The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis (NCT05498467), a randomized phase 3 study. The primary outcome is Clinical Reaction.

2. Clinical Question

The clinical question is framed around a score-based clinical reaction rather than a reported continuous score change. Its description refers to participants with a lower clinical ICDRG scoring in the active-treatment group compared with placebo. It does not specify how the score categories were formed, how a participant was classified, or how a between-group comparison was calculated. Those details are not reported in the registry record.

The record identifies allergic contact dermatitis as the condition and says that the study investigates whether anakinra can ameliorate the condition in participants with known nickel allergy. That statement describes the study’s aim, not a result. With no reported primary outcome analysis, the record does not establish the direction or size of any between-group difference, nor how precisely such a difference was estimated.

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group Phase 3 trial comparing anakinra with placebo. It lists Herlev and Gentofte Hospital as the sponsor. Enrollment is recorded as 20. The study started on 2022-10-11, reached primary completion on 2023-12-01, and has a status of completed.

In a randomized design, allocation to treatment groups is determined by a chance-based process. In general, randomization is intended to reduce systematic differences between groups at the start of a trial; it does not guarantee that every characteristic will be balanced, particularly in a small study. The method used to generate the allocation sequence, how allocation was concealed, and whether any stratification was used are not reported in the registry record.

Double masking means that the record identifies the study as masked at two levels, but it does not state which roles were masked or how masking was maintained. The record does not report whether the treatments had matching appearance or administration, or whether masking was assessed. These details matter because knowledge of treatment assignment could influence care, outcome assessment, or participant reporting.

The parallel design indicates that participants were assigned to a treatment group rather than described as switching between treatments. The intervention list names anakinra and Sodium Chloride 9mg/ml Injection; the arm labels identify anakinra and placebo. Additional details about dose, schedule, treatment duration, adherence, and concomitant care are not reported in the registry record. The listed primary-outcome timeframe is 2 months, but the record does not explain how that timeframe relates to treatment exposure or other visits.

Although the trial is marked completed, completion status is not equivalent to a posted result. No primary outcome analysis is reported in the registry record, so the study’s stated clinical question cannot be answered from the posted information.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Clinical Reaction, measured over 2 months.

The registered primary outcome is titled Clinical Reaction, uses participants as its unit, and is described as the number of participants with a lower clinical ICDRG scoring in the active treatment group compared to placebo. The timeframe is 2 months. This is presented as a count of participants with an event, rather than as a mean score or a time-to-event measure.

A participant count can be useful when the clinical question concerns how many people meet a defined response or classification. It can make a clinical outcome more interpretable than a score alone, provided that the classification rule is specified and applied consistently. The registry record does not define the scoring categories, the threshold for being classified as lower, or the exact event rule. It also does not report the outcome results or a comparison estimate.

The record flags the primary outcome as having several categories or time points and not being reduced to one comparison. This leaves the intended comparison unclear: a count needs a defined event and a clearly stated group contrast to support an interpretable estimate. Details on outcome assessment, assessor training, blinding of assessors, and handling of missing measurements are not reported in the registry record.

Thus, the endpoint identifies a clinically oriented assessment and a measurement timeframe, but the posted information is insufficient to determine how the measure was operationalized or what it showed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does randomization contribute? Randomization assigns participants to groups through a chance-based process. As a general statistical principle, it helps limit systematic allocation bias and supports a fair comparison, because treatment assignment is not intentionally determined by a participant’s prognosis. Randomization does not remove chance imbalances, measurement error, missing outcomes, or bias arising after assignment. The record identifies the trial as randomized but does not report the sequence-generation method, allocation concealment, or any stratification factors.

What does masking contribute? The record describes the study as double-masked. In general, masking can reduce the chance that expectations affect treatment delivery, participants’ reports, or outcome assessments. The exact roles masked and the practical procedures used are not reported in the registry record. It is therefore not possible to assess how effectively masking was maintained or whether the outcome assessor was masked.

How should a count outcome be understood? The primary outcome is labeled as a count of participants with an event. For a binary outcome, each participant is generally classified as meeting or not meeting a prespecified event definition. The group event counts can then support a comparison, such as a difference in event frequency or a relative measure. These are general examples of statistical approaches, not methods confirmed for this trial. The registry record does not report the event definition, the observed outcome counts, the chosen effect measure, or the method used to estimate it. The description about lower clinical ICDRG scoring does not by itself define how participants were classified.

Why does the analysis specification matter? A valid interpretation requires clarity about the comparison being estimated, the analysis population, and how participants with missing outcomes are handled. For example, an analysis based on assigned groups answers a different practical question from an analysis limited to participants who completed treatment. These are general distinctions; the registry record does not report which population was used or whether any analysis was performed. It lists no analyses.

The record also flags the primary outcome as involving several categories or time points and not being reduced to one comparison. If several categories, time points, or contrasts are examined, the number and selection of comparisons can affect how results are interpreted. General statistical practice may address this through prespecified outcome selection or multiplicity procedures. The registry record does not report an analysis plan or any multiplicity adjustment, so it is not possible to determine how multiple possible comparisons were handled.

How should uncertainty be assessed? A point estimate describes the observed effect under a chosen statistical definition. A confidence interval, in general, describes the range of effect values reasonably compatible with the data and the statistical model. Wider intervals indicate less precision; an interval that includes values on both sides of a null effect can leave the direction or clinical importance uncertain. No primary outcome estimate or confidence interval is reported in the registry record, so precision cannot be evaluated. A p-value, if reported, would address compatibility with a specified null hypothesis under model assumptions; it would not by itself describe the size or clinical importance of an effect. No primary outcome p-value is reported.

What do the sample-size assumptions mean? The planning description specifies a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect to detect defined as a stated fraction of the observed effect. These are planning assumptions, not evidence that a particular effect was observed or that the trial had a particular probability of detecting it. The description states that sample-size illustrations are planning exercises, not observed power. It also distinguishes participant-per-arm calculations from total-event calculations for time-to-event outcomes. The primary outcome is a participant count, but numerical sample-size illustrations and the effect value used for them are not reported in the registry record details available for this analysis.

In general, a normal approximation is a mathematical simplification for calculating uncertainty or planning sample size. Its adequacy depends on the data and model; sparse event counts can make approximations less reliable. That general consideration is relevant to count-based outcomes, but the primary outcome event counts are not reported, so the fit of any approximation cannot be assessed. The record does not report the statistical model, adjustment variables, software, interim analyses, or the trial’s own sample-size justification. None should be inferred from the planning assumptions alone.

Why are effect size and uncertainty both needed? A result can be statistically compatible with a range of effects, and its clinical interpretation depends on both that range and a meaningful outcome definition. A small or imprecise study may leave substantial uncertainty even if its point estimate appears notable. Conversely, statistical significance alone would not establish clinical importance. These are general principles. For this trial, there is no reported primary estimate or uncertainty interval with which to apply them.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is flagged in the registry as involving several categories or time points and not being reduced to one comparison. This matters because several possible contrasts can create more than one opportunity to identify a difference. In general, a prespecified primary comparison and appropriate multiplicity handling can help keep interpretation tied to the original question. The registry record does not report the planned comparisons, any hierarchy among outcomes, or any adjustment for multiplicity.

The record lists one primary outcome measure and no analyses. The existence of a registered outcome does not show that a result was analyzed or reported. There is no reported primary-outcome estimate, test, or confidence interval with which to judge the outcome.

Missing-data handling is not reported in the registry record. The record does not state how many participants contributed primary-outcome measurements, whether anyone withdrew or missed assessment, or how incomplete observations were treated. In general, missing outcomes can affect both the estimated effect and its uncertainty, especially when the reasons for missingness differ across groups or relate to outcome status. Analyses may use assumptions or sensitivity checks to assess this, but none are reported.

The analysis population is also not reported in the registry record. It is therefore unclear whether the intended analysis was based on randomized assignment, treatment received, or another population. These distinctions can affect what comparison an estimate represents. Without the analysis population and missing-data approach, the scope and robustness of any primary result cannot be evaluated.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry record reports serious adverse event counts for anakinra as 0 affected among 12 participants at risk, and for placebo as 0 affected among 8 participants at risk. For other adverse events, it reports 0 affected among 12 at risk with anakinra and 0 affected among 8 at risk with placebo. Deaths are reported as 0 in each group. No serious adverse event terms are listed.

These figures are counts from the registry record. They describe what was recorded for the listed categories, not a guarantee that the underlying event risk is zero. Counts can be difficult to interpret without information about event definitions, collection procedures, duration of observation, completeness of follow-up, and whether events were judged related to treatment. Those details are not reported in the registry record. The record also does not provide information about the severity or type of other adverse events beyond the category counts.

Because there are no reported affected participants in these categories, the counts do not allow a comparative estimate of the frequency or relative risk of events. They should not be read as evidence that the two groups have identical safety profiles. They are a limited descriptive safety record, distinct from a complete assessment of benefit and risk.

12. What the Result Does, and Does Not, Mean

The record establishes the trial’s question and broad design: a randomized, double-masked, parallel comparison of anakinra with placebo in allergic contact dermatitis, with a clinical reaction outcome at 2 months. It also reports the trial as completed and gives safety counts for serious adverse events, other adverse events, and deaths.

What it does not establish is the result of the primary comparison. There are no reported group-specific primary outcome counts, effect estimate, confidence interval, or test. The description of participants with a lower clinical ICDRG scoring does not provide a usable result or a complete event definition. The registry’s note that the outcome involved several categories or time points and was not reduced to one comparison further limits interpretation.

Accordingly, the posted information cannot show whether the primary outcome favored either group, how large a difference may have been, or how precisely that difference was estimated. It cannot establish whether any observed difference would be clinically important. The design features are relevant to judging a reported result, but they cannot substitute for one.

The reported zero adverse-event counts are likewise limited observations, not proof of no risk. Without details on ascertainment and follow-up, they do not provide a complete safety assessment. Nor do they resolve the primary clinical question.

These limits concern what can be concluded from the registry record, not what may have occurred during the study. A completed study can have results that are not reported in the registry record. For this trial, the available record supports a description of the design and certain safety counts, but not a conclusion about the primary treatment comparison.

13. Why This Trial Matters Statistically

This trial is statistically notable because it combines a randomized, double-masked design with a primary outcome whose registry description is not fully operationalized. Randomization and masking are important design features, but their value for interpretation depends on a clear outcome definition and a reported analysis. Without those pieces, readers cannot connect the intended clinical question to a quantified treatment contrast.

The outcome is expressed as a count of participants, while its description refers to lower clinical scoring and the registry flags several categories or time points. This illustrates a general principle: an endpoint needs a transparent rule for classifying participants and a clearly specified comparison. If different categories or time points could support different conclusions, prespecifying the primary contrast is important for avoiding selective emphasis.

The record also shows why reporting uncertainty matters. A group count alone cannot show the size or precision of a between-group effect. Confidence intervals and a clearly stated effect measure would help readers assess which effects are compatible with the data, while the analysis population and missing-data approach would clarify whom the estimate represents. Those primary statistical results are not reported in the registry record.

Finally, the safety counts demonstrate the limits of interpreting zero events in a registry summary. They are relevant descriptive information, but their meaning depends on ascertainment and follow-up details that are not reported. The trial therefore serves as a useful example of the distinction between a registered design, a completed study, and an interpretable set of results.

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 limitation of interpretation is that the registry record does not report a primary outcome analysis. It provides no group-specific clinical reaction counts, treatment-effect estimate, confidence interval, or statistical test. The primary clinical question therefore remains unanswered by the posted information.

The endpoint description is also incomplete for statistical interpretation. The record refers to participants with a lower clinical ICDRG scoring in the active group compared to placebo, but it does not define the score categories, classification threshold, or exact event rule. It flags the outcome as having several categories or time points and not being reduced to one comparison. The intended primary contrast is consequently unclear.

Further details needed to assess the analysis are not reported in the registry record: the allocation method, masking procedures, analysis population, missing-data approach, outcome-assessment procedures, statistical model, covariate adjustment, and any multiplicity strategy. The record does not provide the trial’s sample-size justification or report interim analyses. Planning assumptions alone do not establish which analysis was actually used.

Safety interpretation is limited to the reported counts. The record does not give event definitions, ascertainment procedures, follow-up completeness, or attribution to treatment. Zero reported events in a category should not be taken as proof that risk is absent.

Finally, the record’s completed status and design description do not resolve these reporting gaps. The record may not represent every analysis conducted during the study, but no further result or explanation is reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis — NCT05498467.
• Registry record last updated 2025-05-20; status last verified 2025-05.
• Results first posted 2025-05-20.
• 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.

18. Record Summary

The registry record describes NCT05498467, titled “The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis.” It identifies Herlev and Gentofte Hospital as sponsor and lists the study as Phase 3, randomized, double-masked, and parallel. Enrollment is recorded as 20; the status is completed, with a start date of 2022-10-11 and primary completion date of 2023-12-01.

The study aim concerns anakinra versus placebo in participants with known nickel allergy. The listed primary outcome is Clinical Reaction, a participant count assessed at 2 months. No primary outcome analysis is reported in the registry record. Safety counts report 0 serious adverse events and 0 other adverse events in each group, and 0 deaths in each group; the listed at-risk counts are 12 for anakinra and 8 for placebo.