A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT) (NCT04417894), a randomized phase 3 study. The primary outcome is Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16.

2. Clinical Question

3. Trial Design

This was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of dupilumab in adults and adolescents with moderate-to-severe atopic hand and foot dermatitis. The registry record lists 133 participants enrolled. The posted primary outcome has 66 participants in the matching-placebo arm and 67 in the Dupilumab Q2W arm.

Participants in both arms received subcutaneous study treatment once every 2 weeks, after a loading dose on Day 1. The registry describes quadruple masking, in addition to the study's double-blind title. The record does not explain which roles were included in the quadruple masking designation.

The study started on 2021-04-14, had primary completion on 2022-08-31, and is listed as completed. The primary objective was to assess dupilumab efficacy on skin lesions. Secondary objectives included other symptoms and impacts, safety and tolerability, systemic exposure, and immunogenicity.

The registry record does not report the randomization ratio, the method used to generate or conceal the allocation sequence, or the trial's original sample-size justification. It also does not give enough detail to reconstruct all analysis populations or follow-up procedures. These omissions limit what can be inferred about design choices beyond the stated randomized, masked, parallel-group comparison.

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 170 participants were screened, 37 participants failed screening, and 133 participants were randomized. Of the 37 screen failures: 2 withdrew consent, 33 did not meet inclusion/exclusion criteria, 1 was lost to follow-up and 1 was for an unknown reason.

Overall Study

Reasons for not completing this 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.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16, measured over At week 16.

The primary endpoint is the percentage of participants with a hand and foot Investigator Global Assessment score of 0 or 1 at week 16. The IGA is a 5-point assessment of hand and foot atopic dermatitis severity and clinical response. Its categories run from 0, clear, through 1, almost clear, 2, mild, 3, moderate, and 4, severe. The scale is based on erythema and papulation or infiltration, and higher scores indicate more severe disease.

Expressing the endpoint as a percentage meeting a defined score threshold makes the result a binary outcome: each participant either meets the 0-or-1 criterion at the specified assessment or does not. Comparing the percentages between randomized arms describes how often that endpoint occurred in each group. This makes the result straightforward to interpret, while the threshold also means that participants with scores just outside it are counted differently from those who meet it.

The endpoint captures an investigator assessment at week 16. It does not by itself summarize every symptom or impact of hand and foot dermatitis, nor does it describe the course of disease beyond that assessment. Other posted outcomes address symptoms and impacts such as pruritus, pain, sleep, and affected surface area.

7. Results Posted in the Registry

• Dupilumab Q2W: 40.3% (27/67) versus 16.7% (11/66) on control; risk difference 23.6 percentage points (95% CI 8.8 to 38.4), risk ratio 2.42 (1.31–4.46); unadjusted two-proportion z-test p = 0.003.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Dupilumab Q2W: 52.2% (35/67) versus 13.6% (9/66) on control; risk difference 38.6 percentage points (95% CI 24.1 to 53.1), risk ratio 3.83 (2.00–7.33); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Dupilumab Q2W than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Dupilumab Q2W: 61.2% (41/67) versus 16.7% (11/66) on control; risk difference 44.5 percentage points (95% CI 29.8 to 59.3), risk ratio 3.67 (2.07–6.51); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for Dupilumab Q2W than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Dupilumab Q2W: mean -4.66 versus -1.93 on control; difference -2.73 (95% CI -3.92 to -1.54), standardized effect d = -0.78; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Dupilumab Q2W than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes broaden the question beyond investigator-rated skin status. They include pruritus thresholds and change, pain, sleep, lesion signs, affected surface area, and other symptom or impact domains. For the secondary results with arm values posted, the direction generally favors dupilumab on the reported measures. This pattern is consistent with the primary endpoint's arm contrast, but each outcome measures a different aspect of the condition and should be interpreted on its own terms.

The posted results do not include sponsor analyses for most of the secondary outcomes. The registry record lists 19 secondary outcomes as posted, while the details available for individual outcomes vary. A result listed without a sponsor-reported test or interval should not be assigned the same evidential status as an endpoint with a stated sponsor analysis.

Multiple outcomes create a multiplicity concern: the more comparisons examined, the greater the possibility of at least one apparently notable finding by chance. The registry record does not report whether a hierarchy, adjustment, or other multiplicity strategy was used. Consequently, unadjusted secondary results carry less weight as confirmatory evidence than the primary result. They can still provide descriptive context and help show whether observed differences extend across related symptoms and impacts, but the registry record alone cannot establish how strongly the secondary family as a whole supports a conclusion.

The primary outcome remains the prespecified central comparison described in the record. Secondary outcomes complement it rather than redefine it, and differences among their measurement scales, time points, and analysis methods matter when considering the overall pattern.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16
• Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16
• Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS
• Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16
• Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS
• Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS
• Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)
• Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS

9. Statistical Interpretation

10. Statistical Methods Explained

General: binary outcome comparison. The primary endpoint records whether each participant reached IGA 0 or 1 by week 16. The arm percentages describe the observed proportion meeting that threshold. A risk difference expresses the difference between the two proportions on the probability scale. The recalculated estimate is 0.236, with a 95% confidence interval from 0.088 to 0.384. The calculation is described as a simple, unadjusted recalculation from posted summary statistics; it is not the same as the sponsor's reported stratified analysis.

General: confidence intervals and tests. A confidence interval communicates estimation uncertainty around an effect estimate. A p-value addresses how compatible the observed data are with a null comparison under a statistical model; it does not quantify the probability that the null hypothesis is true, and it does not measure clinical importance. The sponsor reported p =0.003 from a Cochran-Mantel-Haenszel superiority analysis. The recalculated unadjusted p-value is 0.003. The record does not give the details needed to determine every adjustment or implementation choice behind the sponsor's analysis.

General: stratified versus unadjusted analyses. The Cochran-Mantel-Haenszel method can combine evidence across strata while accounting for those strata in the comparison. An unadjusted calculation from overall arm summaries does not incorporate such stratification. Thus, a sponsor analysis and a simple recalculation can be statistically distinct even when their p-values are similar. The registry record does not describe the stratification factors for the primary analysis.

General: continuous outcomes. One posted secondary result is a change score for weekly average daily hand and foot peak pain NRS. The arm values are least-squares means, with standard errors of 0.432 for placebo and 0.426 for dupilumab. The recalculated mean difference is -2.73, with a 95% confidence interval from -3.919 to -1.541. A mean difference summarizes the contrast between arm averages; a standard error describes estimated uncertainty in an arm mean. The recalculation uses an approximate pooled standard deviation, as indicated in the posted calculation, and is not a substitute for any sponsor model that may have included additional terms.

General: planning illustrations. The sample-size figures use a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects set to stated fractions of the observed effect. For binary outcomes, the figures describe participants per arm. They illustrate how sample requirements vary under those assumptions, not the original design process. The trial's own sample-size assumptions are not reported in the registry record.

General: multiplicity. When a study evaluates multiple endpoints, repeated testing can increase the chance of at least one apparently unusual result under null effects. Procedures such as hierarchical testing or adjusted significance thresholds can address this issue, but the registry record does not report a multiplicity plan. It also does not give enough information to establish whether the posted secondary tests were confirmatory or exploratory. The primary and secondary findings should therefore be read with their different evidential roles in mind.

The registry record lists 20 outcome measures and 19 posted secondary outcomes. It reports only two sponsor analyses in the posted results: the primary comparison and one secondary comparison. The other outcome entries do not include sponsor-reported analysis results in the record presented. The full statistical analysis plan, details of covariate adjustment, the analysis population definitions, and missing-data methods are not reported in the registry record. Without these details, the reported results cannot be fully reconstructed from the registry summary alone.

11. Confidence Intervals and Precision

The primary risk-difference estimate is 0.236, with a 95% confidence interval from 0.088 to 0.384. The interval does not include zero, so the recalculated estimate is distinguishable from no arm difference at the conventional interpretation of that interval. The range still leaves uncertainty about the size of the contrast: its lower and upper bounds represent materially different effect estimates.

Confidence intervals reflect sampling uncertainty under the calculation's assumptions. They do not capture all sources of uncertainty, such as possible bias from missing outcomes, measurement choices, or analysis decisions. Those details are not reported in the registry record. The arm percentages and confidence interval should therefore be understood as a statistical description of the posted results rather than a complete account of every uncertainty affecting the trial.

The primary sponsor analysis reports p =0.003 but no effect estimate or confidence interval. Its p-value indicates evidence against the null comparison under that analysis, but it does not show the range of effect sizes supported by the data. The recalculated interval fills in an estimate of precision from the posted arm summaries, while remaining unadjusted and distinct from the sponsor's reported method.

Interpretation also depends on the endpoint definition and time point. The interval concerns the percentage meeting IGA 0 or 1 at week 16. It does not quantify uncertainty for other outcomes or later follow-up.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations, not counts observed in the trial. For these binary outcomes, the figures are participants per arm; they are not total event counts. The calculation assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect set to the stated fraction of the observed effect. The original trial design assumptions are not reported in the registry record.

The 80% power column gives the estimated participants per arm under those assumptions for a design intended to have an 80% chance of detecting the specified effect if that effect were the true one. The 90% power column gives the corresponding number for a design intended to have a 90% chance. These are prospective planning concepts: power is calculated for an assumed effect and study design, not derived as a verdict on the completed trial.

The rows vary the target effect from 100% of the observed effect to 75% and 50% of that effect. Smaller target effects require more participants per arm to achieve the same planned power under the stated assumptions. The figures are sensitive to those assumptions and should not be read as a reconstruction of the trial's enrollment target or its rationale. This is not observed power.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.167; treatment proportion p₁ = 0.403; average p̄ = 0.285.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6383 = 1.2510.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6160 = 0.5185.
4. n = (1.2510 + 0.5185)² / (0.2363)² = 56.1, rounded up to 57 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.166666666666667                          # control proportion
p1 <- 0.402985074626866                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(4417894)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 57 (80% power), 75 (90% power)
 75% of observed effect: n per arm = 94 (80% power), 126 (90% power)
 50% of observed effect: n per arm = 196 (80% power), 262 (90% power)
power.prop.test: 56.1 
Simulated power at n = 57 per arm: 0.819 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

For the primary endpoint, the sponsor reported a Cochran-Mantel-Haenszel superiority analysis with p =0.003. The recalculation from the posted arm summaries is unadjusted and gives p =0.003, alongside a risk difference of 0.236 and a 95% confidence interval from 0.088 to 0.384. The recalculation adds an effect estimate and interval based on the summary data, but it is not a replacement for the sponsor's analysis.

For one secondary endpoint, the sponsor reported a Mantel Haenszel difference of 38.6, with a 95% confidence interval from 24.06 to 53.15 and p < 0.001. The simple recalculated unadjusted p-value for that result is <0.001. These values come from distinct reported and recalculated analyses, and should not be treated as identical quantities. The registry record does not report sponsor analyses for the other secondary results listed in the record.

The discrepancy flag is false. The sponsor's analyses and the simple recalculations should nevertheless be kept clearly distinguished because their methods and reported information differ.

15. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when a trial assesses many outcomes or performs multiple comparisons. Even if no underlying effect exists, repeated testing can make at least one result appear more unusual by chance. Common approaches include preplanned testing sequences or adjustments to account for multiple comparisons. The registry record lists 20 outcome measures, including 19 posted secondary outcomes, but does not report a multiplicity strategy. It is therefore not possible to determine from this record whether secondary tests were adjusted, hierarchically ordered, or designated as exploratory.

The record identifies a primary outcome and gives a sponsor-reported superiority analysis for it. That provides a central inferential result, but does not resolve how the family of secondary outcomes was handled. The secondary findings should be treated as supporting or descriptive evidence unless further analysis documentation clarifies their role and the multiplicity plan.

Missing-data handling is also not reported in the registry record. The listed arm sizes describe the participants associated with the outcome summaries, but the record does not explain whether every randomized participant had an observed week 16 outcome, how missing assessments were treated, or whether any imputation or sensitivity analyses were used. Those choices can affect estimates, especially when missingness differs between arms or relates to outcomes.

Analysis population definitions are not reported in the registry record. It is not clear from the available information whether the primary analysis followed an intention-to-treat principle, used another population, or applied particular exclusions. The statistical analysis plan, treatment of protocol deviations, and details of any covariate adjustments are also not reported. These gaps limit independent reproduction and make it difficult to assess how robust the findings are to alternative analysis choices.

16. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: appendicitis (1.5%), post procedural infection (1.5%), adenocarcinoma of colon (1.5%), metastases to lung (1.5%), dizziness (1.5%).

Serious adverse events affected 1 of 66 participants in the matching-placebo group and 3 of 67 participants in the Dupilumab Q2W group. The registry record lists zero deaths in each group. These counts describe serious adverse events during the recorded study period; they do not by themselves establish whether an event was caused by study treatment.

The record also lists other adverse events affecting 34 participants in the placebo group and 33 in the dupilumab group. These are distinct summaries from the serious adverse event counts. Six serious-event terms are listed at 1.5% each: appendicitis, post procedural infection, adenocarcinoma of colon, metastases to lung, dizziness, and syncope. The record does not specify in this listing which arm each term belongs to, or provide further detail on timing, severity, or relatedness.

These figures are descriptive and involve relatively small counts. They should be read as the registry's reported safety summary, not as a complete assessment of comparative risk. Further detail on event definitions, exposure time, and causal assessment is not reported in the registry record.

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

The results describe a randomized comparison of dupilumab and matching placebo in adults and adolescents with moderate-to-severe atopic hand and foot dermatitis. For the primary endpoint, the posted percentage meeting the IGA 0-or-1 threshold at week 16 was higher in the dupilumab arm than in the placebo arm. The recalculated risk difference is 0.236, with a 95% confidence interval from 0.088 to 0.384, and the sponsor reported p =0.003 from a Cochran-Mantel-Haenszel superiority analysis.

This is evidence about one defined endpoint at one assessment time in the participants enrolled in this trial. It does not describe every symptom, functional effect, or experience of the condition. Secondary outcomes cover some additional domains, but the registry record does not report a multiplicity plan or complete sponsor analyses across those outcomes.

The result does not establish the effect for every person with hand and foot dermatitis, nor does it show what happens beyond the reported follow-up. Generalizability depends on how closely other populations and care settings resemble the studied participants and trial conditions; details needed to assess that fully are not reported in the registry record.

The safety counts are also limited summaries. Serious adverse events and deaths are reported, but the record does not provide the full detail needed to assess event timing, relationship to treatment, or comparative risk with precision. Statistical evidence from the primary endpoint and descriptive safety counts do not, on their own, constitute medical advice or determine an individual treatment choice.

18. Why This Trial Matters Statistically

This trial illustrates how a clearly defined binary endpoint can be expressed in both arm-specific percentages and an arm contrast. The percentages show how often participants reached the IGA threshold; the risk difference and its confidence interval describe the size and precision of the contrast. Considering both the endpoint rates and the interval is more informative than relying on a p-value alone.

The study also shows why analysis methods matter. The sponsor's primary result comes from a Cochran-Mantel-Haenszel analysis, whereas the recalculation uses only the posted summary statistics and is unadjusted. Keeping those results distinct avoids presenting a simple reconstruction as though it were the full trial analysis. The continuous pain result provides a separate example of how mean changes, standard errors, and mean differences summarize a different type of outcome.

Finally, a broad set of secondary outcomes can help characterize whether results extend across related domains, but it also raises multiplicity and reporting questions. The registry record does not describe the strategy for handling multiple outcomes, missing data, or analysis populations. Those absences demonstrate why effect estimates, design context, and analysis documentation all matter when interpreting clinical-trial results.

19. 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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The registry record is a limited source for evaluating the conduct and analysis of this trial. It gives the broad design, treatment schedules, primary endpoint, and selected outcome results, but does not report the original sample-size justification, randomization procedures, stratification factors, or a full statistical analysis plan. The registry record also does not explain the roles covered by quadruple masking.

Key analysis details are not reported in the registry record, including missing-data methods, analysis population definitions, and the handling of protocol deviations. The primary sponsor analysis is reported as a p-value without a sponsor effect estimate or confidence interval. The unadjusted recalculation is informative about the arm summaries, but cannot recover unreported model details.

The registry lists many secondary measures, yet sponsor analyses are absent for most of the secondary outcomes. Multiplicity handling is not reported, which limits the confirmatory interpretation of secondary results. The reported outcomes also span different domains and measurement types, so an overall pattern should not be mistaken for one unified endpoint.

The safety information is summarized as counts and selected event terms. More detail on event timing, relatedness, duration, and exposure is not reported in the registry record. The posted data therefore support a focused statistical description, but not a complete reconstruction of trial conduct, all uncertainty sources, or the full clinical context.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT) — NCT04417894.
• Registry record last updated 2023-12-22; status last verified 2023-12.
• Results first posted 2023-12-22.
• 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.

23. Record Summary

NCT04417894 is a completed phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of dupilumab in adults and adolescents with moderate-to-severe atopic hand and foot dermatitis. Enrollment was 133. The primary endpoint was the percentage with IGA 0 or 1 at week 16.

The posted primary results were 40.3% for Dupilumab Q2W and 16.7% for matching placebo. The unadjusted recalculated risk difference was 0.236, with a 95% confidence interval from 0.088 to 0.384. The sponsor reported a Cochran-Mantel-Haenszel superiority analysis with p =0.003.

The record also lists secondary outcomes and safety summaries. Details of the original sample-size rationale, multiplicity strategy, missing-data handling, and analysis populations are not reported in the registry record.