Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT) (NCT03531957), a randomized phase 2 study. The primary outcome is Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12.

2. Clinical Question

The trial also recorded secondary measures covering response on EASI, itch, SCORAD, investigator-rated status, patient-reported eczema symptoms, dermatology-related quality of life, and body surface area. These outcomes provide different views of disease severity and patient experience, but they do not replace the prespecified primary question. The registry record does not report a formal analysis plan or explain how the multiple dose comparisons and secondary outcomes were handled statistically. The interpretation therefore distinguishes descriptive group summaries from unadjusted comparisons recalculated from the posted summary statistics.

3. Trial Design

RADIANT was a randomized, double-blind, placebo-controlled Phase 2B study of ASN002 in subjects with moderate to severe atopic dermatitis. The registry record identifies the allocation as randomized, the masking as quadruple, and the model as parallel. Participants were assigned to one of three ASN002 dose groups or to a matching placebo oral tablet. The posted arm summaries include 40 mg, 60 mg, and 80 mg ASN002, alongside placebo.

The registry record lists enrollment as 244 and the study status as completed. The study start date is 2018-07-05, and the primary completion date is 2019-07-22. These record dates describe the study timeline; they do not establish when every participant completed follow-up or when each analysis was performed.

The primary outcome was mean change from baseline in EASI at Week 12, assessed in the mITT population. The registry record describes the outcome as a mean with standard deviation. It also lists secondary outcomes for EASI75, itch on the 5-D Pruritus Scale, percent change in SCORAD, investigator global assessment response, POEM, DLQI, and BSA. Numerical secondary summaries are posted for EASI75, itch, and SCORAD; the registry record does not report numerical summaries for the other listed secondary outcomes in the record.

The record does not report the original sample-size justification, the allocation ratio planned by the protocol, detailed eligibility criteria, treatment duration beyond the primary endpoint timeframe, or the statistical analysis plan. Those details should not be inferred from the arm sizes or from the planning illustrations based on observed effects. The registry record identifies Asana BioSciences as sponsor.

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

Analysis population for the primary outcome, as defined in the registry: mITT

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 Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12, measured over Week 12.

The primary endpoint is change from baseline in the Eczema Area and Severity Index (EASI) at Week 12. EASI combines assessments of erythema, induration or infiltration, excoriation, and lichenification across four body regions. The scoring also accounts for the percentage of body surface area affected in each region and that region’s share of the whole body. The composite score ranges from 0 to 72, with higher values indicating worse disease.

Change from baseline expresses how the score at follow-up differs from the participant’s starting score. In the posted group means, negative values indicate reductions in EASI. The primary result is a comparison of average change in each ASN002 group with average change in the placebo group, rather than a comparison of endpoint scores alone. This makes the endpoint responsive to improvement or worsening relative to baseline, while the placebo comparison provides context for changes that also occur in the control group.

EASI is used as a structured measure because it combines several clinician-assessed signs with the extent of affected body area. Its composite nature can capture changes across more than one aspect of disease severity, but it also means the average score does not show which component drove a group’s change. Nor does a group mean describe every participant’s experience. The registry record reports the primary outcome as a mean and standard deviation for the mITT population. It does not report participant-level distributions, baseline EASI values, or details of the endpoint scoring procedures beyond the stated description.

As a general statistical point, a continuous endpoint retains information about the magnitude of score changes rather than reducing every participant to a responder or non-responder category. The interpretation still depends on the scale, the analysis population, the handling of missing observations, and the precision of the comparison. The registry record does not report a threshold for a clinically important EASI change.

7. Results Posted in the Registry

• ASN002 40 mg: mean -15.80 versus -13.10 on control; difference -2.70 (95% CI -6.76 to 1.36), standardized effect d = -0.24; z-test p = 0.192.
• ASN002 60 mg: mean -15.80 versus -13.10 on control; difference -2.70 (95% CI -6.61 to 1.21), standardized effect d = -0.25; z-test p = 0.176.
• ASN002 80 mg: mean -17.50 versus -13.10 on control; difference -4.40 (95% CI -8.55 to -0.25), standardized effect d = -0.38; z-test p = 0.038.

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.

Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75)

• 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:
  • ASN002 40 mg: 49.2% (30/61) versus 38.3% (23/60) on control; risk difference 10.8 percentage points (95% CI -6.7 to 28.4), risk ratio 1.28 (0.85–1.93); unadjusted two-proportion z-test p = 0.229.
  • ASN002 60 mg: 49.2% (29/59) versus 38.3% (23/60) on control; risk difference 10.8 percentage points (95% CI -6.9 to 28.5), risk ratio 1.28 (0.85–1.94); unadjusted two-proportion z-test p = 0.234.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN002 40 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN002 60 mg and the control. The interval gives the range of effects that remain compatible with the data.

Change From Baseline in 5-D Pruritus (Itching) Scale

• 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 deviations.
• Result:
  • ASN002 40 mg: mean -6.60 versus -5.10 on control; difference -1.50 (95% CI -3.24 to 0.24), standardized effect d = -0.31; z-test p = 0.092.
  • ASN002 60 mg: mean -6.70 versus -5.10 on control; difference -1.60 (95% CI -3.21 to 0.01), standardized effect d = -0.36; z-test p = 0.051.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN002 40 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN002 60 mg and the control. The interval gives the range of effects that remain compatible with the data.

Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)

• 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 deviations.
• Result:
  • ASN002 40 mg: mean -45.00 versus -38.50 on control; difference -6.50 (95% CI -18.17 to 5.17), standardized effect d = -0.20; z-test p = 0.275.
  • ASN002 60 mg: mean -47.30 versus -38.50 on control; difference -8.80 (95% CI -19.60 to 2.00), standardized effect d = -0.29; z-test p = 0.110.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN002 40 mg and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN002 60 mg and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the picture beyond the primary EASI mean change. They include a threshold-based EASI response, an itch measure, SCORAD, investigator global assessment, patient-reported eczema symptoms, dermatology-related quality of life, and body surface area. These measures reflect different aspects of disease severity and experience, so they need not move in lockstep with the primary score. Numerical group summaries and unadjusted comparisons are posted for EASI75, itch, and SCORAD; the registry record does not report numerical summaries for the other named outcomes.

Across the posted secondary summaries, the group means or response percentages generally appear more favorable for the ASN002 groups than for placebo, but the unadjusted recalculated comparisons are not uniformly decisive. This broad pattern is directionally consistent with the primary group means, while offering no independent confirmation that the primary finding is robust. The secondary outcomes use different scales and estimands, so they should not be collapsed into a single overall effect or treated as interchangeable measures.

Secondary results carry less weight when many outcomes and dose comparisons are examined without a reported multiplicity plan. As a general statistical point, multiple testing increases the chance that at least one result will look unusual even when there is no underlying difference. A secondary result can be informative, but its evidential strength depends on whether it was prespecified, how missing data were handled, and whether the analysis accounted for the full set of comparisons. Those details are not reported in the registry record.

Some outcomes are binary and some are continuous. Dichotomizing a score into responder status can make results easier to interpret, but it discards information about how far participants’ scores changed and makes findings depend on the selected threshold. Continuous measures retain magnitude but may be less directly intuitive. The secondary outcomes can therefore provide complementary context, but none should be used alone to override the primary result or to imply a consistent effect across every domain.

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

• Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75)
• Change From Baseline in 5-D Pruritus (Itching) Scale
• Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD)
• Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1
• Change From Baseline in Patient-Oriented Eczema Measure (POEM)
• Change From Baseline in Dermatology Life Quality Index (DLQI)
• Change From Baseline in Body Surface Area (BSA)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a change in EASI score, and the registry record reports group means and standard deviations. A mean summarizes the average change in a group. A standard deviation describes how dispersed individual changes are around that average. Neither quantity alone describes the full distribution, and an average difference is not the same as the proportion of participants who crossed a response threshold.

What does the mean difference represent?

For each dose, the recalculated comparison is the ASN002 group’s posted mean change minus the placebo group’s posted mean change. A negative estimate means the ASN002 group’s average change was more negative than the placebo group’s average change on this scale. Because lower EASI scores indicate less severe disease, that direction corresponds to a larger average reduction. This interpretation describes the comparison’s direction; it does not establish its clinical importance.

The recalculated estimates use the posted group means and standard deviations without adjustment for baseline characteristics or other covariates. They are simple unadjusted recalculations, rather than results from an analysis model reported by the sponsor. The registry record does not report the sponsor’s inferential model, its assumptions, or adjusted estimates. There is no discrepancy flag in the registry record, but the recalculations still should not be presented as a substitute for a sponsor analysis that is not reported there.

How should the confidence interval be read?

A confidence interval expresses uncertainty around an estimated difference under the assumptions of the method used. An interval that includes zero is compatible with no average difference as well as with differences in either direction within the interval. An interval that excludes zero indicates that zero is outside that interval, but does not by itself address clinical importance, bias, or multiplicity. The intervals for the primary comparisons are unadjusted and should be interpreted alongside the design and the missing analysis details.

The standard errors in the posted comparison calculations are based on the within-group standard deviations and the group sizes. In general, standard errors quantify the sampling uncertainty of estimates: smaller standard errors tend to yield narrower confidence intervals, all else being equal. The posted group sizes are modest, so individual observations can influence summaries more than they would in a much larger study. That is a general consideration, not evidence that any particular observation did influence these results.

What do the p-values say?

The unadjusted p-value measures how incompatible the observed comparison is with a specified null hypothesis of no difference, under the statistical method’s assumptions. It is not the probability that the null hypothesis is true, nor the probability that the result is due to chance. A p-value also does not measure the size or importance of an effect. Here the p-values are unadjusted recalculations, and the record does not report whether or how the trial’s planned analysis adjusted for the three dose-versus-placebo comparisons or for secondary outcomes.

For binary outcomes such as EASI75, the registry provides group percentages and recalculated risk differences, as well as relative measures. A risk difference describes the contrast in response proportions on an absolute scale. A relative risk compares proportions as a ratio, while an odds ratio compares odds. These measures answer related but distinct questions. The EASI75 comparisons are unadjusted, and the record does not list reported analyses for them. For continuous secondary measures such as itch and SCORAD, the posted recalculations compare group mean changes or percentage changes; these estimates likewise do not reflect a reported adjusted analysis.

Why can multiplicity matter?

Testing several doses against one control and examining multiple outcomes creates multiple opportunities for apparently unusual results. As a general statistical principle, a multiplicity procedure may control the overall chance of false-positive findings across a family of tests, but it can also affect intervals and p-values. The registry record does not report a multiplicity strategy, so the posted unadjusted comparisons should not be treated as if such a procedure had been applied. The primary endpoint should be distinguished from exploratory or secondary comparisons, especially when evaluating isolated p-values.

Statistical inference also depends on analysis population and missing-data handling. The registry record names mITT for the primary outcome but does not define membership, give numbers analyzed by endpoint, or explain any imputation or other missing-data method. As a general matter, missingness can affect a comparison if the participants with observed outcomes differ systematically from those without observed outcomes. The record does not provide enough detail to assess that possibility. These limitations constrain how confidently the recalculations can represent the trial’s intended analysis.

11. Confidence Intervals and Precision

The 95% confidence intervals around the primary mean differences show that the estimates are not equally precise. For ASN002 40 mg versus placebo, the recalculated difference was -2.7, with a 95% confidence interval from -6.759 to 1.359. For 60 mg versus placebo, the difference was -2.7, with an interval from -6.611 to 1.211. Each interval spans zero, so the corresponding results are compatible with no average difference as well as with a more negative mean change in the ASN002 group. They also include values on the other side of zero.

For ASN002 80 mg versus placebo, the recalculated difference was -4.4, with a 95% confidence interval from -8.55 to -0.250. This interval lies below zero, but it still covers a range of possible differences. Its lower and upper limits indicate that the estimate is not known with exactness. An interval excluding zero is not, on its own, evidence that an effect is clinically important or that the result would remain similar after accounting for multiple comparisons.

As a general explanation, a confidence interval gives a range of values compatible with the observed data and the assumptions used to calculate it. It is not a range containing most individual participants’ outcomes, and it does not express certainty about the result in isolation. The posted intervals are based on unadjusted recalculations from group summary statistics. The registry record does not report intervals from the sponsor’s planned model, nor does it report a multiplicity-adjusted interval.

The group standard deviations show that changes varied within each arm. Variation within groups, the number analyzed, and the size of the estimated difference all contribute to precision. The registry record does not include participant-level results, so it is not possible to examine skew, outliers, or subgroup patterns from these summaries. The estimates should therefore be read as group-level findings with uncertainty, rather than as precise predictions for individuals.

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 planning figures describe hypothetical future studies based on observed effects; they are not the original design assumptions for RADIANT. For these continuous endpoints, the values are participants per arm, not total participants. The planning illustration assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It scales the effect to detect to the stated fraction of the observed effect. The trial’s own original sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the specified effect if that effect were the true effect and the planning assumptions held. The 90% power column uses a higher target chance of detection under the same stated assumptions. These are design calculations for hypothetical studies, not a measure of how likely the trial’s observed result is to be true.

Each row uses a different fraction of the observed effect: 100%, 75%, or 50%. Smaller effects are harder to distinguish from random variation, so the illustration generally requires more participants per arm when planning for a smaller effect. For example, for the 80 mg primary comparison, the listed participants per arm for 80% power are 112 when planning for 100% of the observed effect, 199 for 75%, and 447 for 50%. These figures are illustrations, not recommendations or a reconstruction of the study’s protocol.

This is not observed power. Observed power calculated from the result after a study is complete does not add useful information beyond the estimate and its uncertainty. The planning figures are most useful for illustrating how sensitive design requirements can be to the effect assumed. They do not establish that the trial was adequately or inadequately sized, because its original target effect, planned analysis, and sample-size justification are not reported in the registry record.

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, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -2.700; pooled standard deviation σ = 11.382.
2. n = 2 × (1.96 + 0.842)² × 11.382² / -2.700² = 278.9, rounded up to 279 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
delta <- -2.7                      # observed difference in means
sigma <- 11.3816087460015                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^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 (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3531957)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 279 (80% power), 374 (90% power)
 75% of observed effect: n per arm = 496 (80% power), 664 (90% power)
 50% of observed effect: n per arm = 1,116 (80% power), 1,494 (90% power)
power.t.test: 279.9 
Simulated power at n = 279 per arm: 0.795 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-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. Multiplicity, Missing Data and Analysis Populations

The registry record does not report the statistical analysis plan, the number of planned hypothesis tests, or a multiplicity procedure. The primary endpoint compares three ASN002 dose groups with placebo, and the record also identifies several secondary outcomes. Examining multiple comparisons increases the chance that at least one unadjusted result will appear statistically notable by chance. This is a general property of repeated testing. Without a stated hierarchy or adjustment method, the unadjusted p-values and intervals should be viewed as nominal rather than as control of the overall error rate across all trial questions.

The record lists the primary analysis population as mITT, but does not define the term, describe inclusion or exclusion rules, or report the number analyzed by endpoint. It does not explain whether participants were analyzed according to assigned group, whether anyone was excluded after randomization, or how protocol deviations were handled. These details are not reported in the registry record and should not be inferred from the arm summaries.

Handling of missing outcome data is also not reported. The record does not describe the amount or pattern of missing Week 12 EASI data, whether missing values were imputed, or whether sensitivity analyses were conducted. In general, complete-case summaries can be biased if missingness is related to outcome or treatment experience; different assumptions about missing values can lead to different estimates. This is a methodological concern, not a claim that the posted results are biased.

The registry record does not report interim analyses, stopping rules, adjusted models, covariates, or the original sample-size justification. It records zero reported analyses for the primary outcome, and no reported analyses for the posted secondary comparisons. Therefore, the recalculated comparisons are useful descriptive checks on the posted summary statistics, but they cannot supply the missing protocol details or establish that the trial’s planned analysis was carried out in a particular way. The absence of those details limits assessment of prespecification, robustness, and the extent to which nominal findings should be treated as confirmatory.

15. 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: pneumonia (1.6%), pyrexia (1.6%), dysarthria (1.6%), arthralgia (1.6%), seizure (1.6%).

The registry record reports participants affected by serious adverse events and participants affected by other adverse events separately. For serious adverse events, the reported figures are 4 in ASN002 40 mg, 0 in ASN002 60 mg, 2 in ASN002 80 mg, and 0 in placebo. For other adverse events, the reported figures are 20, 19, 24, and 9, respectively. The corresponding groups at risk are recorded as 61, 59, 63, and 60. No deaths are reported in any group.

These figures are counts of participants affected, not a complete description of event duration, severity, timing, recurrence, or relationship to study treatment. The registry record lists serious adverse event terms with a reported frequency of 1.6% for pneumonia, pyrexia, dysarthria, arthralgia, seizure, and staphylococcal bacteremia. It does not give enough detail in this record to assign each listed term to a dose group or to interpret the clinical course.

Safety counts are descriptive. Differences in counts do not by themselves establish causation or quantify comparative risk, particularly without details on exposure time, event definitions, ascertainment, and analysis. The registry record does not report a formal comparative safety analysis or a complete narrative of adverse events. These numbers should be read as the recorded counts, not as a prediction of safety for an individual or other population.

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

The posted results describe average changes and adverse-event counts among participants in this randomized Phase 2B study. They do not establish what any individual participant would experience. The primary endpoint is a group-level EASI change at Week 12, and the recalculated comparisons indicate how the posted group means differ from the placebo mean under a simple unadjusted calculation.

The estimates for the ASN002 dose groups are more negative than the placebo estimate, with the 80 mg comparison’s unadjusted interval excluding zero while the intervals for the 40 mg and 60 mg comparisons include zero. That pattern is a statistical description, not a definitive conclusion about the treatment’s effect. The record does not report the sponsor’s inferential analysis, its multiplicity handling, or key details about missing data and the mITT population. The uncertainty in the estimates and these reporting gaps should remain part of any interpretation.

A statistically notable unadjusted comparison does not automatically indicate a clinically important difference. The registry record does not report a threshold for meaningful change in EASI, and an average difference does not tell how many participants experienced a particular level of improvement. The posted secondary outcomes add context but do not establish that every measure or dose showed a consistent effect.

Nor do the results establish long-term effects, effects in populations beyond those studied, or the balance of benefits and harms in settings not represented by this trial. The primary endpoint is at Week 12, and the record does not provide longer-term efficacy results. Safety counts are descriptive, and no deaths are reported; these observations alone cannot rule out uncommon events or determine causality.

The trial’s randomized, placebo-controlled design is relevant to comparing groups, but the registry record’s limited analysis detail prevents a full assessment of the planned statistical approach. The most defensible reading is therefore restricted to the posted summaries and their uncertainty. They support neither individualized predictions nor medical advice.

17. Why This Trial Matters Statistically

This study illustrates why a trial result should be read through its estimand, comparison, and uncertainty rather than through a single p-value. The primary endpoint is continuous EASI change, and the reported group means show reductions in all arms. The key statistical question is not whether scores changed within each arm, but how the changes compare between each ASN002 dose and placebo. The recalculated differences and confidence intervals make that contrast explicit.

The dose groups also demonstrate why an apparent ordering of estimates should not be overinterpreted. The 40 mg and 60 mg mean changes are the same in the posted summaries, while the 80 mg estimate is more negative. Such observed values can motivate further questions, but a formal dose-response conclusion would require an analysis designed to test that pattern. The registry record does not report such a test.

The study also shows the importance of separating registered outcome descriptions from analysis evidence. The record identifies an mITT population and multiple secondary outcomes but does not provide the details needed to reconstruct the planned inferential strategy. Recalculated comparisons can help readers understand posted summary data, while the absence of a reported model, multiplicity approach, and missing-data methods limits confirmatory interpretation.

Finally, the planning illustrations make clear that sample-size requirements depend on assumptions about the effect worth detecting. Planning around a smaller effect generally requires more participants per arm. These calculations should not be confused with the trial’s own design justification or with observed power. Together, the primary estimate, its interval, the multiplicity context, and the reporting gaps provide a more useful statistical reading than any one statistic in isolation.

18. 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.

Several trial-specific limitations restrict interpretation of the posted results. The primary outcome is reported for the mITT population, but the registry record does not define that population or state how many participants contributed data to each analysis. Although arm sizes are posted, they do not resolve which participants were included in the endpoint summaries or how missing observations were handled.

The record does not report baseline EASI values, adjusted treatment estimates, covariates, or the sponsor’s inferential model. The recalculated mean differences use only posted group summaries and are unadjusted. They may not match an analysis that accounts for baseline scores, stratification, or other design features. No such features should be assumed because they are not reported in the registry record.

Multiplicity is a further limitation. There are three dose-versus-placebo comparisons for the primary outcome and several registered secondary outcomes, but no adjustment procedure or testing hierarchy is reported. The unadjusted p-values therefore do not establish that the overall set of comparisons controls false-positive risk. The record also does not report a formal dose-response analysis.

The posted numerical secondary summaries cover only some of the named outcomes, and the record does not report numerical findings for investigator global assessment, POEM, DLQI, or BSA. This limits evaluation of whether the pattern extends across clinician-rated and participant-reported domains. For safety, counts are available, but the record does not provide detailed timing, duration, exposure-adjusted rates, or causal assessment.

Finally, the primary outcome timeframe is Week 12. The record does not provide longer-term efficacy results or a threshold for clinically important EASI change. These limitations do not prove that the estimates are biased or uninformative; they define what can and cannot be concluded from the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Phase 2B Study to Evaluate ASN002 in Subjects With Moderate to Severe Atopic Dermatitis (RADIANT) — NCT03531957.
• Registry record last updated 2023-07-03; status last verified 2023-06.
• Results first posted 2022-11-15.
• 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.

22. Record Summary

RADIANT was a completed, randomized, quadruple-masked, parallel Phase 2B, placebo-controlled study sponsored by Asana BioSciences. It enrolled subjects with moderate to severe atopic dermatitis and compared ASN002 40 mg, 60 mg, and 80 mg with a matching placebo oral tablet. The primary endpoint was mean change from baseline in EASI at Week 12 in the mITT population.

The posted mean EASI changes were -15.8 for 40 mg, -15.8 for 60 mg, -17.5 for 80 mg, and -13.1 for placebo. Unadjusted recalculated mean differences versus placebo were -2.7, -2.7, and -4.4, respectively. The registry record does not report the sponsor’s inferential analysis, the original sample-size justification, multiplicity handling, or missing-data methods. Secondary outcomes and safety counts provide additional descriptive context, but require the same caution about analysis details and uncertainty.