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 POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis (NCT05932654), a na phase 2 study. The primary outcome is Proportion of Patients Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 26.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05932654 |
| Phase | Phase 2 |
| Condition | Atopic Dermatitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Biosion, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with moderate-to-severe atopic dermatitis. The registry record does not provide further eligibility details in the information available.
Intervention
BSI-045B 300 mg by subcutaneous injection: weekly for 4 weeks, then every 2 weeks through Week 24.
Comparator
There was no comparator group. The study is recorded as single-group, with allocation listed as not applicable.
Primary question
What proportion of patients achieved at least a 75% reduction in EASI at Week 26?
The trial is described as a multicenter proof-of-concept study. Its main efficacy question concerns whether patients reached the specified EASI improvement threshold at the stated assessment time. The registry record identifies the endpoint and its intended expression as a percentage of patients, but does not report the observed percentage or its confidence interval. Therefore, the clinical question can be described, but the registry information does not establish how many patients met the endpoint.
Because the study has no control group, its primary question is about outcomes among patients treated with BSI-045B, not a direct comparison with another treatment or with no treatment. A single-group result, if reported, would describe what was observed in this study population; by itself, it would not isolate the treatment’s effect from other influences on outcomes.
3. Trial Design
The registry record describes a completed, multicenter phase 2a proof-of-concept clinical trial of BSI-045B in patients with moderate-to-severe atopic dermatitis. The study is recorded as single-group, with allocation listed as not applicable and masking listed as none. The registry lists enrollment as 22. It does not describe a randomized comparison or a control arm.
Participants in the 300 mg group were scheduled to receive BSI-045B by subcutaneous injection weekly for 4 weeks, followed by injections every 2 weeks through Week 24. The primary endpoint was assessed at Week 26. The brief summary describes the study as evaluating efficacy, safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics. The listed secondary outcomes include pharmacokinetic parameters and immunogenicity following treatment.
The registry lists the study start as 2023-07-31 and primary completion as 2024-09-18, and its status is completed. Those record details describe the study’s planned structure and administrative status; they do not show whether every planned assessment was completed or how many participants contributed data to a particular outcome. The analyzed population, participant flow, and handling of missing observations are not reported in the registry record.
With no concurrent comparator, the design can describe outcomes observed in the treated group but cannot provide a randomized estimate of the difference between BSI-045B and another treatment. The registry record does not report further details of the protocol or statistical plan.
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 | 300 mg |
|---|---|
| STARTED | 22 |
| COMPLETED | 17 |
| NOT COMPLETED | 5 |
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.
| Characteristic | Unit | 300 mg |
|---|---|---|
| Participants analysed | 22 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 22 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 43.5 (SD 14.27) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 14 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 11 |
| Race (NIH/OMB): White | Participants | 8 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| BMI | kg/m2 | 28.08 (SD 3.536) |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Patients Achieving at Least 75% Reduction in Eczema Area and Severity Index [EASI] at Week 26, measured over Week 26.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of patients achieved EASI75 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the proportion of patients achieving at least a 75% reduction in Eczema Area and Severity Index (EASI) at Week 26. EASI is described in the registry record as a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis. Its score ranges from 0 to 72, with higher scores indicating more severe and/or more extensive disease.
An EASI75 response is a threshold outcome: a patient either meets the stated reduction criterion at the assessment or does not. The endpoint then expresses the number meeting that criterion as a proportion of the assessed group. Threshold endpoints can make a clinical response easier to summarize than changes across the full range of a continuous score, but they do not show how far above or below the threshold individual outcomes fell.
The registry record specifies a 95% confidence interval as the intended measure of uncertainty for the endpoint. It does not report the observed proportion or the interval itself. Consequently, the endpoint definition explains what the study intended to measure, but no efficacy estimate can be interpreted from the registry information available.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record defines a clinically interpretable response threshold at Week 26: at least a 75% reduction in EASI. However, it does not report the number or proportion of participants meeting that threshold, nor the stated 95% confidence interval. The principal efficacy result is therefore not reported in the registry record. A reader cannot use the endpoint definition alone to judge the observed response rate or its precision.
The registry lists enrollment as 22. This is a study enrollment figure, not a reported denominator for the Week 26 endpoint. The number assessed at that visit, the number included in the primary analysis, and the treatment of participants with missing data are not reported in the registry record. It would be inappropriate to treat the enrollment figure as the endpoint denominator without that information.
The single-group, unmasked design is important for interpretation. Any reported outcome in such a design would describe the treated group, but there is no randomized control group to provide a like-for-like estimate of what would have happened under another condition. Changes over time cannot be attributed solely to the intervention from this design. The registry record does not report a comparative efficacy analysis.
The safety information is also limited to summary counts. In the 300 mg group, 22 participants are listed as at risk for serious adverse events, none as affected by a serious adverse event, and 22 as at risk for other adverse events, with 5 affected. Deaths are listed as 0. The record does not provide event terms for serious events, and it does not give the detailed event descriptions, timing, severity, or relatedness needed for a fuller safety interpretation.
These record entries should be read as a limited account of the registered results rather than a complete assessment of efficacy or safety. The absence of a reported primary result does not mean that the endpoint was not measured or that no responses occurred; it means the result is not reported in the registry record. The completion status likewise does not substitute for outcome data.
9. Statistical Methods Explained
Statistical interpretation depends on separating an endpoint’s definition from its estimate. The registry defines the primary endpoint as the proportion achieving EASI75 at Week 26, but does not report the observed proportion. Without that estimate, there is no efficacy value to interpret and no basis for describing the result as high, low, or different from another group. The same applies to the specified 95% confidence interval: its role can be explained, but its actual limits are not reported in the registry record.
What would a confidence interval communicate?
In general, a confidence interval describes the statistical uncertainty around an estimated quantity under the assumptions of the method used. For a proportion, it gives a range of values compatible with the data and method, rather than a guarantee that the true value lies in that particular interval. Wider intervals indicate less precision, while narrower intervals indicate greater precision. The interval cannot be assessed in this case because neither its limits nor the observed proportion are reported.
Why does the single-group design matter?
In general, a control group provides a reference for interpreting outcomes in the intervention group. Random allocation can help make those groups comparable, on average, with respect to both measured and unmeasured factors. Here, the registry records a single-group study and no comparator. The results, if available, could describe outcomes among participants receiving BSI-045B, but could not directly estimate a randomized contrast with another treatment or control condition. The registry lists masking as none; it does not report additional measures intended to limit assessment or reporting influences.
The endpoint is a binary threshold outcome: each assessed participant either meets the EASI75 criterion or does not. In general, analyzing a threshold can simplify communication, but it also discards information about the degree of change within each category. A participant just below the threshold and one with little change are both counted as not meeting it, while participants with different amounts of improvement above the threshold are counted as meeting it. No continuous EASI results are reported in the registry record.
What can the enrollment figure tell us?
The registry lists enrollment as 22, but that entry does not establish the denominator used for the primary endpoint. Enrollment, treatment exposure, follow-up completion, and inclusion in an endpoint analysis can differ. In general, the denominator and analysis population should be stated alongside a proportion so readers can understand which observations contributed. Those details are not reported in the registry record.
The record identifies the primary endpoint’s intended uncertainty measure as a 95% confidence interval, but does not report the method used to calculate it. The statistical analysis plan, including the exact estimator and any adjustments, is not reported in the registry record. Without those details, it is not possible to evaluate whether the interval method was appropriate for the analysis or to reproduce the estimate.
How should planning illustrations be understood?
In general, sample-size planning uses assumptions about the outcome, the effect of interest, the significance level, allocation, and statistical method. Such planning figures are not observed outcomes and do not show the precision actually achieved. The registry describes planning assumptions involving a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as a fraction of an observed effect. Those assumptions do not describe this single-group trial’s registered design, and no trial-specific sample-size justification or planning calculation is reported in the registry record. Any planning illustration should therefore be kept separate from evidence about the study’s observed outcomes.
The registry reports no analysis entries. That limits what can be learned about the analyses actually performed, including any adjusted analyses or sensitivity analyses. The methods used for handling missing data, defining analysis populations, and assessing robustness are not reported in the registry record. These omissions do not prove that such methods were absent from study documents; they mean those details cannot be evaluated from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 10 outcome measures, but does not report how the primary endpoint was prioritized in the analysis, whether other outcomes were treated as confirmatory or exploratory, or whether any adjustment for multiple testing was planned or applied. When many endpoints or comparisons are examined, the chance of at least one apparently unusual result can increase. In general, multiplicity methods can help address that issue, but the appropriate approach depends on the prespecified questions and analysis plan. Those details are not reported in the registry record.
The record also lists no analysis entries. It therefore does not provide results or analysis details for the listed secondary outcomes, including the pharmacokinetic and immunogenicity outcomes. No interim analysis information or statistical analysis plan is reported in the registry record.
Missing-data handling is not reported in the registry record. It does not state how participants without a Week 26 assessment were handled, whether any imputation was used, or whether sensitivity analyses were conducted. The enrollment figure of 22 does not establish the number with an observed primary endpoint. The endpoint denominator and the analysis population are not reported.
These gaps affect the interpretation of a proportion because the estimate depends on which participants and observations are included. In general, an analysis limited to participants with observed assessments may differ from an approach that makes assumptions about missing outcomes. Without the analysis population and missing-data methods, the extent and direction of any such influence cannot be assessed.
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 |
|---|---|---|---|
| 300 mg | 0 | 22 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 300 mg | 0 of 22 |
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 |
|---|---|
| 300 mg | 5 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 300 mg |
|---|---|---|
| headache | Nervous system disorders | 5 of 22 |
For the 300 mg group, the registry record lists 22 participants at risk for serious adverse events and 0 affected. It lists 22 at risk for other adverse events and 5 affected. Deaths are listed as 0. These are counts, not rates calculated for comparison with another group; the study has no comparator group.
The record does not provide serious adverse-event terms, so the types of serious events cannot be described from this information. It also does not provide a detailed breakdown of the other adverse events or information on severity, timing, duration, or relationship to treatment. The observation period and the rules used to classify events are not reported in the registry record.
A count of 0 serious adverse events in the registry entry should be read as a reported count for this group, not as proof that serious risks are absent. The record does not support comparison with another treatment or broader conclusions about safety. It also does not show whether all participants had equivalent follow-up or contributed to all safety assessments.
12. What the Result Does, and Does Not, Mean
The registry record establishes the study question, design, dosing schedule, and selected safety counts. It does not report the primary efficacy estimate. In particular, the proportion achieving EASI75 at Week 26 and its specified 95% confidence interval are not reported in the registry record. The main efficacy result therefore cannot be interpreted from the information available.
Even if a single-group response estimate were available, it would describe the outcomes observed among the treated participants rather than the effect of BSI-045B relative to a control. Without a comparator, there is no randomized basis for separating treatment effects from other explanations for change over time. The unmasked design is another consideration when interpreting assessments and reports, although the registry record does not provide details about the measurement process.
The safety counts offer a narrow description: the registry lists no serious adverse events and no deaths in the stated categories, and lists 5 participants affected by other adverse events. Those counts do not establish the nature or severity of the events, and they cannot quantify comparative risk. The record does not report enough detail to assess the full safety profile.
The completed status indicates the registry’s study status, not that every result or analysis is reported. Missing outcome estimates should not be interpreted as evidence of either benefit or lack of benefit. The appropriate conclusion is limited: the trial was designed to assess a specified Week 26 response and other outcomes, while the registry record does not report the primary response result or key analysis details needed to evaluate it.
13. Why This Trial Matters Statistically
This study is statistically notable because its registry record poses a clear threshold-based efficacy question but does not report the estimate needed to answer it. Defining an endpoint in advance is important: it clarifies what outcome was intended and when it was assessed. But a definition alone is not a result. Without the Week 26 EASI75 proportion and its confidence interval, readers cannot assess either the observed response frequency or its precision.
The single-group design also illustrates the distinction between describing outcomes and estimating comparative effects. A treated-group outcome can be informative as a description of the participants observed, but it is not a randomized comparison. The design does not provide a control group against which to quantify a treatment contrast.
The record’s limitations are relevant beyond the primary endpoint. It lists secondary outcome categories and safety counts, but does not provide analysis details, participant-level flow, the Week 26 endpoint denominator, or missing-data methods. Such information is important for understanding what evidence supports a reported estimate and how broadly it can be interpreted.
For statistical readers, the central lesson is to distinguish what the registry specifies from what it reports. The endpoint, schedule, and design are specified; the primary efficacy result is not reported in the registry record. This distinction prevents an outcome definition, study completion status, or enrollment figure from being mistaken for evidence about the observed treatment response.
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 main trial-specific limitation in interpreting efficacy is that the registry record does not report the primary endpoint result or its 95% confidence interval. Although the outcome is defined at Week 26, the observed proportion, its denominator, and the analysis population are not reported. The record therefore does not allow assessment of the estimate or its precision.
The single-group design has no comparator, and masking is listed as none. Consequently, any outcomes reported for the group would not provide a randomized comparison. The registry record does not report further details about outcome assessment that might help readers evaluate possible assessment influences.
The registry lists enrollment as 22, but does not report participant flow, treatment completion, the number assessed at Week 26, or reasons for missing assessments. The statistical analysis plan, missing-data approach, and any sensitivity analyses are not reported in the registry record. The presence or absence of these details in other study documents cannot be inferred.
Safety reporting is also limited. The record gives summary counts but does not provide event terms for serious adverse events, detailed descriptions of other events, or information about event timing, severity, or relatedness. It does not report the observation period or explain the classification rules. These constraints prevent a detailed assessment of safety patterns.
Finally, the registry record lists no analysis entries. This limits evaluation of how the registered outcomes were analyzed and whether any multiplicity procedures or additional analyses were used. These are limitations of the available registry information, not proof that the study team did not conduct further analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis — NCT05932654.
- Registry record last updated 2025-10-15; status last verified 2025-09.
- Results first posted 2025-10-15.
- 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
The registry describes a completed, multicenter phase 2a proof-of-concept study of BSI-045B in moderate-to-severe atopic dermatitis. It lists enrollment as 22 and records a single-group, unmasked design with no comparator. The intervention was BSI-045B 300 mg by subcutaneous injection weekly for 4 weeks, then every 2 weeks through Week 24.
The primary endpoint was the proportion achieving at least a 75% reduction in EASI at Week 26, with a 95% confidence interval specified. The observed endpoint result and interval are not reported in the registry record. The safety entry lists 0 serious adverse events, 5 participants affected by other adverse events, and 0 deaths in the 300 mg group. Further outcome and analysis details, including the endpoint denominator and missing-data methods, are not reported in the registry record.