Trial · NCT05545072
Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT)
NCT05545072, Phase 3, Terminated, Emory University; results first posted 2025-05-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT). Trials, record NCT05545072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05545072
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Add-on Dupilumab for AFRS as Postoperative Therapy (ADAPT)
- NCT number
- NCT05545072
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 5 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Allergic Fungal Rhinosinusitis
- Interventions
- Dupilumab, Placebo, Intranasal Corticosteroid Sprays (INCS)
- First posted
- 2022-09-19
- Last updated
- 2025-05-08
- Results first posted
- 2025-05-08
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modified Lund-Kennedy (mLK) Score | Baseline and End of Treatment at Week 52 | The efficacy of dupilumab in controlling sinonasal inflammation and preventing nasal polyp recurrence after complete sinus surgery for allergic fungal rhinosinusitis (AFRS) is assessed by using the modified Lund-Kennedy score. The modified Lund-Kennedy score (mLK) is a validated measure of sinonasal inflammation, as evaluated by means of nasal endoscopy. The composite score ranges from 0 to 12, with an increasing score representing worsening inflammation among three separate findings (Nasal polyps, Discharge, Edema). Each finding is rated from 0 (absent) to 2 (severe). A ≥ 2-point increase from baseline total postoperative score represents a clinically significant worsening of sinonasal inflammation. |
| Primary | Incidence of Oral/Topical Corticosteroid Utilization Per Participant | Baseline and End of Treatment at Week 52 | The number of participants who, during study treatment and off-treatment follow-up, based on clinical evaluation, present worsening signs and/or symptoms and are started on oral corticosteroids rescue treatment. |
| Secondary | Prevalence of Revision Sinus Surgery for Recurrent Nasal Polyps, and Comparison of Survival Curves | Up to End of Treatment at Week 52 | Documentation of the number of revision sinus surgery per participant, that are deemed clinically necessary for the treatment of an acute exacerbation of chronic rhinosinusitis (AECRS) |
| Secondary | Endoscopic Nasal Polyp Score (NPS) | Baseline and End of Treatment at Week 52 | NPS is a physician-reported tool to grade the extent/severity of nasal polyps based on evaluation by nasal endoscopy. Each nostril is scored on a scale of 0 (no polyps visible) to 4 (massive polyposis completely obstructing the nasal cavity), with the total score being the sum of left and right nostril scores (range: 0-8). The total NPS is the sum of scores from the right and left nostrils. |
| Secondary | Percent Predicted Forced Vital Capacity (%FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Baseline and End of Treatment at Week 52 | Spirometry is a common office test used to assess how well the participant's lungs work by measuring how much air the participant inhales, how much the participant exhales, and how quickly the participant exhales. Forced vital capacity (FVC) refers to the maximal volume of air that can be expired following maximum inspiration. It is the total of tidal volume, inspiratory reserve volume, and expiratory reserve volume. The percent FVC is the FVC compared to a predicted FVC based on age, sex, and height. |
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Baseline and End of Treatment at Week 52 | Forced expiratory volume in one second (FEV1) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FEV1 is the amount of air forced from the lungs in one second. |
| Secondary | Forced Vital Capacity (FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Baseline and End of Treatment at Week 52 | Forced vital capacity (FVC) is measured during a spirometry test, also known as a pulmonary function test, which involves forcefully breathing out into a mouthpiece connected to a spirometer machine. FVC is the total amount of air exhaled during the FEV test. |
| Secondary | FEV1/FVC Ratio Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Baseline and End of Treatment at Week 52 | The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85, though this is age-dependent, values less than 0.70 are suggestive of airflow limitation with an obstructive pattern. |
| Secondary | Change in the Modified Lund-Kennedy (mLK) Radiologic Score | 52 weeks and 64 weeks | The mLK Radiologic scoring system assigns a value of 0, 1, or 2 to each of the following sinuses: maxillary, anterior ethmoid, posterior ethmoid, frontal, and sphenoid. Score assignments are 0 if the sinus is totally patent, 1 if the sinus is partially opacified, and 2 if the sinus is completely opacified. The osteomeatal complex is scored either 0 if not occluded or 2 if occluded. The maximum score for each side is thus 12, with a total score determined out of 24. Baseline Lund- MacKay (LM) scores will be counted as zero in accordance with recent sinus surgery. |
| Secondary | Endoscopic Nasal Polyp Score (NPS) | 52 weeks and 64 weeks | Endoscopic nasal polyp score is determined by the treating Investigator. Unlike prior studies of dupilumab in nasal polyps, researchers will separately record the Nasal Polyp Score for each side, with a maximum unilateral score of 4 (massive polyposis completely obstructing the nasal cavity). This is appropriate for monitoring efficacy in AFRS, as a subgroup of participants may present with unilateral disease. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Modified Lund-Kennedy (mLK) Score | Baseline and End of Treatment at Week 52 | Data are not available for the calculation of the mLK score as the study was terminated before central reader scoring of the nasal endoscopy. | ||
| PRIMARY | Incidence of Oral/Topical Corticosteroid Utilization Per Participant | Baseline and End of Treatment at Week 52 | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Prevalence of Revision Sinus Surgery for Recurrent Nasal Polyps, and Comparison of Survival Curves | Up to End of Treatment at Week 52 | Revision Surgeries per participant | MEAN | |
| SECONDARY | Endoscopic Nasal Polyp Score (NPS) | Baseline and End of Treatment at Week 52 | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Score on a scale | MEAN |
| SECONDARY | Percent Predicted Forced Vital Capacity (%FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Baseline and End of Treatment at Week 52 | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | %FVC | MEAN |
| SECONDARY | Forced Expiratory Volume in 1 Second (FEV1) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Baseline and End of Treatment at Week 52 | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | Liter | MEAN |
| SECONDARY | Forced Vital Capacity (FVC) Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Baseline and End of Treatment at Week 52 | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | liter | MEAN |
| SECONDARY | FEV1/FVC Ratio Following Sinus Surgery in the Subgroup of Participants With Asthma (~25%) | Baseline and End of Treatment at Week 52 | Participants were unable to complete the study visits as scheduled at 52 weeks due to the premature termination of the study. Data is reported up to the time point completed by all participants. | FEV1/FVC | MEAN |
| SECONDARY | Change in the Modified Lund-Kennedy (mLK) Radiologic Score | 52 weeks and 64 weeks | Data for the calculation of the mLK score are not available, as the study was terminated prematurely before participants were able to complete the scheduled study visits at weeks 52 and 64. | ||
| SECONDARY | Endoscopic Nasal Polyp Score (NPS) | 52 weeks and 64 weeks | Participants were unable to complete the study visits as scheduled at 52 and 64 weeks due to the premature termination of the study. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Oral/Topical Corticosteroid Utilization Per Participant | Dupilumab | Baseline | 3 | Participants | |
| Incidence of Oral/Topical Corticosteroid Utilization Per Participant | Placebo | Baseline | 2 | Participants | |
| Incidence of Oral/Topical Corticosteroid Utilization Per Participant | Dupilumab | Week 12 | 0 | Participants | |
| Incidence of Oral/Topical Corticosteroid Utilization Per Participant | Placebo | Week 12 | 0 | Participants | |
| Incidence of Oral/Topical Corticosteroid Utilization Per Participant | Dupilumab | Week 24 | 0 | Participants | |
| Prevalence of Revision Sinus Surgery for Recurrent Nasal Polyps, and Comparison of Survival Curves | Dupilumab | 0 | Standard Deviation 0 | Revision Surgeries per participant | |
| Prevalence of Revision Sinus Surgery for Recurrent Nasal Polyps, and Comparison of Survival Curves | Placebo | 0 | Standard Deviation 0 | Revision Surgeries per participant | |
| Endoscopic Nasal Polyp Score (NPS) | Dupilumab | Baseline | 4.33 | Standard Deviation 0.47 | Score on a scale |
| Endoscopic Nasal Polyp Score (NPS) | Placebo | Baseline | 5 | Standard Deviation 1 | Score on a scale |
| Endoscopic Nasal Polyp Score (NPS) | Dupilumab | Week 12 | 1 | Standard Deviation 0 | Score on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dupilumab | 3 | |
| Overall Study | STARTED | Placebo | 2 | |
| Overall Study | COMPLETED | Dupilumab | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Dupilumab | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events8
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 | Headache | Nervous system disorders | Dupilumab | 1 | 3 | |
| other | Headache | Nervous system disorders | Placebo | 0 | 2 | |
| other | Injection Site Reaction | Skin and subcutaneous tissue disorders | Dupilumab | 2 | 3 | |
| other | Injection Site Reaction | Skin and subcutaneous tissue disorders | Placebo | 2 | 2 | |
| other | Joint Pain | Musculoskeletal and connective tissue disorders | Dupilumab | 1 | 3 | |
| other | Joint Pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 2 | |
| other | Other | General disorders | Dupilumab | 2 | 3 | |
| other | Other | General disorders | Placebo | 2 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dupilumab | 0 | 3 |
| Total, all-cause mortality | Placebo | 0 | 2 |
| Total, other adverse events | Dupilumab | 2 | 3 |
| Total, other adverse events | Placebo | 2 | 2 |
| Total, serious adverse events | Dupilumab | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 2 |
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 |
|---|---|
| Dupilumab vs Placebo: deaths from any cause | Trial comparisons |
| Dupilumab 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/NCT05545072
GET https://conductscience.org/api/trials/v1/NCT05545072/results?page=2