN1908-1909 | -26.77 | Standard Deviation 29.471 | Percent Change | |
| Percent Change From Pre-treatment Baseline in Average TNSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Placebo | -30.33 | Standard Deviation 27.976 | Percent Change | |
| Percent Change From Pre-treatment Baseline in Average TSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | REGN1908-1909 | -27.25 | Standard Deviation 30.185 | Percent | |
| Percent Change From Pre-treatment Baseline in Average TSS Over the Initial 12 Weeks of the Treatment Period in Patients Who Receive REGN1908-1909 Versus Placebo | Placebo | -31.16 | Standard Deviation 28.390 | Percent |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 222 | |
| Overall Study | STARTED | REGN1908-1909 | 224 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | REGN1908-1909 | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 214 | |
| Overall Study | NOT COMPLETED | REGN1908-1909 | 220 |
Source ClinicalTrials.gov
Adverse events14
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 | COVID-19 | Infections and infestations | Placebo | 28 | 222 | 29 |
| other | COVID-19 | Infections and infestations | R1908-1909 600 mg | 22 | 218 | 22 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 25 | 222 | 30 |
| other | Nasopharyngitis | Infections and infestations | R1908-1909 600 mg | 21 | 218 | 28 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 9 | 222 | 11 |
| other | Upper respiratory tract infection | Infections and infestations | R1908-1909 600 mg | 14 | 218 | 16 |
| serious | Meniere's disease | Ear and labyrinth disorders | Placebo | 1 | 222 | 1 |
| serious | Meniere's disease | Ear and labyrinth disorders | R1908-1909 600 mg | 0 | 218 | 0 |
| serious | Gastrointestinal procedural complication | Injury, poisoning and procedural complications | Placebo | 1 | 222 | 2 |
| serious | Gastrointestinal procedural complication | Injury, poisoning and procedural complications | R1908-1909 600 mg | 0 | 218 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 222 |
| Total, all-cause mortality | R1908-1909 600 mg | 0 | 218 |
| Total, other adverse events | Placebo | 58 | 222 |
| Total, other adverse events | R1908-1909 600 mg | 54 | 218 |
| Total, serious adverse events | Placebo | 2 | 222 |
| Total, serious adverse events | R1908-1909 600 mg | 2 | 218 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| REGN1908-1909 vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Throughout the Study | Trial comparisons |
| REGN1908-1909 vs Placebo: Number of Participants With Adverse Event of Special Interests (AESIs) Throughout the Study | Trial comparisons |
| REGN1908-1909 vs Placebo: Incidence of Treatment-emergent ADAs to REGN1909 Throughout the Study | Trial comparisons |
| REGN1908-1909 vs Placebo: Incidence of Treatment-emergent Anti-drug Antibodies (ADAs) to REGN1908 Throughout the Study | Trial comparisons |
| R1908-1909 600 mg vs Placebo: deaths from any cause | Trial comparisons |
| REGN1908-1909 vs Placebo: Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs) Throughout the Study | Trial comparisons |
| R1908-1909 600 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/NCT04981717
GET https://conductscience.org/api/trials/v1/NCT04981717/registered?page=2