Trial · NCT07903194
A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps
NCT07903194, Phase 3, Not yet recruiting, Shanghai Mabgeek Biotech.Co.Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps. Trials, record NCT07903194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903194
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps
- NCT number
- NCT07903194
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 210 participants, estimated
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Interventions
- MG-K10, Placebo, Mometasone Furoate Nasal Spray
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Bilateral Nasal Polyp Score (NPS) | Baseline and Week 24 | Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size. A negative change from baseline indicates improvement. |
| Primary | Change From Baseline in Nasal Congestion Score (NCS) | Baseline and Week 24 | Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement. |
| Secondary | Change From Baseline in Bilateral Nasal Polyp Score (NPS) (Other Than Week 24) | Baseline and Weeks 4, 8, 12, 16, 20, 28, 32, 40, 48, 52, and 60 | Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size. A negative change from baseline indicates improvement. |
| Secondary | Percentage of Participants With at Least a 1-Point Improvement From Baseline in Nasal Polyp Score (NPS) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size; a negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 1 point from baseline in NPS is calculated at each designated visit. |
| Secondary | Percentage of Participants With at Least a 2-Point Improvement From Baseline in Nasal Polyp Score (NPS) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size; a negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 2 points from baseline in NPS is calculated at each designated visit. |
| Secondary | Change From Baseline in Nasal Congestion Score (NCS) (Other Than Week 24) | Baseline and Weeks 4, 8, 12, 16, 20, 28, 32, 40, 48, 52, and 60 | Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement. |
| Secondary | Percentage of Participants With at Least a 1-Point Improvement From Baseline in Nasal Congestion Score (NCS) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 1 point from baseline in NCS is calculated at each designated visit. |
| Secondary | Change From Baseline in Total Symptom Score (TSS) | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Total Symptom Score (TSS) comprises three items: nasal congestion, loss of smell, and rhinorrhea; scores for anterior rhinorrhea and posterior rhinorrhea are averaged first. Each item is scored 0-3, with a total score of 0-9, where higher scores indicate more severe symptoms. Baseline is the mean of the week prior to randomization, and post-baseline is the mean of the two weeks prior to the visit. If fewer than 4 days are recorded within the 7 days prior to randomization, baseline is the mean of the most recent 4 recorded days prior to randomization; at least 8 days of records are required within the 14 days prior to a post-baseline visit. The Week 24 assessment is a prespecified key secondary endpoint. |
| Secondary | Change From Baseline in Loss of Smell (Hyposmia/Anosmia) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60 | Participants daily assess the severity of loss of smell for the previous day. This score is identical to the smell item in the Total Symptom Score (TSS), ranging from 0-3, where higher scores indicate more severe symptoms. Baseline is the mean of the week prior to randomization, and post-baseline is the mean of the two weeks prior to the visit. If fewer than 4 days are recorded within the 7 days prior to randomization, baseline is the mean of the most recent 4 recorded days prior to randomization; at least 8 days of records are required within the 14 days prior to a post-baseline visit. The Week 24 assessment is a prespecified key secondary endpoint. |
| Secondary | Change From Baseline in University of Pennsylvania Smell Identification Test (UPSIT) Score | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60 | A 40-item odor identification test, the University of Pennsylvania Smell Identification Test (UPSIT) awards 1 point for each correctly identified odor, with a total score ranging from 0 to 40, where higher scores indicate better olfactory function. The Week 24 assessment is a prespecified key secondary endpoint. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT07903194
GET https://conductscience.org/api/trials/v1/NCT07903194/registered