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 ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus (NCT04835441), a randomized phase 2 study. The primary outcome is Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04835441 |
| Phase | Phase 2 |
| Condition | Systemic Lupus Erythematosus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 76 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Alpine Immune Sciences Inc, A Subsidiary of Vertex |
| Results posted | Yes |
2. Clinical Question
Population
Adults with moderate to severe active systemic lupus erythematosus (SLE). The registry record describes a multinational phase 2 study and reports an enrollment of 76. The safety population included participants who received at least 1 dose of study drug during the treatment period.
Intervention
ALPN-101, also called acazicolcept. Participants received a weight-based dose of 3 milligrams/kilogram once every 2 weeks, up to 24 weeks.
Comparator
Placebo matched to ALPN-101, given up to 24 weeks. The study was randomized and placebo-controlled; the randomization ratio is not reported in the registry record.
Primary question
The primary outcome evaluates safety and tolerability by counting participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), from Day 1 through safety follow-up, up to 28 weeks. The record also lists disease-activity and flare outcomes, but their results are not reported in the registry record.
The clinical question is therefore about the safety experience during treatment and follow-up, not a single measure of whether SLE disease activity improved. TEAEs capture events that emerge during the study’s defined observation period, while SAEs identify the serious-event category. These are distinct safety summaries; a participant-level count does not describe how long an event lasted, how severe every event was, or whether events recurred.
The registry lists secondary outcomes addressing annualized flare rate and time to first flare by the BILAG-2004 Flare Index, achievement of lupus low disease activity state, change in SLEDAI-2K score, cumulative prednisone-equivalent dose through Day 169, and CLASI activity-score reduction among participants meeting the specified baseline score criterion. These outcomes address different aspects of SLE. The registry record does not report their numerical results in the registry record for this analysis, so no conclusion about differences in those outcomes can be drawn from the listed safety counts.
3. Trial Design
This was a phase 2, randomized, double-blind, placebo-controlled, parallel-group study of ALPN-101 (acazicolcept) in adults with moderate to severe active SLE. The registry describes the study as multinational and lists quadruple masking. The allocation method is recorded as randomized, but the randomization ratio and further details of sequence generation or concealment are not reported in the registry record.
Participants assigned to ALPN-101 received a weight-based dose of 3 milligrams/kilogram once every 2 weeks, up to 24 weeks. Participants assigned to the comparator received placebo matched to ALPN-101, up to 24 weeks. The planned treatment duration described in the arm information is separate from the primary safety observation window, which runs from Day 1 to safety follow-up, up to 28 weeks.
The registry reports an enrollment of 76, a study start date of 2021-06-22, a primary completion date of 2024-07-09, and a status of completed. Enrollment is a trial-level record and should not be treated as the number analyzed for every outcome: the primary safety population is defined as participants who received at least 1 dose during the treatment period. The arm-level safety counts are reported separately in the registry.
The study included safety, tolerability, efficacy, immunogenicity, pharmacokinetic, and pharmacodynamic objectives. The listed primary outcome is safety and tolerability assessed through counts of participants with TEAEs and SAEs. Secondary outcomes cover flares, disease activity, prednisone-equivalent dose, and skin disease activity. The registry record does not report the detailed statistical analysis plan, the method used to handle missing data, or whether interim analyses were planned. Those features cannot be inferred from the randomized and blinded design alone.
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.
Before assignment: The study was conducted in participants with active systemic lupus erythematosus (SLE) aged 18 years and older.
Overall Study
| Stage | ALPN-101 (Acazicolcept) | Placebo |
|---|---|---|
| STARTED | 38 | 38 |
| COMPLETED | 33 | 32 |
| NOT COMPLETED | 5 | 6 |
Reasons for not completing this period:
| Reason | ALPN-101 (Acazicolcept) | Placebo |
|---|---|---|
| Physician Decision | 4 | 4 |
| Other | 1 | 1 |
| Lost to Follow-up | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety set included all participants who received at least 1 dose of study drug in the treatment period.
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: All participants who received at least one dose of the study drug during the treatment period were included in the baseline analysis.
| Characteristic | Unit | ALPN-101 (Acazicolcept) | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 38 | 38 | 76 | |
| Age, Continuous | years | 48.7 (SD 11.20) | 47.8 (SD 11.08) | 48.3 (SD 11.07) |
| Sex: Female, Male: Female | Participants | 35 | 35 | 70 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 13 | 10 | 23 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 25 | 28 | 53 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 24 | 23 | 47 |
| Race/Ethnicity, Customized: Black or African American | Participants | 12 | 11 | 23 |
| Race/Ethnicity, Customized: Other Asian | Participants | 1 | 2 | 3 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: East Asian | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Other | Participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), measured over Day 1 up to Safety follow-up (up to 28 weeks).
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is described as safety and tolerability assessed by the number of participants with TEAEs and SAEs. Its observation period begins on Day 1 and continues through safety follow-up, up to 28 weeks. The safety set includes all participants who received at least 1 dose of study drug during the treatment period.
A participant count is a binary-outcome summary: for a specified event category, each person is classified according to whether they experienced an event during the defined observation period. This can provide a direct account of how many participants had an event in each treatment group. It does not, by itself, show the total number of episodes, event duration, timing, severity distribution, or whether the same participant experienced multiple events. Those details require additional event-level information.
TEAEs and SAEs answer related but different safety questions. TEAEs capture treatment-emergent events under the study’s reporting definition, whereas SAEs are the serious-event category. Reporting both can describe the breadth of events and the subset classified as serious. Counts are most interpretable alongside the population definition and observation window, because both determine who could contribute to the outcome and for how long events were monitored.
Safety outcomes are used in clinical trials to characterize events observed during exposure and follow-up. The registry record does not provide a single reduced comparison for this primary outcome; it indicates that the primary outcome has several categories or time points. It also does not report a statistical test or confidence interval for the endpoint in the registry record. The counts therefore support descriptive reading, not an unreported inferential conclusion.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety counts report 2 participants with serious adverse events among 38 at risk in the ALPN-101 group and 2 among 38 at risk in the placebo group. The registry lists 18 participants with other adverse events among 38 at risk in the ALPN-101 group and 16 among 38 at risk in the placebo group. No deaths are reported in either group. These are descriptive counts within the registry’s stated safety population and observation period.
The serious-event counts are the same across the groups in the posted record. That description should not be read as proof that the underlying risks are identical. Event counts in a trial of this size can be imprecise, and the registry record does not report confidence intervals or a statistical test for this outcome. Nor does the count reveal the timing, duration, clinical course, or relatedness of each event. The sponsor’s detailed safety assessment, if any, is not reported in the registry record.
The other-adverse-event counts differ in the posted summaries, but the record does not report an inferential comparison for them. Without a reported estimate and uncertainty interval, the counts alone cannot establish whether a difference is compatible with chance variation or how precisely any treatment-group contrast is estimated. They also do not indicate the number of events per participant. A person-level count and an event-level count are not interchangeable.
The registry lists Haemoglobin Decreased, Transient Ischaemic Attack, Mental Status Changes, and Acute Kidney Injury among the top serious terms, each reported as 2.6%. The listed percentages should be read as the registry reports them; an arm-specific breakdown for these terms is not stated in the registry record for this analysis. The listed terms do not replace the overall participant counts, and they do not show the full range of reported events.
The trial’s primary endpoint includes several categories or time points and has not been reduced to one comparison. As a result, the posted safety counts should not be recast as a single primary-effect estimate. The registry record does not report the analysis method, confidence intervals, p-values, or adjustment strategy for these outcomes. It also does not report numerical results for the listed secondary efficacy outcomes in the registry record for this analysis. Interpretation should remain limited to the observed safety counts and the explicitly listed outcome definitions.
Any sample-size illustration based on the observed effect is a planning calculation, not observed power and not evidence that a future study will reproduce the same result. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. Those assumptions do not fill gaps in the registry’s own statistical plan, which is not reported.
9. Statistical Methods Explained
The primary outcome is a count of participants who experienced safety events, so it can be understood as a binary outcome at the participant level: each participant either meets the event definition during the stated period or does not. This is different from counting every event. If a participant experiences more than one event, the participant-level count still records that person as a participant with an event; an event-level summary would require separate information. This distinction matters when interpreting the registry’s counts.
What does a confidence interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity under a specified statistical method. It helps readers judge the range of values reasonably compatible with the data and method, rather than focusing only on a point estimate. A narrow interval indicates greater precision than a wide interval, though the interval does not resolve questions about bias, outcome definitions, or generalizability. The registry record does not report confidence intervals for the primary safety counts in the registry record for this analysis.
Why distinguish descriptive counts from a comparison?
A count within each group describes what was recorded in that group. A formal comparison estimates a contrast between groups and usually requires a defined measure, an analysis method, and an account of uncertainty. The registry provides group-specific counts for serious and other adverse events, but the primary outcome is not reduced to a single comparison. No p-value or confidence interval for a primary comparison is reported in the registry record. It would therefore be inappropriate to infer a formal treatment effect from the counts alone.
The registry records the trial as randomized and masked. In general, random allocation is intended to create groups that are comparable on average, while masking can reduce the influence of expectations on care, reporting, or assessment. Neither design feature guarantees that every source of bias is eliminated. The registry’s masking designation is quadruple, but the roles of those masked are not described in the registry record for this analysis. Details of randomization implementation are also not reported in the registry record.
What is over-dispersion?
In general, over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can matter for outcomes such as event counts when a few participants have multiple events or when participants’ event experiences vary more than the model allows. A model that ignores over-dispersion may estimate uncertainty poorly. The primary outcome is a count of participants with events, rather than a reported model of repeated event counts. The registry does not report whether over-dispersion was assessed or whether any count model was used.
For binary participant outcomes, statistical methods may estimate a difference, ratio, or another contrast, depending on the prespecified plan. The measure chosen affects how results are expressed and how uncertainty is interpreted. No such primary comparison measure is reported in the registry record’s details for this analysis, so none should be assumed. The posted counts can be read directly, but they do not reveal whether an adjusted or unadjusted model was used by the sponsor.
The record lists nine outcome measures and eight analyses. Those registry totals do not, by themselves, establish how outcomes were grouped analytically, which outcome was tested first, or how multiplicity was handled. The record’s primary safety endpoint is described as having several categories or time points, and it is not reduced to one comparison. A count of listed measures is not a substitute for the analysis plan.
How should planning calculations be read?
In general, sample-size planning calculations ask how much information a future study might need to detect a chosen effect under specified assumptions. The registry’s stated illustration uses a two-sided significance level of 0.05, equal allocation between the groups, and a normal approximation. Its target effect is a stated fraction of the observed effect. These are planning assumptions, not results of a trial design justification reported by the registry.
Such calculations are sensitive to the effect chosen, the variability or event frequency assumed, the outcome definition, and the statistical test. If the observed effect is used as the reference, it should not be assumed to be a stable estimate of the effect in a future study. A planning illustration is not observed power: after a study is completed, the data and uncertainty estimates are more informative than a retrospective power calculation. The registry does not report the original sample-size justification or enough information to assess it.
When a trial has more than one outcome, multiple analyses can raise a multiplicity question. In general, testing several hypotheses can increase the chance of at least one apparently positive result if each is assessed without an appropriate strategy. Possible approaches depend on the prespecified objectives and analysis plan. The registry record does not report a multiplicity strategy for this study. No adjustment should be presumed from the number of listed analyses.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists nine outcome measures and eight analyses, including the primary safety and tolerability outcome and secondary outcomes related to flares, disease activity, steroid use, and skin activity. The record does not report a multiplicity strategy. It is therefore not possible to determine from the registry information whether hypotheses were tested in a hierarchy, whether any adjustment was applied, or which secondary comparisons were considered confirmatory. In general, multiplicity matters because examining several outcomes can increase the chance of a nominally noteworthy finding when no adjustment or prespecified testing sequence is used. That general concern does not establish that an error occurred in this trial.
The approach to missing data is not reported in the registry record. The registry entries also do not describe how participants with incomplete follow-up, unavailable outcome assessments, or treatment discontinuation were handled for each endpoint. The stated safety population includes participants who received at least 1 dose during the treatment period, but this definition alone does not specify how missing safety information was treated or how analysis populations differed across secondary outcomes.
The registry does not report whether any imputation, sensitivity analysis, or missing-data assumption was used. In general, missingness can affect interpretation if the chance of an unavailable measurement is related to a participant’s outcome or treatment experience. Readers should not infer that missing data were absent, or that a particular method was used, from the registry’s population definition.
The primary outcome has several categories or time points and is not reduced to one comparison. The registry record does not report a complete statistical plan, analysis hierarchy, or analysis population for every outcome. These gaps limit reconstruction of the sponsor’s inferential approach from the registry record alone.
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 |
|---|---|---|---|
| ALPN-101 (Acazicolcept) | 2 | 38 | 5.3% |
| Placebo | 2 | 38 | 5.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| ALPN-101 (Acazicolcept) | 0 of 38 |
| Placebo | 0 of 38 |
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 |
|---|---|
| ALPN-101 (Acazicolcept) | 18 of 38 |
| Placebo | 16 of 38 |
Most frequent serious adverse event terms
| Event term | Organ system | ALPN-101 (Acazicolcept) | Placebo |
|---|---|---|---|
| Haemoglobin Decreased | Investigations | 1 of 38 | 0 of 38 |
| Transient Ischaemic Attack | Nervous system disorders | 0 of 38 | 1 of 38 |
| Mental Status Changes | Psychiatric disorders | 1 of 38 | 0 of 38 |
| Acute Kidney Injury | Renal and urinary disorders | 0 of 38 | 1 of 38 |
Most frequent non-serious adverse event terms
| Event term | Organ system | ALPN-101 (Acazicolcept) | Placebo |
|---|---|---|---|
| Headache | Nervous system disorders | 2 of 38 | 5 of 38 |
| Urinary Tract Infection | Infections and infestations | 4 of 38 | 2 of 38 |
| Aphthous Ulcer | Gastrointestinal disorders | 4 of 38 | 0 of 38 |
| Abdominal Pain | Gastrointestinal disorders | 2 of 38 | 1 of 38 |
| Upper Respiratory Tract Infection | Infections and infestations | 1 of 38 | 2 of 38 |
| COVID-19 | Infections and infestations | 0 of 38 | 3 of 38 |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | 1 of 38 | 2 of 38 |
| Diarrhoea | Gastrointestinal disorders | 2 of 38 | 0 of 38 |
| Food Poisoning | Gastrointestinal disorders | 0 of 38 | 2 of 38 |
| Influenza | Infections and infestations | 0 of 38 | 2 of 38 |
Serious events with the highest arm-level rate: haemoglobin decreased (2.6%), transient ischaemic attack (2.6%), mental status changes (2.6%), acute kidney injury (2.6%).
The registry reports 2 participants with serious adverse events among 38 at risk in the ALPN-101 group and 2 among 38 at risk in the placebo group. It reports no deaths in either group. These figures describe the posted counts in the safety population, which included participants who received at least 1 dose during the treatment period. The safety observation window was Day 1 through safety follow-up, up to 28 weeks.
The registry also reports 18 participants with other adverse events among 38 at risk in the ALPN-101 group and 16 among 38 at risk in the placebo group. The label “other adverse events” should not be treated as equivalent to the serious-event category. These summaries count participants with events, not the total number of event episodes or the number of events per participant.
The listed top serious terms are Haemoglobin Decreased, Transient Ischaemic Attack, Mental Status Changes, and Acute Kidney Injury, each reported as 2.6%. The registry entries available for this analysis do not specify an arm-level breakdown for these terms. The terms also do not establish event causality or provide details about severity beyond their listing as serious terms.
Counts from a trial describe what was recorded under its definitions and follow-up. They do not establish that an event was caused by study treatment, and equal counts do not demonstrate equivalence. The registry does not report confidence intervals or a statistical comparison for these safety counts.
12. What the Result Does, and Does Not, Mean
The record documents a randomized, double-blind, placebo-controlled phase 2 study of ALPN-101 (acazicolcept) in adults with moderate to severe active SLE. Its posted primary outcome concerns safety and tolerability, assessed through participant counts for TEAEs and SAEs over a defined observation period. The available safety counts show 2 participants with serious adverse events in each group, 18 with other adverse events in the ALPN-101 group, 16 in the placebo group, and no deaths in either group.
Those observations do not establish that the treatments have the same safety profile. The record does not provide a confidence interval or formal comparison for the primary outcome, and the participant counts do not show event frequency, duration, severity details, or causality. In general, absence of a reported difference is not the same as evidence of equivalence. A claim of equivalence or noninferiority would require an appropriate prespecified design and analysis, which are not reported in the registry entries available for this analysis.
The registry’s list of secondary outcomes indicates that the study also addressed disease activity, flares, prednisone-equivalent dose, and skin activity. Their numerical results are not reported in the registry record for this analysis. The safety counts therefore cannot answer whether ALPN-101 changed those outcomes relative to placebo, nor can they establish benefit or lack of benefit.
The registry reports that the study is completed and gives enrollment and study dates. Completion status does not itself communicate the direction, size, or precision of a result. The enrollment figure also should not be substituted for each outcome’s analysis population; the primary safety population is defined by receipt of at least 1 dose.
Overall, the posted information supports a bounded descriptive account of recorded safety events. It does not support a broad claim about efficacy, a definitive comparison of safety, or a conclusion about effects beyond the study’s population and follow-up. Those questions require outcome estimates, uncertainty measures, analysis details, and clinical context that are not reported in the registry entries available for this analysis.
13. Why This Trial Matters Statistically
This study illustrates why outcome definitions and analysis populations are essential to interpreting clinical-trial results. Its primary outcome counts participants with TEAEs and SAEs, and its safety set is defined by exposure to at least 1 dose. The observation period extends from Day 1 through safety follow-up, up to 28 weeks. A reader needs all of these details to understand what the counts represent and who could contribute to them.
The registry also makes clear that safety and disease-activity questions are not interchangeable. Flare outcomes, disease-activity measures, prednisone-equivalent dose, and skin activity are listed as secondary outcomes, while the primary outcome is safety and tolerability. A safety summary cannot answer the secondary efficacy questions. Keeping those questions separate helps prevent a narrow set of event counts from being read as a complete account of trial results.
Statistically, the record is a reminder that a group count is descriptive unless accompanied by a defined comparison and uncertainty estimate. Equal serious-event counts do not demonstrate equal risks, and a difference in other-event counts does not, by itself, establish a treatment effect. Precision, analysis choices, and the planned handling of multiple outcomes affect what conclusions can be supported.
The trial’s randomized, blinded, placebo-controlled design provides important context for interpreting observed outcomes, but design labels do not replace a reported statistical plan or numerical estimates. The registry does not report the detailed methods needed to reconstruct the primary comparison, address multiplicity, or evaluate missing-data handling. These omissions matter when assessing how far conclusions can extend beyond the raw counts.
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 available registry information is limited for statistical interpretation. The primary safety outcome has several categories or time points and is not reduced to one comparison. No confidence intervals, p-values, or primary-effect estimate are reported in the registry record for this analysis. The counts can therefore be described, but the precision of a between-group contrast cannot be evaluated from those details.
Although the registry lists secondary outcomes covering flares and disease activity, their numerical results are not reported in the registry record for this analysis. The results for those outcomes cannot be inferred from the safety summaries. The detailed analysis plan, randomization implementation, allocation ratio, and roles covered by quadruple masking are not reported in the registry record.
The record does not report missing-data methods, outcome-specific analysis populations beyond the primary safety-set definition, or a strategy for multiplicity. It also does not explain how adverse events were adjudicated, how event relatedness was assessed, or how the listed serious terms were distributed by treatment group. These details would be relevant to a fuller assessment of safety and inferential results.
The study’s reported treatment period is up to 24 weeks, while safety follow-up is up to 28 weeks. The registry entries do not give the actual follow-up duration for each participant or event. The listed counts should be interpreted within the registry’s stated window, not as evidence about longer-term outcomes. The record also does not report the original sample-size justification, so the enrollment figure alone cannot establish the study’s planned precision or ability to detect a particular effect.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: ALPN-101 (Acazicolcept) in Systemic Lupus Erythematosus — NCT04835441.
- Registry record last updated 2025-08-15; status last verified 2025-08.
- Results first posted 2025-08-15.
- 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 record describes NCT04835441, a completed phase 2, multinational, randomized, double-blind, placebo-controlled, parallel-group study of ALPN-101 (acazicolcept) in adults with moderate to severe active SLE. Enrollment was 76. The study started on 2021-06-22, with primary completion on 2024-07-09.
Participants assigned to ALPN-101 received 3 milligrams/kilogram once every 2 weeks, up to 24 weeks; the comparator was matched placebo, also up to 24 weeks. The primary outcome assessed safety and tolerability through participant counts for TEAEs and SAEs from Day 1 through safety follow-up, up to 28 weeks.
The registry reports 2 participants with serious adverse events in each group, 18 with other adverse events in the ALPN-101 group, 16 in the placebo group, and no deaths in either group. It lists secondary outcomes related to flares, disease activity, prednisone-equivalent dose, and skin activity. Their numerical results, as well as detailed statistical, missing-data, and multiplicity methods, are not reported in the registry record.