This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis (NCT04990440), a randomized phase 2 study. The primary outcome is Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04990440 |
| Phase | Phase 2 |
| Condition | Dermatitis, Atopic |
| Allocation | Randomized |
| Design model | Sequential |
| Masking | Double |
| Enrollment | 6 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Janssen Research & Development, LLC |
| Results posted | Yes |
2. Clinical Question
Population
Adults with moderate-to-severe atopic dermatitis were the intended population. The primary outcome’s analysis population was defined as the full analysis set: participants randomized at Week 0 who received at least 1 dose of study intervention. The registry record lists enrollment of 6, but planned data collection and analysis for the primary endpoint could not be completed after premature study termination.
Intervention
The study evaluated bermekimab given by intravenous infusion. Parts A and B involved weekly infusions from Week 0 to Week 15, with the assigned bermekimab dose or placebo. The listed bermekimab groups were 800 mg IV in Part A and 1200 mg IV in Part B. Part C allowed a higher or lower dose than Part B, subject to the stated dose constraints and a maximum dose of Dose 3, informed by pharmacokinetic, pharmacodynamic, efficacy, and safety analysis.
Comparator
Placebo was the comparator. The registry describes the study as randomized, placebo-controlled, and double-blind. It does not report the allocation details for individual participants or the sequence in which study parts were conducted.
Primary question
The planned primary question was what percentage of participants achieved EASI-75 at Week 16: at least 75% improvement from baseline in the Eczema Area and Severity Index score. The registry record does not report the primary outcome result because premature termination prevented the planned data collection and analysis. As a result, the posted record does not provide an efficacy comparison between bermekimab and placebo for this endpoint.
3. Trial Design
This was a Phase 2a, multicenter, randomized, placebo-controlled, double-blind interventional study sponsored by Janssen Research & Development, LLC. It evaluated multiple intravenous doses of bermekimab in adults with moderate-to-severe atopic dermatitis. The registry lists an enrollment of 6 and a status of terminated. The recorded study start date is 2021-09-02, and the primary completion date is 2022-03-09.
The study was organized into parts. In Part A, participants were to receive bermekimab Dose 1 or placebo as a weekly intravenous infusion from Week 0 to Week 15. Part B used the same stated schedule for Dose 2 or placebo. In Part C, the bermekimab dose could be higher or lower than the Part B dose, subject to the dose conditions in the record, and could not exceed Dose 3. Dose selection in Part C was to be informed by pharmacokinetic, pharmacodynamic, efficacy, and safety analysis. The record does not give a complete account of how participants were assigned across parts or describe the timing of any dose decisions.
Randomization and double masking are features of the planned design, but they do not substitute for outcome data. The registry indicates that the study ended prematurely and that planned collection and analysis of the primary endpoint were not performed. The record does not report a detailed statistical plan, allocation concealment methods, or the reasons for termination. It also does not describe any completed interim analysis or the planned handling of multiple dose comparisons.
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: A total of 9 participants were screened, of which, only 6 participants were enrolled and randomized. Planned Part C was not performed due to premature study termination.
Overall Study
| Stage | Part A: Placebo | Part A: Bermekimab 800 mg IV | Part B: Bermekimab 1200 mg IV |
|---|---|---|---|
| STARTED | 1 | 4 | 1 |
| COMPLETED | 1 | 4 | 0 |
| NOT COMPLETED | 0 | 0 | 1 |
Reasons for not completing this period:
| Reason | Part A: Placebo | Part A: Bermekimab 800 mg IV | Part B: Bermekimab 1200 mg IV |
|---|---|---|---|
| Sponsor's Decision | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: The full analysis set (FAS) included all participants who were randomized at Week 0 and received at least 1 dose of study intervention. Due to premature study termination, planned data collection and analysis could not be performed for this outcome measure.
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 | Part A: Placebo | Part A: Bermekimab 800 mg IV | Part B: Bermekimab 1200 mg IV | Total |
|---|---|---|---|---|---|
| Participants analysed | 1 | 4 | 1 | 6 | |
| Age, Continuous | years | 19 | 34.5 (SD 16.34) | 47 | 34 (SD 15.47) |
| Sex: Female, Male: Female | Participants | 0 | 3 | 0 | 3 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 1 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 1 | 3 | 0 | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: ARGENTINA | Participants | 1 | 3 | 0 | 4 |
| Region of Enrollment: UNITED STATES | Participants | 0 | 1 | 1 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline), measured over Week 16.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the percentage of participants achieving EASI-75 at Week 16. EASI is a measure of atopic dermatitis severity and extent. It scores erythema, infiltration, excoriation, and lichenification across the head, trunk, upper limbs, and lower limbs. Clinical signs are rated by severity, while affected skin area is assessed within each body region. The resulting total score ranges from 0.0 to 72.0, with higher scores indicating greater disease severity.
EASI-75 is a responder endpoint: it identifies participants whose EASI score improved from baseline by at least 75%. A responder threshold can express change in a way that is easy to interpret clinically, while the underlying EASI score captures both signs and extent of disease. However, converting a score into a responder outcome also means that participants just on either side of the threshold are classified differently, even if their measured changes are similar.
The endpoint was planned for assessment at Week 16. The registry record says that the study’s premature termination prevented the planned data collection and analysis for this outcome. It therefore supplies the endpoint definition but not the percentage of responders, an estimate comparing treatment groups, or an uncertainty interval.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive fact is that the registry record does not report a result for the primary endpoint. EASI-75 was planned at Week 16, but the record states that premature termination meant the planned data collection and analysis could not be performed. Consequently, there is no posted primary-endpoint estimate on which to base a treatment-group comparison. The record does not establish either a difference between bermekimab and placebo or an absence of a difference.
The enrollment listed is 6. That small enrollment is relevant context for the amount of information available, but it cannot replace the missing endpoint results. The record gives no EASI-75 responder counts, group percentages, treatment contrast, confidence interval, or primary-endpoint test result. It also reports no completed analyses. Thus, claims about the size, direction, or precision of an efficacy effect are not supported by the registry results.
Safety summaries are present for the listed groups, but these are not efficacy findings. In Part A, the placebo group lists 1 participant at risk and 0 with a serious adverse event; the Part A bermekimab 800 mg IV group lists 4 at risk and 0 affected. In Part B, the bermekimab 1200 mg IV group lists 1 at risk and 1 affected by a serious adverse event. These small group counts describe what the record reports and should not be treated as stable estimates of comparative safety.
The record lists accidental overdose as a serious adverse event term at 100.0%. This descriptive entry does not provide enough information to infer the cause, circumstances, or broader risk of that event. The registry also lists other adverse-event counts, pharmacokinetic and immunogenicity outcomes, and planned safety outcomes. Those entries do not recover the missing primary endpoint.
Statistical precision cannot be assessed for the primary question because neither an effect estimate nor an interval is reported. In general, a confidence interval conveys the range of effect values compatible with the data and statistical model; no such interval is reported for EASI-75. General caution about uncertainty is especially important when group sizes are limited, but the key limitation in this record is that the planned endpoint analysis is unavailable.
9. Statistical Methods Explained
The registry describes a randomized, double-blind, placebo-controlled study. Randomization is generally used to reduce systematic differences between treatment groups at assignment, while masking can reduce the influence of expectations on participant experience, clinical assessment, and reporting. These design features are relevant to how a completed comparison might be interpreted. They do not, on their own, demonstrate that a comparison was completed or that its results are available. The registry does not report the detailed randomization or masking procedures.
What does the primary endpoint measure?
EASI combines assessments of clinical signs and affected area across body regions. The registry describes ratings for erythema, infiltration, excoriation, and lichenification on the head, trunk, upper limbs, and lower limbs. The total score ranges from 0.0 to 72.0, and higher scores reflect greater disease severity. EASI-75 converts change from baseline into a responder classification: improvement of at least 75% meets the endpoint definition. The outcome was planned for Week 16.
For a responder endpoint, a group percentage would ordinarily be calculated from the number of participants meeting the response definition and the relevant analysis population. A comparison could then summarize how response differed between groups, with an uncertainty estimate. Those are general descriptions of common analysis steps, not a description of completed work in this study. The registry record does not report responder counts, group percentages, a treatment contrast, or an uncertainty estimate for EASI-75.
What does the record say about the analysis population?
The planned full analysis set included all participants randomized at Week 0 who received at least 1 dose of study intervention. This definition indicates that randomization alone was not sufficient for inclusion in that set; receipt of study intervention was also part of the stated criterion. The record does not report how many participants met the definition in each group. Because primary data collection and analysis were not completed, the population definition cannot be used to reconstruct an outcome result.
How should uncertainty and statistical tests be understood?
In general, an estimate describes the observed treatment contrast, while a confidence interval communicates uncertainty around that estimate under the assumptions of the analysis. A hypothesis test addresses how compatible the observed data are with a specified null hypothesis under a statistical model. These concepts require outcome data and an analysis; they cannot be inferred from the trial design or from enrollment alone. No primary-endpoint estimate, confidence interval, or test result is reported in the registry record.
The record lists 0 analyses. It does not report a statistical analysis plan describing the model, covariate adjustment, missing-data procedures, or any approach for multiple comparisons among doses. Those details are not reported in the registry record, so the intended methods beyond the stated endpoint and analysis population should not be assumed.
What do the planning assumptions mean?
The record describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event outcomes, the illustration uses a total number of events based on the Schoenfeld method; for other outcomes, it gives participants per arm. These are general planning calculations, not observed trial outcomes or evidence of achieved power. The record does not give a completed primary-endpoint effect estimate to interpret as an observed efficacy result, and no numerical planning outputs are stated in the record.
Over-dispersion is a general issue when variability in count or rate data exceeds what a simple model assumes; ignoring it can make uncertainty appear too small. It is not possible to say whether over-dispersion was relevant to a particular analysis because the registry record does not describe a completed primary analysis or its model.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 14 outcome measures, including the primary EASI-75 endpoint and secondary outcomes concerning bermekimab concentrations, antibodies to bermekimab, and adverse events. When a study evaluates multiple endpoints, doses, or time points, repeated statistical testing can increase the chance of finding an apparently notable result by chance. General methods for addressing this include specifying a primary comparison in advance or adjusting interpretation for multiple testing. The registry record does not report a multiplicity strategy, a hierarchy of tests, or which comparisons would have been considered confirmatory.
The record reports 0 analyses. In particular, planned data collection and analysis for the primary endpoint could not be performed because the study was terminated prematurely. Therefore, there is no reported primary-endpoint result for which to assess multiplicity-adjusted or unadjusted inference. The record does not report whether any secondary outcome analyses were completed or how results across doses and outcomes were intended to be handled.
The primary endpoint’s population was defined as participants randomized at Week 0 who received at least 1 dose of study intervention. However, the registry does not give a group-level accounting of participants included in that population or describe how missing observations would have been addressed. It does not report imputation methods, assumptions about why data might be missing, or sensitivity analyses. Missing-data methods can affect conclusions when participants lack outcome measurements, but the approach cannot be inferred from this record. The stated consequence of termination is that planned primary data collection and analysis were not performed.
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 |
|---|---|---|---|
| Part A: Placebo | 0 | 1 | 0.0% |
| Part A: Bermekimab 800 mg IV | 0 | 4 | 0.0% |
| Part B: Bermekimab 1200 mg IV | 1 | 1 | 100.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Part A: Placebo | 0 of 1 |
| Part A: Bermekimab 800 mg IV | 0 of 4 |
| Part B: Bermekimab 1200 mg IV | 0 of 1 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Part A: Placebo | 1 of 1 |
| Part A: Bermekimab 800 mg IV | 3 of 4 |
| Part B: Bermekimab 1200 mg IV | 0 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | Part A: Placebo | Part A: Bermekimab 800 mg IV | Part B: Bermekimab 1200 mg IV |
|---|---|---|---|---|
| Accidental Overdose | Injury, poisoning and procedural complications | 0 of 1 | 0 of 4 | 1 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Part A: Placebo | Part A: Bermekimab 800 mg IV | Part B: Bermekimab 1200 mg IV |
|---|---|---|---|---|
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | 1 of 1 | 2 of 4 | 0 of 1 |
| Otitis Externa | Infections and infestations | 0 of 1 | 1 of 4 | 0 of 1 |
| Vulvovaginal Candidiasis | Infections and infestations | 0 of 1 | 1 of 4 | 0 of 1 |
| Hypokalaemia | Metabolism and nutrition disorders | 0 of 1 | 1 of 4 | 0 of 1 |
Serious events with the highest arm-level rate: accidental overdose (100.0%).
The serious adverse event summaries are descriptive counts for the groups listed in the registry. Part A: Placebo lists 1 participant at risk and 0 affected by a serious adverse event. Part A: Bermekimab 800 mg IV lists 4 at risk and 0 affected. Part B: Bermekimab 1200 mg IV lists 1 at risk and 1 affected. The record lists accidental overdose at 100.0% among the serious adverse event terms.
These entries should be read in the context of the small group counts and the study’s termination. A count in a small group is not a precise estimate of how often an event would occur in a broader population, and a difference in counts is not by itself evidence of a treatment-related difference. The term and percentage do not establish how the event occurred or whether it was considered related to study intervention. The record also reports 0 deaths in each listed group.
Other adverse-event counts are reported separately: Part A placebo lists 1 at risk and 1 affected; Part A bermekimab 800 mg IV lists 4 at risk and 3 affected; Part B bermekimab 1200 mg IV lists 1 at risk and 0 affected. These summaries are not the primary efficacy outcome, and they do not provide a basis for broader safety conclusions.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized, double-blind, placebo-controlled Phase 2a study designed to evaluate bermekimab in adults with moderate-to-severe atopic dermatitis. Its planned primary endpoint was the percentage of participants achieving EASI-75 at Week 16. The record also defines the full analysis set and lists pharmacokinetic, immunogenicity, and safety outcomes.
What the posted results do not provide is the primary endpoint result. The registry explicitly states that premature termination prevented planned data collection and analysis for EASI-75. There is no reported response percentage or treatment comparison for that endpoint. As a result, the record does not show whether bermekimab differed from placebo on the planned primary outcome, how large any difference might have been, or how precisely it could be estimated.
The absence of a reported primary result is not evidence that the treatments had the same effect, nor is it evidence that bermekimab had a beneficial or harmful effect on the endpoint. Those conclusions require outcome data and an analysis that are not reported. Likewise, the adverse-event counts are limited descriptive observations and should not be treated as definitive comparative safety estimates.
General statistical interpretation distinguishes the existence of a planned study from the availability of analyzable results. Randomization and masking describe aspects of design; they do not supply missing measurements. The record’s enrollment and safety summaries give context about the study but cannot substitute for the planned efficacy analysis. A reader can identify the question investigators intended to address, but the posted record does not answer that question with an estimated treatment effect.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a registered endpoint and a reported endpoint result. The registry defines EASI-75 clearly, specifies Week 16, and describes the intended analysis population. Yet it also states that premature termination meant planned collection and analysis could not be performed. A clearly specified outcome is not itself evidence about the outcome.
The design also involved multiple bermekimab doses and separate study parts. Such a design can raise questions about which dose comparisons are central, how evidence across parts is combined, and how multiple outcomes are handled. Those are important statistical questions in general, but the registry record does not report a completed analysis plan that answers them. The record’s dose-selection description refers to pharmacokinetic, pharmacodynamic, efficacy, and safety analysis for Part C, but it does not provide a completed efficacy comparison.
The small enrollment and limited group counts make precision a central consideration for the descriptive safety summaries. Even when counts are recorded, they do not necessarily support stable estimates of event frequency or differences between groups. For the primary question, the more fundamental issue is that the result is unavailable, so precision cannot be evaluated through an effect estimate or interval.
For clinical researchers and statisticians, the record underscores why interpretation depends on both design and execution. Randomization, masking, outcome definitions, and population rules describe how a study was intended to generate evidence. The availability of results, transparent analysis methods, and an account of missing data are also necessary for evaluating what the evidence says. Here, the registry supports description of the study’s intended question and limited safety counts, but not a statistical conclusion about the primary efficacy endpoint.
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 is premature termination. The registry record states that planned data collection and analysis for the primary endpoint could not be performed. Consequently, the intended Week 16 EASI-75 comparison has no reported result. This prevents assessment of the direction, magnitude, and precision of the planned efficacy contrast.
Enrollment was 6, and the listed group counts are limited. The adverse-event summaries therefore describe small numbers of participants and cannot establish precise event rates or reliable differences between treatment groups. The record does not provide details about the reasons for termination or a full account of participant disposition, so the circumstances leading to the unavailable primary result cannot be evaluated from the registry record.
The registry does not report a detailed statistical analysis plan, including any adjustment for multiple comparisons, model specification, missing-data strategy, or sensitivity analyses. It also does not report a completed primary analysis, inferential test, or confidence interval. Although the planned analysis population is defined, group-specific membership in that population is not reported.
The record describes a Part C dose-selection approach informed by several kinds of analysis, but it does not report completed Part C results or a detailed account of how dose selection was conducted. Safety terms and counts are descriptive and do not establish causality. These limitations mean the record is useful for understanding the intended design and the reason the primary result is unavailable, but it cannot support a full evaluation of efficacy or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis — NCT04990440.
- Registry record last updated 2023-05-24; status last verified 2023-04.
- Results first posted 2023-05-24.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT04990440 is a terminated Phase 2a randomized, double-blind, placebo-controlled study of intravenous bermekimab for adults with moderate-to-severe atopic dermatitis. It lists enrollment of 6, a start date of 2021-09-02, and a primary completion date of 2022-03-09. The planned primary endpoint was EASI-75 at Week 16.
The registry states that premature termination prevented planned collection and analysis of the primary endpoint. It therefore reports no primary efficacy comparison. The record includes limited adverse-event counts for the listed groups, as well as planned pharmacokinetic, immunogenicity, and safety outcomes. It does not report a detailed statistical analysis plan or completed analyses.