This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis (NCT05090904), a randomized phase 2 study. The primary outcome is Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05090904 |
| Phase | Phase 2 |
| Condition | Cystic Fibrosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 29 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Insmed Incorporated |
| Results posted | Yes |
2. Clinical Question
Population
Adults with cystic fibrosis. The registry record lists 29 participants enrolled. The primary pharmacokinetic analysis set is defined as randomized participants who received at least one dose of brensocatib and had enough data to calculate at least one pharmacokinetic parameter. The posted primary outcome includes eight participants in each brensocatib dose group; the placebo group is not included in that outcome.
Intervention
Brensocatib tablets taken orally once per day for 28 days. The study included dose groups of 10 mg, 25 mg, and 40 mg. The primary outcome described in the registry record concerns the maximum plasma concentration of brensocatib after the first day’s administration.
Comparator
A matching placebo taken once per day for 28 days. The safety results include a placebo group of five participants. The posted primary pharmacokinetic outcome reports values for the brensocatib dose groups, not a brensocatib-versus-placebo estimate.
Primary question
What was the maximum plasma concentration of brensocatib on Day 1 in the three dose groups, and what safety events were recorded during the study? The primary endpoint is descriptive: the registry reports group geometric means and geometric coefficients of variation, without a posted treatment comparison or confidence interval for these values.
3. Trial Design
The registry record describes a Phase 2a, randomized, parallel-group, placebo-controlled study in adults with cystic fibrosis. Participants were assigned to brensocatib at 10 mg, 25 mg, or 40 mg once per day, or to matching placebo once per day. Each assigned treatment was taken for 28 days. The record lists 29 participants enrolled, with eight participants in each brensocatib group and five in the placebo group in the posted safety results.
The official title calls the study single-blind, while the registry’s masking description identifies it as double-masked. These descriptions are inconsistent within the registry record, and further details resolving the discrepancy are not reported in the registry record. Random allocation and a parallel-group structure are recorded. The randomization method, allocation concealment procedures, and further details of masking are not reported in the registry record.
The stated main objectives were to evaluate brensocatib pharmacokinetics after once-daily oral administration and to evaluate safety compared with placebo during the 4-week treatment period. The primary outcome is maximum plasma concentration on Day 1. Secondary outcomes cover dose proportionality for maximum concentration and area-under-the-curve measures, along with AUClast, on Days 1 and 28. The registry lists four secondary outcomes and 12 outcome measures overall. It lists no posted analyses. The protocol, detailed analysis plan, and sample-size justification are not reported in the registry record.
The study is marked completed. Its start date is 2021-11-30, and its primary completion date is 2022-11-01. These record details describe the planned design and status; they do not themselves establish the completeness of follow-up or the clinical importance of any outcome.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Brensocatib 10 mg | Brensocatib 25 mg | Brensocatib 40 mg | Placebo |
|---|---|---|---|---|
| STARTED | 8 | 8 | 8 | 5 |
| COMPLETED | 8 | 8 | 8 | 5 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Pharmacokinetic (PK) Analysis Set included all randomized participants who received at least 1 dose of brensocatib (actual treatment) and had sufficient data to calculate at least 1 PK parameter.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.
| Characteristic | Unit | Brensocatib 10 mg | Brensocatib 25 mg | Brensocatib 40 mg | Placebo | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 8 | 8 | 8 | 5 | 29 | |
| Age, Continuous | Years | 38.3 (SD 14.86) | 42.9 (SD 16.54) | 34.6 (SD 15.95) | 34.6 (SD 9.79) | 37.9 (SD 14.59) |
| Sex: Female, Male: Female | Participants | 2 | 5 | 2 | 2 | 11 |
| Sex: Female, Male: Male | Participants | 6 | 3 | 6 | 3 | 18 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 1 | 1 | 1 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 7 | 7 | 7 | 4 | 25 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 7 | 8 | 6 | 5 | 26 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 0 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Plasma Concentration (Cmax) of Brensocatib on Day 1, measured over Predose and 0.5, 1, 2, 4, 6, 8, and 24 hours postdose on Day 1.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | nanograms per milliliter (ng/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is maximum plasma concentration, abbreviated Cmax, of brensocatib on Day 1. The stated unit is nanograms per milliliter. Measurements were scheduled predose and 0.5, 1, 2, 4, 6, 8, and 24 hours after dosing on Day 1. Cmax is a pharmacokinetic measure of the highest plasma concentration observed over the sampling period. In general, this kind of measure helps describe peak drug exposure after administration; it is not itself a measure of a clinical health outcome.
The registry reports the endpoint as a geometric mean with a geometric coefficient of variation (CV) for each brensocatib dose group. The geometric mean is a summary suited to positive measurements that may be distributed asymmetrically. The geometric CV describes relative spread around that summary, rather than the range of individual measurements or uncertainty in the group mean. For 10 mg, the geometric mean was 62.4 ng/mL and the geometric CV was 41.3%; for 25 mg, 136.0 ng/mL and 25.9%; and for 40 mg, 338.0 ng/mL and 17.7%.
The endpoint is reported for the pharmacokinetic analysis set, defined in the registry as randomized participants who received at least one dose of brensocatib and had sufficient data to calculate at least one pharmacokinetic parameter. The placebo group does not have a posted Cmax value in this outcome. No confidence intervals, individual-level distributions, or inferential comparison for this primary endpoint are reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted Day 1 Cmax summaries show higher geometric mean plasma concentrations across the brensocatib dose groups: 62.4 ng/mL for 10 mg, 136.0 ng/mL for 25 mg, and 338.0 ng/mL for 40 mg. This is a descriptive pattern in the reported group summaries. The registry does not post a statistical test or an estimated contrast between dose groups, so the values alone do not establish the statistical precision of the differences between groups.
The geometric CVs were 41.3% for 10 mg, 25.9% for 25 mg, and 17.7% for 40 mg. These values describe relative variability in the observed concentration measurements within each group under the reported summary method. They are not confidence intervals, and they do not show how precisely each group mean is estimated. Without confidence intervals or another uncertainty measure for the endpoint summaries, the precision of the group estimates cannot be assessed from the posted result alone.
The primary outcome is pharmacokinetic, not a comparison of clinical outcomes. It summarizes concentration after dosing and does not by itself show whether participants experienced a clinical benefit or harm. The registry’s listed secondary outcomes include dose proportionality measures for Cmax and area-under-the-curve quantities on Days 1 and 28. Those outcome labels describe questions the study set out to assess, but detailed results for these measures are not included in the registry record for the posted primary outcome. Their estimates and inferential conclusions are not reported in the registry record.
The safety summaries show one participant affected by a serious adverse event in the 40 mg group, with none reported in the other groups; deaths are recorded as zero in every group. The serious-event term listed is “Infective pulmonary exacerbation of cystic fibrosis,” at 12.5%. The small group sizes mean that these counts offer a limited description of events observed in this study. They cannot by themselves characterize the frequency of uncommon harms in a broader population, and they do not establish that any event was caused by study treatment.
The record reports other adverse events affecting four participants in the 10 mg group, five in the 25 mg group, four in the 40 mg group, and two in the placebo group. These are group-level counts, not a full account of event types, timing, severity, or causal attribution. The posted results therefore provide a basic description of observed events but not enough detail to make a comprehensive comparative safety assessment.
Overall, the registry results are best read as descriptive pharmacokinetic and safety information from a short study with small treatment groups. No inferential analysis of the primary endpoint, confidence interval, or analysis plan is posted. The findings describe the reported participants and do not establish the size or precision of a treatment effect on a clinical outcome.
9. Statistical Methods Explained
What does the geometric mean summarize?
In general, the arithmetic mean summarizes values by adding them and dividing by the number of observations. Pharmacokinetic measurements are positive and may be skewed, with some observations substantially larger than others. A geometric mean summarizes such measurements on a multiplicative scale and is often used for concentration data. It can be understood as a central value after working on a logarithmic scale and then returning to the original scale.
The registry reports geometric means of 62.4 ng/mL, 136.0 ng/mL, and 338.0 ng/mL for the 10 mg, 25 mg, and 40 mg groups, respectively. These are summaries of the measured concentrations in the pharmacokinetic analysis set. They are not estimates of a clinical response, and the record does not report an adjusted comparison of these group summaries.
How should the geometric coefficient of variation be read?
In general, a coefficient of variation expresses variability relative to a measure of central tendency. A geometric CV is a relative-spread summary used with geometric-scale analyses. It helps describe how dispersed measurements are around the group’s concentration profile, but it is not the same as a standard deviation, the full observed range, or a confidence interval for the geometric mean.
The posted geometric CVs are 41.3% for 10 mg, 25.9% for 25 mg, and 17.7% for 40 mg. Those values describe within-group variability as summarized by the registry. They do not indicate whether the differences among group means are statistically distinguishable. To assess uncertainty in a group estimate or a contrast, confidence intervals or other inferential results would be useful; these are not reported in the registry record.
What would a confidence interval add?
In general, a confidence interval gives a range of values compatible with an estimate under a specified statistical procedure. It conveys sampling uncertainty and is distinct from a measure of variation among participants. A confidence interval for each group mean could indicate the precision of those means, while an interval for a contrast could address the uncertainty in the difference between groups. Neither type is included with the posted primary outcome. Without them, readers should not treat the geometric means as if they were exact or use the geometric CVs as substitutes for uncertainty intervals.
What does the design allow the endpoint to address?
Randomization is intended to support comparable groups at the start of a trial, while a parallel-group design assigns each participant to an allocated group rather than having each participant receive every treatment. In general, a placebo group can help distinguish observations associated with active treatment from those occurring under the study’s comparison condition. Here, however, the posted primary Cmax outcome is reported for the three brensocatib groups only. It does not include a placebo Cmax estimate or a formal comparison with placebo.
The group sizes reported for the primary outcome are eight participants per brensocatib dose group. The registry defines the pharmacokinetic analysis set as randomized participants who received at least one brensocatib dose and had enough data for at least one pharmacokinetic parameter. The record does not give a separate account of exclusions from this set, missing concentration measurements, or the handling of incomplete sampling. Those details are not reported in the registry record.
How does dose proportionality differ from a dose-group summary?
In general, dose proportionality asks whether exposure changes in proportion to the administered dose. It is a relationship across dose levels, rather than simply a statement that the group means differ. The registry lists dose-proportionality outcomes for Cmax and AUC0-24 on Days 1 and 28, and for AUClast on Days 1 and 28. The outcome names indicate that proportionality was of interest, but the estimates, model specifications, and inferential results for these assessments are not reported in the registry record.
The primary Cmax summaries alone cannot establish dose proportionality. A formal assessment would depend on the planned method, the exposure measures, and uncertainty around the relationship across doses. The detailed statistical approach is not reported in the registry record. No assumptions about a model or a decision criterion can therefore be made from the outcome names alone.
What do the planning assumptions mean?
In general, a sample-size planning calculation estimates how many participants might be needed for a specified statistical objective under stated assumptions. The registry’s planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it also describes planning for a stated fraction of an observed effect. Such calculations are illustrations, not observed trial results and not evidence that the study had a particular probability of detecting an effect. The sample-size justification used to design this trial is not reported in the registry record.
The planning assumptions describe a two-arm comparison, while the study enrolled participants across three brensocatib dose groups and a placebo group. Consequently, an illustrative two-arm calculation should not be confused with the allocation actually used in the study or with a formal power analysis for the complete design. The reported enrollment is 29. The registry does not report an inferential analysis of the primary endpoint or enough statistical detail to determine how the planned sample size related to that endpoint.
In general, power is a property of a planned analysis under specified assumptions; it is not a result observed after a study. A recalculation based on an observed effect, if displayed elsewhere in the statistical material, would be a planning illustration rather than observed power. The sponsor’s analysis would take precedence if a discrepancy were identified. The registry record does not post an analysis of the primary endpoint to compare with such an illustration.
10. Multiplicity, Missing Data and Analysis Populations
The study lists a primary pharmacokinetic outcome and four secondary outcomes. Those secondary outcomes cover dose proportionality for Cmax and AUC measures and AUClast measures on Days 1 and 28. Considering multiple outcomes can increase the chance of obtaining at least one apparently notable result by chance if each is tested separately. In general, a prespecified multiplicity strategy may control that issue, for example by defining a testing sequence or adjusting interpretation across tests. The multiplicity strategy, if any, is not reported in the registry record.
The record lists 12 outcome measures but no posted analyses. It does not provide p-values, confidence intervals, a hierarchy of hypotheses, or a statistical analysis plan in the registry record for these results. Therefore, the statistical significance of the primary endpoint and the secondary outcomes cannot be evaluated from the posted summaries. The stated endpoints should not be read as evidence that every planned analysis produced a conclusive result.
The pharmacokinetic analysis set is described as randomized participants who received at least one dose of brensocatib and had sufficient data to calculate at least one pharmacokinetic parameter. A complete account of participant flow, missing data, exclusions, or analysis populations for the safety outcomes is not reported in the registry record. The registry also does not report how missing concentration samples or incomplete profiles were handled.
In general, missing observations can affect estimates when their absence is related to participant characteristics, treatment, or outcome values. The direction and size of any such influence depend on the missingness pattern and analysis method. Since those details are not reported, the extent to which missing data could affect these results cannot be determined from the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Brensocatib 10 mg | 0 | 8 | 0.0% |
| Brensocatib 25 mg | 0 | 8 | 0.0% |
| Brensocatib 40 mg | 1 | 8 | 12.5% |
| Placebo | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Brensocatib 10 mg | 0 of 8 |
| Brensocatib 25 mg | 0 of 8 |
| Brensocatib 40 mg | 0 of 8 |
| Placebo | 0 of 5 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Brensocatib 10 mg | 4 of 8 |
| Brensocatib 25 mg | 5 of 8 |
| Brensocatib 40 mg | 4 of 8 |
| Placebo | 2 of 5 |
Most frequent serious adverse event terms
| Event term | Organ system | Brensocatib 10 mg | Brensocatib 25 mg | Brensocatib 40 mg | Placebo |
|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | 0 of 8 | 0 of 8 | 1 of 8 | 0 of 5 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Brensocatib 10 mg | Brensocatib 25 mg | Brensocatib 40 mg | Placebo |
|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | 2 of 8 | 0 of 8 | 1 of 8 | 0 of 5 |
| Headache | Nervous system disorders | 0 of 8 | 2 of 8 | 0 of 8 | 1 of 5 |
| COVID-19 | Infections and infestations | 0 of 8 | 1 of 8 | 1 of 8 | 0 of 5 |
| Abdominal pain | Gastrointestinal disorders | 0 of 8 | 0 of 8 | 1 of 8 | 1 of 5 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 8 | 1 of 8 | 0 of 8 | 0 of 5 |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | 2 of 8 | 0 of 8 | 0 of 8 | 0 of 5 |
| Lymphadenopathy | Blood and lymphatic system disorders | 0 of 8 | 1 of 8 | 0 of 8 | 0 of 5 |
| Abdominal pain upper | Gastrointestinal disorders | 0 of 8 | 0 of 8 | 0 of 8 | 1 of 5 |
| Gastric fistula | Gastrointestinal disorders | 1 of 8 | 0 of 8 | 0 of 8 | 0 of 5 |
| Toothache | Gastrointestinal disorders | 1 of 8 | 0 of 8 | 0 of 8 | 0 of 5 |
Serious events with the highest arm-level rate: infective pulmonary exacerbation of cystic fibrosis (12.5%).
The safety results report serious adverse events by treatment group. No serious adverse events are recorded for the 10 mg group, the 25 mg group, or placebo. One participant in the 40 mg group is recorded as affected by a serious adverse event; the listed term is “Infective pulmonary exacerbation of cystic fibrosis,” with a reported value of 12.5%. Deaths are recorded as zero for every group.
The relevant group sizes are eight participants for each brensocatib dose and five for placebo. With groups of this size, a count describes what was recorded among the participants in this study; it does not give a precise estimate of event frequency outside the trial. The reported percentage is a registry value and should not be treated as an estimate of a stable underlying rate.
A serious adverse event is not automatically an event caused by the study treatment. Causal attribution, event timing, and further details are not reported in the registry record. The posted information also does not provide a complete event-by-event account or comparative statistical analysis. No deaths were reported, but that observation does not establish the absence of risk. The figures are a descriptive safety summary for the groups and treatment period recorded.
12. What the Result Does, and Does Not, Mean
The posted results establish that the registry reports Day 1 Cmax geometric means of 62.4 ng/mL, 136.0 ng/mL, and 338.0 ng/mL in the 10 mg, 25 mg, and 40 mg brensocatib groups. They also report geometric CVs of 41.3%, 25.9%, and 17.7%, respectively. These measurements describe plasma concentration and variability within the pharmacokinetic analysis set. They are not measures of clinical improvement, and the registry does not report a formal statistical comparison among the dose groups.
The outcome is relevant to characterizing brensocatib exposure after administration. It does not by itself determine how exposure relates to clinical outcomes or safety. The listed secondary outcomes indicate that the study also addressed exposure over time and dose proportionality, but detailed results for those assessments are not reported in the registry record.
The safety summaries report one serious adverse event in the 40 mg group and none in the other groups, with zero deaths in every group. Other adverse events affected four participants in the 10 mg group, five in the 25 mg group, four in the 40 mg group, and two in placebo. These counts describe events recorded during this study; they do not establish whether treatment caused an event or provide a precise estimate of risk beyond the enrolled participants.
The study’s randomized, placebo-controlled design is relevant to its stated objectives, but the registry’s posted primary outcome is not a treatment-versus-placebo contrast. The small group sizes, short treatment period of 28 days, and absence of posted inferential analyses limit what can be concluded from the summaries. The record does not provide enough information to assess confidence intervals, statistical significance, or the handling of missing pharmacokinetic data.
Accordingly, the results should be understood as descriptive observations about pharmacokinetic measurements and adverse events in this completed study. They do not demonstrate a clinical treatment effect, establish the absence of harm, or provide a definitive comparative assessment. Further details, including analysis methods and results for the listed secondary outcomes, are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative because its primary question concerns pharmacokinetic exposure rather than a clinical efficacy outcome. Cmax provides a direct summary of peak plasma concentration after dosing, and the reported geometric means describe exposure at three brensocatib dose levels. The endpoint makes clear why a study may produce useful quantitative information even when it does not report a clinical treatment comparison.
The design also raises practical interpretation questions. The study has three active dose groups and a placebo group, but the primary outcome reports Cmax only for brensocatib. The registry’s planning assumptions describe a two-arm illustration, which is not the same as the four-group structure used in the trial. Recognizing that distinction helps avoid treating an illustrative sample-size calculation as a design justification or as evidence of the trial’s observed ability to detect an effect.
The endpoint uses geometric means and geometric CVs, making it an example of how pharmacokinetic summaries can differ from ordinary arithmetic summaries. The CVs describe relative variability, not uncertainty about the means. The absence of confidence intervals and inferential comparisons is therefore important: readers can describe the observed group summaries but cannot assess precision or statistical evidence for differences from the posted primary result.
The safety counts likewise illustrate the limits of small-group summaries. The record documents events and deaths by group, but the counts do not establish causality or precisely characterize event frequency beyond the study. Together, the pharmacokinetic and safety results show why design, endpoint definition, analysis population, and uncertainty measures all matter when interpreting a clinical trial record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The posted primary endpoint is limited to Cmax on Day 1. Although the registry lists later pharmacokinetic outcomes, the detailed results for those outcomes are not included in the registry record. The available primary result therefore cannot characterize exposure over the full 28-day treatment period or establish whether the listed dose-proportionality assessments supported a particular conclusion.
The primary outcome is reported for the brensocatib groups, without a placebo value or a formal comparison between active treatment and placebo. Group geometric means and CVs are descriptive summaries; confidence intervals, p-values, and analysis details are not reported in the registry record. The precision and inferential strength of the primary result consequently cannot be evaluated from these summaries.
The endpoint’s analysis population requires receipt of brensocatib and sufficient data for at least one pharmacokinetic parameter. Participant flow and the handling of missing measurements are not reported in the registry record. The record also does not provide enough detail to assess exclusions, adherence, or the extent of any incomplete sampling.
Safety results come from small groups and a treatment period of 28 days. The registry reports counts of participants affected and a serious-event term, but further details about event timing, severity beyond the serious classification, relatedness, and treatment discontinuation are not reported in the registry record. Small groups cannot provide a precise account of uncommon events.
There is also an internal discrepancy in the masking descriptions: the official title calls the study single-blind, while the masking description identifies it as double-masked. The registry does not provide clarification. In addition, the protocol, sample-size justification, detailed statistical analysis plan, multiplicity approach, and posted inferential analyses are not reported in the registry record. These gaps constrain interpretation of both the design and the strength of statistical conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis — NCT05090904.
- Registry record last updated 2026-03-12; status last verified 2026-02.
- Results first posted 2026-03-12.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT05090904 is a completed Phase 2a randomized, parallel-group, placebo-controlled study of brensocatib in adults with cystic fibrosis. The registry lists 29 participants enrolled and once-daily treatment for 28 days in groups assigned to brensocatib 10 mg, 25 mg, 40 mg, or matching placebo.
The primary outcome is Day 1 maximum plasma concentration of brensocatib, reported as a geometric mean and geometric CV for the three active dose groups. The record also lists four secondary outcomes addressing dose proportionality and pharmacokinetic measures on Days 1 and 28. Safety results include serious and other adverse events and deaths by group. The posted material is descriptive; confidence intervals, inferential analyses, and a detailed statistical analysis plan are not reported in the registry record.