Trial · NCT03688555
A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis
NCT03688555, Phase 2, Completed, Idorsia Pharmaceuticals Ltd.; results first posted 2022-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis. Trials, record NCT03688555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03688555
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Effect of ACT-774312 in Subjects With Bilateral Nasal Polyposis
- NCT number
- NCT03688555
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Conditions
- Bilateral Nasal Polyposis
- Interventions
- ACT-774312, Placebo
- First posted
- 2018-09-28
- Last updated
- 2022-04-11
- Other registries' IDs
- eudract:2018-000851-42
- Results first posted
- 2022-02-01
- Limitations and caveats
The study was initially planned as a single-center study. The protocol had to be updated accordingly for approvals for the second site in Germany.~The p-values need to be cautiously interpreted due to the small study population size.~Recruitment was put on hold on during the COVID-19 pandemic from 30 March to 28 May 2020 in Germany and from 31 March 2020 to 11 June 2020 in Belgium. Recruitment was subsequently restarted.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 12 in Nasal Polyp Score as Measured by Nasal Endoscopy (Assessed Centrally) | Pre-dose (Baseline on Day 1) and Week 12 | Independent reviewers, blinded to treatment, reviewed image recordings of nasal endoscopies to determine total endoscopic nasal polyp score based on nasal polyp size. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8, higher scores indicate greater disease severity. Data up to Week 12 were included in the analyses. The Day 1 value was the baseline. Change from Baseline = (Post-baseline visit value) minus (Baseline visit value). A negative change indicates worsening. |
| Secondary | Change From Baseline to Week 12 in Sinus Opacifications as Assessed by Computed Tomography Scan Using the Modified Lund Mackay Score (Assessed Centrally) | Pre-dose (Baseline on Day 1) and Week 12 | Independent blinded reviewers reviewed image recordings of the computed tomography scan. The modified Lund Mackay Score scores were given for the degree of opacification and their location in the sinus. The right and left sinuses are divided into 6 portions, i.e., maxillary sinus, anterior ethmoid sinuses, posterior ethmoid sinuses, sphenoid sinus, frontal sinus, and ostiomeatal complex (OMC). The OMC is given a score of 0 (no obstruction) or 1 (obstruction) for the frontal recess, middle meatus, infundibulum, and the sphenoethmoidal recess channels. The total score is the sum of the right and left nostril scores and range from 0 to a maximum of 48. A positive change from baseline (Day 1) indicates a worsening. Change in the modified Lund-Mackay score = modified Lund-Mackay score at Week 12 minus the modified Lund-Mackay score at baseline. A positive change from baseline indicated a worsening in the modified Lund-Mackay Score at Week 12 compared to baseline. |
| Secondary | Change From Baseline to Week 12 in the Volume of Air in the Left Maxillary Sinus | Pre-dose (Baseline on Day 1) and Week 12 | Independent reviewers, blinded to treatment, reviewed image recordings of the computed tomography scan and performed 3D volumetric measurements of the left maxillary sinus. Absolute changes from baseline were calculated for volume of air (mL). Change in 3D volumetric measurement = (3D volumetric measurement at Week 12) minus (3D volumetric measurement at baseline). A positive change from baseline indicates that more volume for air is in the left maxillary sinus since the baseline visit. More volume of air indicates that the polyposis is improving in the left maxillary sinus. |
| Secondary | Change From Baseline to Week 12 in the Volume of Air in the Right Maxillary Sinus | Pre-dose (Baseline on Day 1) and Week 12 | Independent reviewers, blinded to treatment, reviewed image recordings of the computed tomography scan and performed 3D volumetric measurements of the right maxillary sinus. Absolute changes from baseline were calculated for the volume of air (mL) in the right maxillary sinus: Change in 3D volumetric measurement = (3D volumetric measurement at Week 12) minus (3D volumetric measurement at baseline). A positive change from baseline indicates that more volume for air is in the right maxillary sinus since the baseline visit. More volume of air indicates that the polyposis is improving in the right maxillary sinus. |
| Secondary | Change From Baseline to Week 12 in the Left Maxillary Sinus Mucosal Volume | Pre-dose (Baseline on Day 1) and Week 12 | Independent reviewers, blinded to treatment, reviewed image recordings of the computed tomography scan and performed 3D volumetric measurements of the left maxillary sinus. Absolute changes from baseline were calculated for the volume of air (mL) in the left maxillary sinus: Change in 3D volumetric measurement = (3D volumetric measurement at Week 12) minus (3D volumetric measurement at baseline). A negative change from baseline indicates that the left maxillary sinus mucosal volume has decreased since the baseline visit. More mucosal volume, a positive change, indicates that the polyposis is worsening in the left maxillary sinus. |
| Secondary | Change From Baseline to Week 12 in the Right Maxillary Sinus Mucosal Volume | Pre-dose (Baseline on Day 1) and Week 12 | Independent reviewers, blinded to treatment, reviewed image recordings of the computed tomography scan and performed 3D volumetric measurements of the right maxillary sinus. Absolute changes from baseline were calculated for the volume of air (mL) in the right maxillary sinus: Change in 3D volumetric measurement = (3D volumetric measurement at Week 12) minus (3D volumetric measurement at baseline). A negative change from baseline indicates that the right maxillary sinus mucosal volume has decreased since the baseline visit. More mucosal volume, a positive change, indicates that the polyposis is worsening in the right maxillary sinus. |
| Secondary | Change From Baseline to Week 12 in the University of Pennsylvania Smell Identification Test | Pre-dose (Baseline on Day 1) and Week 12 | The UPSIT (University of Pennsylvania Smell Identification Test) is a test that measures an individual's ability to detect odors. It consists of 4 workbooks of 10 pages each. On each page there is a different "scratch and sniff" strip which is embedded with a micro-encapsulated odorant and a question regarding the smell detected with a four-choice option for the response. The total number of questions in the UPSIT is 40. The number of correct responses regarding the smells being experienced is summed to provide a total score that ranges from 0 to 40, with a higher score indicating a better sense of smell. Absolute changes from baseline to Week 12 was calculated as follows: Change in UPSIT score = (UPSIT score at Week 12) minus (UPSIT score at baseline). A positive change from baseline in the UPSIT score is considered a favorable outcome. |
| Secondary | Change From Baseline in the Visual Analog Scale Symptoms Score | Baseline, Week 2, Week 4, Week 8, Week 12 and Week 16 (End-of-Study) | The participant was asked to score on a Visual Analog Scale (VAS) the answer to the question: "How troublesome are your symptoms?" (for the 5 following symptoms: nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain). The VAS ranges from 0 (Not at all troublesome) to 100 (Extremely troublesome). The sum of the score of all symptoms were added to a total VAS score which ranged from 0 to 500. The higher the VAS score the more troublesome the symptoms. Absolute changes from baseline to Weeks 2, 4, 8, 12, and End of Study are calculated as follows: Change in total VAS score = Change in total VAS score = (Total VAS score at visit) minus (Total VAS score at baseline). A negative change from baseline indicates an improvement.. A negative change from baseline indicates an improvement. |
| Secondary | Physician Global Assessment of Change in Disease Severity | Week 2, Week 4, Week 8, Week 12, and Week 16 (End-of-Study) | The Physician Global Assessment of Disease Severity questionnaire (PGAC-DS) was completed by the physician at Visit 2 and at each subsequent site visit until the End-of-Study (Week 16). The PGAC-DS questionnaire is a self-administered 1-item questionnaire designed to assess the physician's impression of change in disease severity since study treatment start. The physician rated the change since the participant study treatment start. The physician rated the change since the participant started study treatment on a 7-point scale. The rating for the overall score is: 'very much improved' (is scored 1), 'much improved' (is scored 2), 'minimally improved' (is scored 3), 'no change' (is scored 4), 'minimally worse' (is scored 5), 'much worse' (is scored 6), or 'very much worse' (is scored 7). |
| Secondary | Change From Baseline in the Sino-Nasal Outcome Test | Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16 (End-of-Study) | SNOT-22 (Sino-Nasal Outcome Test) is a disease specific quality of life questionnaire measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant was asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110. Higher total scores on the SNOT-22 imply greater impact on Quality of Life. Absolute changes from baseline to Weeks 2, 4, 8, 12, and 16 were calculated as follows: Change in SNOT-22 score = (SNOT-22 score at visit) minus (SNOT-22 score at baseline). A negative change from baseline in SNOT-22 is considered a favorable outcome. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 12 in Nasal Polyp Score as Measured by Nasal Endoscopy (Assessed Centrally) | Pre-dose (Baseline on Day 1) and Week 12 | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in Sinus Opacifications as Assessed by Computed Tomography Scan Using the Modified Lund Mackay Score (Assessed Centrally) | Pre-dose (Baseline on Day 1) and Week 12 | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Volume of Air in the Left Maxillary Sinus | Pre-dose (Baseline on Day 1) and Week 12 | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | milliliter(s) | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Volume of Air in the Right Maxillary Sinus | Pre-dose (Baseline on Day 1) and Week 12 | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | milliliter(s) | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Left Maxillary Sinus Mucosal Volume | Pre-dose (Baseline on Day 1) and Week 12 | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | milliliter(s) | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the Right Maxillary Sinus Mucosal Volume | Pre-dose (Baseline on Day 1) and Week 12 | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | milliliter(s) | MEAN |
| SECONDARY | Change From Baseline to Week 12 in the University of Pennsylvania Smell Identification Test | Pre-dose (Baseline on Day 1) and Week 12 | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Visual Analog Scale Symptoms Score | Baseline, Week 2, Week 4, Week 8, Week 12 and Week 16 (End-of-Study) | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | score on a scale | MEAN |
| SECONDARY | Physician Global Assessment of Change in Disease Severity | Week 2, Week 4, Week 8, Week 12, and Week 16 (End-of-Study) | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Sino-Nasal Outcome Test | Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16 (End-of-Study) | Per-protocol set. This analysis set includes all randomized participants who completed the treatment up to Week 12 without protocol deviations that may affect the evaluation of the primary endpoints. | score on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 12 in Nasal Polyp Score as Measured by Nasal Endoscopy (Assessed Centrally) | ACT-774312 | -0.23 | Standard Error 0.161 | score on a scale | |
| Change From Baseline to Week 12 in Nasal Polyp Score as Measured by Nasal Endoscopy (Assessed Centrally) | Placebo | -0.99 | Standard Error 0.253 | score on a scale | |
| Change From Baseline to Week 12 in Sinus Opacifications as Assessed by Computed Tomography Scan Using the Modified Lund Mackay Score (Assessed Centrally) | ACT-774312 | 0.86 | Standard Error 1.24 | score on a scale | |
| Change From Baseline to Week 12 in Sinus Opacifications as Assessed by Computed Tomography Scan Using the Modified Lund Mackay Score (Assessed Centrally) | Placebo | 4.84 | Standard Error 1.96 | score on a scale | |
| Change From Baseline to Week 12 in the Volume of Air in the Left Maxillary Sinus | ACT-774312 | 1.17 | Standard Deviation 1.72 | milliliter(s) | |
| Change From Baseline to Week 12 in the Volume of Air in the Left Maxillary Sinus | Placebo | -1.08 | Standard Deviation 2.48 | milliliter(s) | |
| Change From Baseline to Week 12 in the Volume of Air in the Right Maxillary Sinus | ACT-774312 | -0.94 | Standard Deviation 4.36 | milliliter(s) | |
| Change From Baseline to Week 12 in the Volume of Air in the Right Maxillary Sinus | Placebo | 1.77 | Standard Deviation 1.34 | milliliter(s) | |
| Change From Baseline to Week 12 in the Left Maxillary Sinus Mucosal Volume | ACT-774312 | -1.72 | Standard Deviation 1.72 | milliliter(s) | |
| Change From Baseline to Week 12 in the Left Maxillary Sinus Mucosal Volume | Placebo | -1.08 | Standard Deviation 2.48 | milliliter(s) |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Period | STARTED | Mometasone Furoate | 10 | |
| Run-in Period | STARTED | ACT-774312 | 0 | |
| Run-in Period | STARTED | Placebo | 0 | |
| Run-in Period | COMPLETED | Mometasone Furoate | 10 | |
| Run-in Period | COMPLETED | ACT-774312 | 0 | |
| Run-in Period | COMPLETED | Placebo | 0 | |
| Run-in Period | NOT COMPLETED | Mometasone Furoate | 0 | |
| Run-in Period | NOT COMPLETED | ACT-774312 | 0 | |
| Run-in Period | NOT COMPLETED | Placebo | 0 | |
| Treatment Period | STARTED | Mometasone Furoate | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events40
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 | Limb injury | Injury, poisoning and procedural complications | ACT-774312 | 0 | 7 | 0 |
| other | Limb injury | Injury, poisoning and procedural complications | Placebo | 1 | 3 | 1 |
| other | Nasal polyps | Respiratory, thoracic and mediastinal disorders | ACT-774312 | 1 | 7 | 1 |
| other | Nasal polyps | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 3 | 2 |
| other | Chronic rhinosinusitis with nasal polyps | Respiratory, thoracic and mediastinal disorders | ACT-774312 | 1 | 7 | 1 |
| other | Chronic rhinosinusitis with nasal polyps | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 3 | 0 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | ACT-774312 | 0 | 7 | 0 |
| other | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 3 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | ACT-774312 | 0 | 7 | 0 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 3 | 1 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACT-774312 | 0 | 7 |
| Total, all-cause mortality | Placebo | 0 | 3 |
| Total, other adverse events | ACT-774312 | 5 | 7 |
| Total, other adverse events | Placebo | 3 | 3 |
| Total, serious adverse events | ACT-774312 | 0 | 7 |
| Total, serious adverse events | Placebo | 0 | 3 |
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 |
|---|---|
| ACT-774312 vs Placebo: deaths from any cause | Trial comparisons |
| ACT-774312 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.
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