This page separates reported trial results from statistical interpretation. Numerical efficacy and safety results are taken from the ClinicalTrials.gov record. The registry reports that the study was terminated early following a futility analysis concluding that zinpentraxin alfa was unlikely to meet its primary endpoint.
1. Trial at a Glance
STARSCAPE was a randomized, double-blind, parallel-group phase 3 trial evaluating zinpentraxin alfa versus placebo in participants with idiopathic pulmonary fibrosis. The registry reports an enrollment of 665 participants, 1 registered primary endpoint, 16 posted outcome measures, and 4 posted statistical analyses.
| Feature | STARSCAPE |
|---|---|
| Trial | STARSCAPE |
| NCT ID | NCT04552899 |
| Phase | Phase 3 |
| Condition | Idiopathic Pulmonary Fibrosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Primary purpose | Treatment |
| Enrollment | 665 |
| Interventions | PRM-151 (Zinpentraxin Alfa) and placebo |
| Trial status | Terminated |
| Start | 2021-03-19 |
| Primary completion | 2023-02-10 |
| Lead sponsor | Hoffmann-La Roche |
| Sponsor type | Industry |
2. Clinical Question
The primary clinical question was whether zinpentraxin alfa could produce a different change in forced vital capacity compared with placebo from baseline up to Week 52 in participants with idiopathic pulmonary fibrosis.
Population
Participants with idiopathic pulmonary fibrosis enrolled in the phase 3 STARSCAPE trial.
Intervention
PRM-151 (zinpentraxin alfa).
Comparator
Placebo.
Primary question
Does zinpentraxin alfa produce a different absolute change in FVC from baseline through Week 52 compared with placebo?
3. Trial Design
Zinpentraxin Alfa
- PRM-151 (zinpentraxin alfa)
- Compared with placebo in the randomized parallel-group design
Placebo
- Placebo drug
- Served as the randomized comparison group
4. Trial Timing and Status
Study start
The registry lists March 19, 2021 as the study start date.
Primary completion
The registry lists February 10, 2023 as the primary completion date.
Early termination
The study was terminated early following a futility analysis. The registry states that the futility analysis concluded that zinpentraxin alfa was unlikely to meet its primary endpoint.
5. Endpoints
| Endpoint | Registry definition / time frame | Type |
|---|---|---|
| Absolute Change in Forced Vital Capacity (FVC [mL]) | From Baseline up to Week 52 | Primary; continuous |
| Time to Disease Progression | From Baseline up to 1 year | Secondary; time-to-event |
| Time to First Respiratory-related Hospitalizations | From Baseline up to 1 year | Secondary; time-to-event |
| Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | From Baseline up to 1 year | Secondary; time-to-event |
The registry reports 16 outcome measures in total, but the ClinicalTrials.gov record contains formal numerical analyses for 1 primary endpoint and 3 secondary endpoints. The remaining posted outcome measures are therefore not described numerically here.
6. Statistical Methodology
Primary endpoint: Random Coefficient Regression Model
The primary endpoint, absolute change in FVC from baseline up to Week 52, was analyzed using a Random Coefficient Regression Model (RCRM). The registry identifies the outcome as continuous and reports the effect measure as the difference in change from baseline between zinpentraxin alfa and placebo.
The registry reports an estimated difference of -20.83 mL, with a two-sided 95% confidence interval of -87.94 to 46.29 mL.
Time-to-event endpoints: Log-rank testing
The three registry-reported secondary analyses were time-to-event outcomes. Each used a log-rank test and reported a hazard ratio as the effect measure. The analysis population was the full analysis set described in the registry.
A hazard ratio compares estimated event rates over follow-up under the time-to-event analysis. It is not an absolute probability, a median survival time, or the proportion of participants who benefit.
Full analysis set
The registry analysis descriptions state that the full analysis set included all randomized participants who received at least one administration, either a full or partial dose, of study drug and used the grouping according to treatment assignment. The analysis text also identifies an intention-to-treat analysis concept.
7. Primary Endpoint Result: Absolute Change in FVC
The registered primary endpoint was absolute change in forced vital capacity from baseline up to Week 52. The registry provides a formal statistical analysis using a Random Coefficient Regression Model.
Difference in change from baseline
95% CI: -87.94 to 46.29 mL · P = 0.54
Comparison: zinpentraxin alfa vs placebo
| Feature | Primary FVC analysis |
|---|---|
| Endpoint | Absolute Change in Forced Vital Capacity (FVC [mL]) |
| Time frame | From Baseline up to Week 52 |
| Endpoint type | Continuous |
| Analysis method | Random Coefficient Regression Model (RCRM) |
| Effect measure | Difference in Change from Baseline |
| Estimate | -20.83 mL |
| 95% CI | -87.94 to 46.29 mL |
| P-value | 0.54 |
| Hypothesis type | Superiority |
The estimated difference in change from baseline was -20.83 mL for zinpentraxin alfa relative to placebo. Because the effect is expressed as treatment minus placebo, the negative point estimate means the estimated change was 20.83 mL lower in the zinpentraxin alfa group under the reported model.
The estimate should not be interpreted as saying that every participant lost exactly 20.83 mL, nor does it represent an individual patient's predicted FVC change. It is a model-based comparison of the groups' change from baseline.
The 95% confidence interval of -87.94 to 46.29 mL spans both negative and positive values. Thus, the reported interval is compatible with a range of group differences in either direction rather than identifying a precise treatment effect.
The P-value of 0.54 is a measure of compatibility with the statistical testing framework under the null hypothesis; it is not a measure of effect size, clinical importance, or the probability that the treatment works. The magnitude and uncertainty of the estimated difference are better represented by the estimate and confidence interval.
Because the trial was terminated early after a futility analysis, the endpoint should also be interpreted in the context of the trial's early stopping. The registry's stated reason for termination was that zinpentraxin alfa was unlikely to meet the primary endpoint.
8. Secondary Endpoint Results
Time to Disease Progression
Hazard ratio
95% CI: 0.91–1.47 · P = 0.2512
Time frame: From Baseline up to 1 year
| Feature | Reported analysis |
|---|---|
| Endpoint | Time to Disease Progression |
| Time frame | From Baseline up to 1 year |
| Analysis | Log Rank |
| Effect measure | Hazard Ratio (HR) |
| Estimate | 1.15 |
| 95% CI | 0.91–1.47 |
| P-value | 0.2512 |
| Hypothesis type | Superiority |
An HR of 1.15 means that the estimated instantaneous rate of the analyzed progression event was higher in the zinpentraxin alfa group than in the comparison group under the reported time-to-event model. It does not mean that 15% more participants progressed, nor does it mean that an individual participant had a 15% higher probability of progression.
The 95% CI of 0.91–1.47 includes 1.00, indicating substantial uncertainty about the direction and magnitude of the relative hazard. The P-value of 0.2512 is not an effect-size measure and should not be interpreted as the probability that the null hypothesis is true.
The analysis uses time-to-event methods, so censoring and the pattern of follow-up are integral to interpretation. The ClinicalTrials.gov record does not report median time to progression or a Kaplan-Meier curve, so those quantities are not presented here.
Time to First Respiratory-related Hospitalizations
Hazard ratio
95% CI: 0.51–1.97 · P = 0.9833
Time frame: From Baseline up to 1 year
| Feature | Reported analysis |
|---|---|
| Endpoint | Time to First Respiratory-related Hospitalizations |
| Time frame | From Baseline up to 1 year |
| Analysis | Log Rank |
| Effect measure | Hazard Ratio (HR) |
| Estimate | 1.01 |
| 95% CI | 0.51–1.97 |
| P-value | 0.9833 |
| Hypothesis type | Superiority |
An HR of 1.01 is very close to 1.00, so the point estimate indicates little difference in the estimated instantaneous hospitalization rate between the groups. It does not establish equivalence or prove that the two groups have identical risks.
The confidence interval is 0.51–1.97, which is wide and spans 1.00. This indicates considerable uncertainty around the estimated relative hazard. The P-value of 0.9833 does not measure the size or clinical importance of the effect.
Because this is a time-to-event endpoint, participants who do not experience a first respiratory-related hospitalization during the relevant observation period can contribute censored follow-up. The ClinicalTrials.gov record does not provide event counts, median time to hospitalization, or Kaplan-Meier estimates.
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Hazard ratio
95% CI: 0.40–1.86 · P = 0.7005
Time frame: From Baseline up to 1 year
| Feature | Reported analysis |
|---|---|
| Endpoint | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) |
| Time frame | From Baseline up to 1 year |
| Analysis | Log Rank |
| Effect measure | Hazard Ratio (HR) |
| Estimate | 0.86 |
| 95% CI | 0.40–1.86 |
| P-value | 0.7005 |
| Hypothesis type | Superiority |
An HR of 0.86 corresponds to an estimated instantaneous event rate approximately 14% lower in the zinpentraxin alfa group relative to the comparison group, if the hazard-ratio interpretation is applied directly. This is a relative model-based quantity, not a 14% reduction in the proportion of participants experiencing an acute exacerbation.
The 95% CI of 0.40–1.86 is wide and includes 1.00. The estimate therefore has substantial statistical uncertainty, and the P-value of 0.7005 should not be interpreted as a probability that the treatment has no effect.
The registry does not provide median event time, event counts, or a survival curve for this analysis in the ClinicalTrials.gov record. Those quantities therefore cannot be inferred or reconstructed from the reported hazard ratio alone.
9. Results Summary
| Endpoint | Method | Effect estimate | 95% CI | P-value |
|---|---|---|---|---|
| Absolute Change in FVC, baseline to Week 52 | Random Coefficient Regression Model | Difference in change: -20.83 mL | -87.94 to 46.29 mL | 0.54 |
| Time to Disease Progression, up to 1 year | Log-rank | HR 1.15 | 0.91–1.47 | 0.2512 |
| Time to First Respiratory-related Hospitalizations, up to 1 year | Log-rank | HR 1.01 | 0.51–1.97 | 0.9833 |
| Time to First Acute Exacerbation of IPF, up to 1 year | Log-rank | HR 0.86 | 0.40–1.86 | 0.7005 |
The ClinicalTrials.gov record therefore contain one formal primary-endpoint analysis and three formal secondary time-to-event analyses. The primary analysis reports a difference in FVC change of -20.83 mL with a 95% confidence interval extending from -87.94 to 46.29 mL. The secondary hazard-ratio estimates are 1.15, 1.01, and 0.86 for disease progression, respiratory-related hospitalization, and acute exacerbation, respectively.
10. Statistical Methods Explained
Why was a Random Coefficient Regression Model used for FVC?
FVC is a continuous measurement observed over time. A Random Coefficient Regression Model can account for repeated measurements within participants while allowing individual participants to have their own trajectory characteristics. In this trial, the registry specifically reports RCRM as the method for the primary FVC analysis.
The important distinction is between the observed repeated measurements and the estimated treatment difference in change from baseline. The reported -20.83 mL is the treatment comparison generated by the model, not a raw difference calculated from two single observations.
What does a difference in change from baseline of -20.83 mL mean?
The effect measure is defined as the difference in change from baseline between zinpentraxin alfa and placebo. A negative value means the estimated change was lower in the zinpentraxin alfa group under the reported model. Here, the estimate is -20.83 mL.
The estimate should not be converted into a percentage without additional baseline information. The ClinicalTrials.gov record does not provide the baseline FVC values needed for such a calculation.
Why does the confidence interval matter?
The 95% confidence interval for the primary difference is -87.94 to 46.29 mL. This interval describes statistical uncertainty around the estimated group difference under the analysis framework. It does not describe the range of individual participant responses.
Because the interval includes zero, the data are compatible with both a negative and a positive treatment difference within the uncertainty represented by the interval.
What does a hazard ratio of 1.15 mean?
For the time-to-disease-progression analysis, the reported HR is 1.15. In a conventional hazard-ratio interpretation, this represents an estimated instantaneous event rate 15% higher in the zinpentraxin alfa group relative to the comparator. It is not equivalent to saying that 15% more participants experienced disease progression.
Hazard ratios summarize relative event rates over time. They depend on the time-to-event framework, including censoring and the model assumptions underlying the reported effect estimate.
Why does an HR of 0.86 not mean that 14% fewer participants had an acute exacerbation?
The HR of 0.86 for time to first acute exacerbation represents a relative comparison of instantaneous event rates. A simple subtraction from 1 gives 0.14, or 14%, but that should be described as a relative hazard interpretation rather than as a 14-percentage-point reduction in the proportion of participants with an event.
An absolute risk difference would require the corresponding cumulative event probabilities or other absolute measures, which are not reported in the ClinicalTrials.gov record.
Why does the P-value not measure treatment effect size?
A P-value reflects the degree of incompatibility between the observed data and a specified null hypothesis under the statistical testing framework. It is affected by both the magnitude of the observed effect and the amount of information available.
For example, the primary P-value is 0.54, but that number does not tell us that the treatment effect is "54%" or that there is a 54% probability that the treatment is ineffective. The estimated difference and its confidence interval provide the direct quantitative description of the observed treatment comparison.
Why is early termination important for interpretation?
The registry states that the study was terminated early after a futility analysis concluded that zinpentraxin alfa was unlikely to meet its primary endpoint. Early stopping changes the amount of information accumulated and can affect the precision and interpretation of the observed treatment effect.
Most importantly, the termination statement is itself part of the documented trial record. The posted results should therefore be understood as results from a trial that ended early rather than as results from a fully completed trial with all originally planned information.
11. Intention-to-Treat and Analysis Population
The ClinicalTrials.gov record identifies the analysis population as the full analysis set. The registry description states that this set included all randomized participants who received at least one administration, full or partial, of study drug, with grouping according to treatment assignment. The analysis text also identifies intention-to-treat analysis as a concept used in the analysis.
| Population feature | Registry-supported description |
|---|---|
| Randomization | Participants were randomized. |
| Minimum treatment exposure | At least one administration, full or partial dose, of study drug. |
| Treatment grouping | According to treatment assignment. |
| Analysis concept | Intention-to-treat analysis is identified in the analysis text. |
The distinction matters because treatment assignment and treatment exposure answer different questions. An assignment-based analysis retains the randomized comparison, while requiring at least one administration introduces an exposure condition into the definition of the full analysis set.
12. Time-to-Event Analysis
Three of the four registry-reported formal statistical analyses are time-to-event analyses. Each uses a log-rank method and reports a hazard ratio.
A time-to-event analysis uses both whether an event occurred and when it occurred. Participants who have not experienced the event by the end of observed follow-up may contribute censored information rather than being treated as if an event occurred.
Log-rank testing
The log-rank test compares event-time distributions between treatment groups. It is particularly useful when participants have different lengths of follow-up and some observations are censored.
In STARSCAPE, the registry analyses use the log-rank method for time to disease progression, time to first respiratory-related hospitalization, and time to first acute exacerbation of IPF.
Hazard ratios
The reported hazard ratio provides a relative comparison of event rates. An HR below 1 favors a lower estimated event rate in the zinpentraxin alfa group; an HR above 1 favors a higher estimated event rate in that group.
| Endpoint | HR | Direction of point estimate |
|---|---|---|
| Time to Disease Progression | 1.15 | Higher estimated event rate with zinpentraxin alfa |
| Time to First Respiratory-related Hospitalizations | 1.01 | Very close to the comparator |
| Time to First Acute Exacerbation of IPF | 0.86 | Lower estimated event rate with zinpentraxin alfa |
These directions describe the point estimates only. They do not establish that the treatment effects differ from zero on an absolute scale or from a hazard ratio of 1.00 on a statistical-testing scale. The confidence intervals must be considered alongside each estimate.
13. Confidence Intervals and Precision
The four formal analyses provide confidence intervals with substantially different widths. This illustrates why the point estimate alone is insufficient for interpreting clinical-trial results.
| Endpoint | Point estimate | 95% CI | Interpretive feature |
|---|---|---|---|
| FVC change | -20.83 mL | -87.94 to 46.29 mL | Includes both negative and positive differences |
| Disease progression | HR 1.15 | 0.91–1.47 | Includes 1.00 |
| Respiratory-related hospitalization | HR 1.01 | 0.51–1.97 | Wide interval; includes 1.00 |
| Acute exacerbation of IPF | HR 0.86 | 0.40–1.86 | Wide interval; includes 1.00 |
The width of a confidence interval reflects statistical precision. The hospitalization and acute-exacerbation hazard-ratio intervals are especially broad relative to their point estimates, indicating substantial uncertainty around the estimated relative hazards.
A confidence interval that crosses the null value should not be described as proving that there is no treatment effect. It indicates that the interval includes values consistent with the null as well as values on either side of it.
14. Superiority Testing
The analyses posted on ClinicalTrials.gov identify superiority as the hypothesis type. This is important because the statistical question is whether the treatment groups differ under a superiority framework, rather than whether the treatment is merely not worse than placebo by a prespecified non-inferiority margin.
Primary endpoint
The primary FVC analysis tested a superiority hypothesis using the reported difference in change from baseline.
Secondary endpoints
The three time-to-event analyses also identify superiority as the hypothesis type and use hazard ratios as effect measures.
No non-inferiority margin is reported in the ClinicalTrials.gov record. Accordingly, no non-inferiority interpretation is made on this page.
15. Multiplicity and Multiple Endpoints
The trial registry reports 1 primary endpoint and 16 posted outcome measures, with 4 statistical analyses reported in the ClinicalTrials.gov record. The ClinicalTrials.gov record does not describe an alpha-allocation strategy or a formal multiplicity adjustment across the primary and secondary endpoints.
| Analysis role | Endpoint(s) | What the ClinicalTrials.gov record establishes |
|---|---|---|
| Primary | Absolute Change in FVC | One formal superiority analysis is posted. |
| Secondary | Time to Disease Progression | Formal log-rank analysis posted. |
| Secondary | Time to First Respiratory-related Hospitalizations | Formal log-rank analysis posted. |
| Secondary | Time to First Acute Exacerbation of IPF | Formal log-rank analysis posted. |
16. Futility and Early Stopping
The registry provides a specific reason for termination: the study was stopped early based on a futility analysis that concluded that zinpentraxin alfa was unlikely to meet its primary endpoint.
A futility assessment is a forward-looking decision tool. It is distinct from a conventional superiority test: its purpose is to determine whether continuing the trial is unlikely to produce the desired result under the information available at the interim assessment.
The ClinicalTrials.gov record does not report the futility boundary, conditional-power calculation, predictive probability, information fraction, or interim sample size. Those quantities are therefore not presented or reconstructed here.
The early termination also means that the observed estimates should not be interpreted as though the trial had necessarily accumulated the same amount of information as a fully completed study.
17. Safety Results
The ClinicalTrials.gov record reports serious adverse events by arm. The figures are presented as affected participants divided by participants at risk.
| Safety measure | Zinpentraxin Alfa | Placebo |
|---|---|---|
| Serious adverse events, affected / at risk | 46 / 331 | 40 / 329 |
Zinpentraxin Alfa
46 / 331 participants were affected by serious adverse events among those at risk in the ClinicalTrials.gov record.
Placebo
40 / 329 participants were affected by serious adverse events among those at risk in the ClinicalTrials.gov record.
These figures are reported as affected participants over participants at risk. The ClinicalTrials.gov record does not provide a formal statistical comparison, confidence interval, or P-value for serious adverse events, so none is inferred.
18. Missing Data and Censoring
The ClinicalTrials.gov record does not report a specific missing-data or imputation strategy for the primary FVC analysis. They also do not specify a detailed imputation procedure for the repeated FVC measurements used in the Random Coefficient Regression Model.
For the time-to-event endpoints, censoring is inherently part of survival analysis. Participants who have not experienced the event by the end of their observed follow-up can contribute information up to the point of censoring. The ClinicalTrials.gov record, however, do not provide enough detail to describe the exact censoring rules used for each endpoint.
19. Proportional-Hazards Considerations
The secondary analyses report hazard ratios, which are commonly interpreted as relative event-rate comparisons over time. A single hazard ratio is most straightforward to interpret when the relative hazards are reasonably stable over the relevant follow-up.
The registry-reported STARSCAPE data do not provide a proportional-hazards diagnostic, a time-varying hazard-ratio analysis, or a Kaplan-Meier curve from which the assumption could be assessed. Therefore, no conclusion about whether the proportional-hazards assumption held is made here.
These measures answer different questions. The STARSCAPE registry analyses specifically report hazard ratios for the time-to-event endpoints, so those estimates should not be converted into absolute risks without additional data.
20. What the Primary Result Does — and Does Not — Mean
The primary estimate of -20.83 mL is the reported difference in change from baseline in FVC between zinpentraxin alfa and placebo. It is a group-level model-based estimate, not an individual prediction.
The 95% CI of -87.94 to 46.29 mL quantifies uncertainty around the estimated difference under the reported statistical framework. It does not represent the range of FVC changes that individual participants experienced.
The P-value of 0.54 is a hypothesis-testing quantity. It does not mean there is a 54% probability that zinpentraxin alfa is ineffective, and it does not measure clinical importance.
The registry states that the trial was terminated after a futility analysis concluded that zinpentraxin alfa was unlikely to meet its primary endpoint. That documented design history is essential context for interpreting the posted primary result.
21. Interpreting the Secondary Hazard Ratios Together
The three secondary hazard ratios point in different directions at the level of their point estimates: 1.15 for disease progression, 1.01 for respiratory-related hospitalization, and 0.86 for acute exacerbation of IPF.
This pattern should not be compressed into a single overall conclusion. Each endpoint represents a different clinical event, and each has its own uncertainty. The confidence intervals for all three secondary hazard ratios include 1.00.
| Endpoint | HR | 95% CI | Key statistical point |
|---|---|---|---|
| Time to Disease Progression | 1.15 | 0.91–1.47 | Point estimate above 1; interval includes 1 |
| Time to First Respiratory-related Hospitalizations | 1.01 | 0.51–1.97 | Point estimate near 1; interval is wide |
| Time to First Acute Exacerbation of IPF | 0.86 | 0.40–1.86 | Point estimate below 1; interval is wide |
The correct statistical lesson is that treatment effects should be interpreted endpoint by endpoint, with the point estimate, confidence interval, testing framework, analysis population, censoring, and trial stopping history considered together.
22. Limitations
- Early termination: the study was terminated based on a futility analysis that concluded zinpentraxin alfa was unlikely to meet its primary endpoint.
- Incomplete statistical detail: the ClinicalTrials.gov record identifies RCRM for the primary analysis and log-rank testing for the secondary time-to-event analyses, but do not provide the full statistical-analysis plan.
- No detailed missing-data strategy: the ClinicalTrials.gov record does not specify the imputation or missing-data approach used for the primary FVC analysis.
- No reported proportional-hazards diagnostic: the ClinicalTrials.gov record does not provide information allowing assessment of the proportional-hazards assumption.
- No absolute time-to-event estimates reported: median event times, event counts, and Kaplan-Meier estimates are not included in the ClinicalTrials.gov record.
- No secondary multiplicity strategy reported: the data do not describe an alpha-allocation or multiplicity-adjustment procedure for the secondary endpoints.
- Full analysis set definition: the registry-reported analysis population requires at least one administration of study drug, so it should not be casually equated with a pure all-randomized ITT population.
- Limited safety detail: the ClinicalTrials.gov record contains serious adverse-event counts by arm but not a complete adverse-event profile or formal comparative safety analysis.
- Registry-level reporting: the analysis presented here is necessarily limited to the statistical information from ClinicalTrials.gov and does not reconstruct unreported analyses.
23. Why This Trial Matters Statistically
STARSCAPE is a useful teaching case because it combines a longitudinal continuous primary endpoint with multiple time-to-event secondary endpoints and an early futility termination. It illustrates why clinical-trial interpretation requires more than reading a single P-value.
| Concept | How it appears in STARSCAPE |
|---|---|
| Randomization | The trial used randomized allocation to zinpentraxin alfa or placebo. |
| Blinding | The study was double-blind. |
| Parallel-group design | The trial used a parallel design with 2 arms. |
| Continuous endpoint | Absolute change in FVC was the registered primary endpoint. |
| Repeated-measures modeling | The primary analysis used a Random Coefficient Regression Model. |
| Intention-to-treat concept | The analysis text identifies intention-to-treat analysis. |
| Time-to-event analysis | Three secondary endpoints were analyzed as time-to-event outcomes. |
| Log-rank test | Each registry-reported secondary time-to-event analysis used a log-rank method. |
| Hazard ratio | Each secondary time-to-event analysis reported an HR. |
| Confidence intervals | All four formal analyses provide 95% confidence intervals. |
| Superiority testing | The analyses posted on ClinicalTrials.gov identify superiority as the hypothesis type. |
| Futility analysis | The study was terminated early after a futility analysis. |
| Safety analysis | Serious adverse events are reported by treatment arm. |
24. A Statistical Reading of the Trial
A useful way to read STARSCAPE is to move from the estimand to the uncertainty and then to the design context.
1. Start with the endpoint
The primary endpoint is absolute change in FVC from baseline through Week 52, not survival time or an event rate.
2. Identify the model
The registry reports a Random Coefficient Regression Model for the primary continuous endpoint.
3. Read the estimate
The reported difference in change from baseline is -20.83 mL for zinpentraxin alfa versus placebo.
4. Read the interval
The 95% CI extends from -87.94 to 46.29 mL, demonstrating uncertainty around the point estimate.
5. Read the P-value
The P-value is 0.54. It is a hypothesis-testing quantity, not a measure of treatment magnitude.
6. Add trial context
The study was terminated early after a futility analysis concluded that the primary endpoint was unlikely to be met.
25. Related Tutorials
Learn more about the methods used in this trial:
26. Related Statistical Calculators
27. Sources
- ClinicalTrials.gov: STARSCAPE, NCT04552899.
- PubMed: PMID 39761005.
- PubMed: PMID 38354066.
- PubMed: PMID 36724330.
28. Record Summary
STARSCAPE provides a useful example of how different endpoint types require different statistical approaches within the same randomized clinical trial. The registered primary endpoint was absolute change in FVC from baseline up to Week 52, analyzed with a Random Coefficient Regression Model. The reported treatment difference was -20.83 mL, with a 95% CI of -87.94 to 46.29 mL and a P-value of 0.54.
The registry-reported secondary analyses used log-rank methods for three time-to-event endpoints and reported hazard ratios of 1.15 for time to disease progression, 1.01 for time to first respiratory-related hospitalization, and 0.86 for time to first acute exacerbation of IPF. Their corresponding 95% confidence intervals were 0.91–1.47, 0.51–1.97, and 0.40–1.86, respectively.
The most important design consideration is the trial's early termination. ClinicalTrials.gov states that the study was terminated based on a futility analysis concluding that zinpentraxin alfa was unlikely to meet its primary endpoint. This means that interpretation should account not only for the numerical estimates and P-values, but also for the amount of information ultimately accumulated and the statistical decision to stop the trial.
Continue with the statistical methods behind STARSCAPE
Explore the core clinical-trial and survival-analysis concepts used to interpret randomized treatment effects, confidence intervals, and time-to-event endpoints.