A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis (NCT05084963), a randomized phase 2 study. The primary outcome is Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean).

2. Clinical Question

3. Trial Design

This was a Phase 2a, randomized, quadruple-masked, parallel-group, placebo-controlled, multicenter study sponsored by Revolo Biotherapeutics. The registry record lists the study as completed. It began on 2021-10-29 and had primary completion on 2022-10-24. The official title describes a study of efficacy, safety, and tolerability in adult participants with active EoE.

The three listed groups were IRL201104 4 mg, IRL201104 8 mg, and placebo. Each was administered intravenously on Days 0, 7, and 14. Total enrollment was 36. For the primary endpoint, the posted group results each include 12 participants, and the stated analysis population is the Full Analysis Set. The registry record does not report further details about how participants were randomized, the masking procedures, or the exact contents of that analysis population.

The primary endpoint was assessed at 4 weeks and summarized as mean change from baseline in peak esophageal intraepithelial eosinophil count, with standard deviation. Listed secondary outcomes include symptom score change, a Week 4 threshold for peak eosinophil count, percent change in the count, treatment-emergent adverse events, and safety laboratory measures. Numeric results are not posted for every listed secondary outcome. The registry record does not report the original sample-size justification, a detailed statistical analysis plan, or whether interim analyses were planned or conducted.

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

Reasons for not completing this period:

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

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Safety Analysis Set (SAS) - includes all participants who were documented to have taken at least 1 dose of study treatment. Safety evaluations considered participants according to the actual treatment they received. (Note: One participant was randomised to Dose A but received Dose B for all 3 doses due to an error at the clinical site. The participant is considered under Dose A in the Full Analysis Set (FAS) as 'Randomized' and counted under Dose B in the SAS as 'Treated').

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in the Peak Esophageal Intraepithelial Eosinophil Count at Week 4 (Mean), measured over 4 weeks.

The primary endpoint is the change from baseline to Week 4 in peak esophageal intraepithelial eosinophil count, measured as eosinophil count per high power field. It is a histologic measure: it describes eosinophils observed in esophageal tissue rather than a symptom score. The registry record says the change in each treatment group was to be summarized by its mean and standard deviation, and identifies the Full Analysis Set as the analysis population.

A change measure describes how the count at follow-up differs from the baseline count. The posted group means are -9.2 for IRL201104 4 mg, -31.6 for IRL201104 8 mg, and -7.8 for placebo. In this measure, negative values represent decreases from baseline. The standard deviations—87.95, 68.09, and 104.0, respectively—describe substantial dispersion of individual changes around each group mean.

Histologic and symptom outcomes answer different questions. A tissue count describes an observed biological feature, while the listed Dysphagia Symptom Questionnaire outcome concerns symptoms. Neither measure alone captures every aspect of the condition or the study experience. The registry record does not report a rationale for choosing this endpoint over the other listed outcomes, nor does it report a threshold defining a clinically important change. The endpoint can therefore be read as a quantitative group-level measure, but the posted record does not establish what magnitude of change would be meaningful to participants.

7. Results Posted in the Registry

• Arm 1: IRL201104 4 mg: mean -9.20 versus -7.80 on control; difference -1.40 (95% CI -78.47 to 75.67), standardized effect d = -0.01; z-test p = 0.972.
• Arm 2: IRL201104 8 mg: mean -31.60 versus -7.80 on control; difference -23.80 (95% CI -94.14 to 46.54), standardized effect d = -0.27; z-test p = 0.507.

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 Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Arm 1: IRL201104 4 mg: 0.0% (0/12) versus 8.3% (1/12) on control; risk difference -8.3 percentage points (95% CI -24.0 to 7.3); unadjusted two-proportion z-test p = 0.307.
  • Arm 2: IRL201104 8 mg: 8.3% (1/12) versus 8.3% (1/12) on control; risk difference 0.0 percentage points (95% CI -22.1 to 22.1), risk ratio 1.00 (0.07–14.21); unadjusted two-proportion z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 1: IRL201104 4 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 Arm 2: IRL201104 8 mg and the control. The interval gives the range of effects that remain compatible with the data.

Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf)

• 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:
  • Arm 1: IRL201104 4 mg: mean 31.06 versus 44.31 on control; difference -13.24 (95% CI -134.62 to 108.13), standardized effect d = -0.09; z-test p = 0.831.
  • Arm 2: IRL201104 8 mg: mean -19.01 versus 44.31 on control; difference -63.31 (95% CI -177.27 to 50.64), standardized effect d = -0.44; z-test p = 0.276.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 1: IRL201104 4 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 Arm 2: IRL201104 8 mg and the control. The interval gives the range of effects that remain compatible with the data.

The registry record lists secondary outcomes covering symptoms, a Week 4 eosinophil-count threshold, percent change in peak count, treatment-emergent adverse events, and safety laboratory measures. Numeric results are posted for the threshold and percent-change outcomes, but the registry record does not report numeric results for all listed secondary measures. In particular, the Dysphagia Symptom Questionnaire outcome is listed, while its result is not reported in the registry record. The available secondary findings therefore do not constitute a complete picture across symptoms, tissue measures, and safety assessments.

The threshold outcome records 0 participants in the 4 mg group and 1 participant in each of the 8 mg and placebo groups meeting the stated Week 4 threshold. Its recalculated comparisons are unadjusted and imprecise. The percent-change means are 31.06 for 4 mg, -19.01 for 8 mg, and 44.31 for placebo, with standard deviations of 83.86, 39.72, and 197.4, respectively. These outcomes use different summaries and scales from the primary endpoint. Their pattern should not be collapsed into a single overall direction or treated as a direct replication of the primary measure.

Secondary outcomes can help describe a study across distinct domains, but each comparison adds another opportunity for a chance finding. General statistical principle: when many outcomes or contrasts are examined, unadjusted p values do not control the overall chance of false-positive conclusions across all those tests. The registry record does not report a multiplicity strategy or identify a hierarchy for interpreting secondary outcomes. Consequently, isolated secondary results carry less weight than a prespecified primary analysis, particularly when the available groups are small and intervals are broad.

The secondary findings do not resolve the uncertainty in the primary comparison. Nor can absent results be treated as neutral or assumed to match the reported outcomes. The registry record does not report results for several listed secondary endpoints, so they cannot be used to corroborate or contradict the primary result. The proper reading is limited to the outcomes and estimates that are actually posted, with caution about multiple comparisons and incomplete outcome reporting.

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

• Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Score From Baseline.
• Percent of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of < 15 Eos/Hpf (Week 4)
• Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf)
• Treatment Emergent Adverse Events (TEAE)
• Safety Laboratory Data: Biochemistry
• Safety Laboratory Data: Coagulation
• Safety Laboratory Data: Hematology Panel
• Safety Laboratory Data: Urinalysis Panel

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant has a change in eosinophil count, and the registry reports a mean and standard deviation for each group. A mean describes the center of the observed values. It gives a concise group summary, but it can conceal differences in the spread or shape of the individual results. The standard deviation describes how dispersed participant-level values are around the mean. It is not the uncertainty of the mean itself and is not a confidence interval.

What does a group difference describe?

The recalculated comparisons subtract the placebo group mean from the corresponding IRL201104 group mean. For the primary measure, the resulting mean differences are -1.4 for IRL201104 4 mg and -23.8 for IRL201104 8 mg. A negative difference means that the active-group mean change is more negative than the placebo mean change, on the reported change scale. It does not by itself establish that the difference is reliable, important to patients, or caused by treatment.

These comparisons are unadjusted. They use the posted summary statistics rather than a model that adjusts for baseline values or other participant characteristics. The registry record does not report adjusted primary comparisons, the specific model used for sponsor analyses, or a detailed statistical analysis plan. The record lists no sponsor-reported analyses for the posted secondary results, and its analysis count is 0. Accordingly, the comparisons are recalculated summaries, not claims about the sponsor’s prespecified inferential analysis.

How should the confidence interval be read?

A confidence interval expresses uncertainty around an estimated group difference under the method used to calculate it. A narrower interval indicates greater precision; a wider interval indicates that a broad range of differences remains compatible with the data and method. The primary comparison intervals extend from -78.47 to 75.67 for 4 mg and from -94.14 to 46.54 for 8 mg. Both include zero, the value corresponding to no difference in group means. Their width reflects limited precision, so the point estimates should not be read in isolation.

A p value is another summary of the data relative to a null comparison under a statistical model. The recalculated unadjusted values are 0.972 for 4 mg and 0.507 for 8 mg. A p value is not the probability that a treatment effect is true, nor does it quantify the size or clinical importance of a difference. The registry record does not report whether its own analysis used the same test or adjustment choices as these recalculations.

Why does variability matter?

The group standard deviations for the primary endpoint are large compared with the mean differences. This signals that participant changes are dispersed relative to the observed separation between group averages. General statistical principle: greater variability makes it harder to estimate a group mean precisely and to distinguish a group difference from random variation, unless there is sufficient information from participants. When data are highly dispersed or skewed, a mean and standard deviation may also give an incomplete description of the outcome distribution. The registry record does not provide individual-level values or distribution plots, so the shape of the primary outcome cannot be assessed from the posted summaries alone.

Over-dispersion is a general concern when the observed spread in data exceeds what a chosen statistical model assumes. It can make standard errors and inferential results unreliable if the model does not accommodate the extra variability. The registry record does not report a count-data model for the continuous change endpoint, nor does it provide enough detail to determine whether over-dispersion was assessed. This is a general methodological consideration, not a claim that a particular model was used or violated in this study.

What do the binary secondary results add?

The Week 4 threshold outcome is a participant count: the posted values are 0 for IRL201104 4 mg, 1 for IRL201104 8 mg, and 1 for placebo. Recalculated risk differences compare the proportion reaching the threshold between an active group and placebo. The small counts make those estimates uncertain. The record lists a recalculated risk difference of -0.083 for the 4 mg comparison, with a 95% confidence interval from -0.240 to 0.073 and p = 0.307. For 8 mg, the difference is 0.0, with a 95% confidence interval from -0.221 to 0.221 and p = 1.0. These are unadjusted comparisons, and no sponsor-reported analyses are listed for this outcome.

In general, binary outcomes with few events can yield unstable estimates, and confidence intervals can be broad. A risk difference states the contrast in proportions on an absolute scale; it does not describe the continuous change in eosinophil count. The record also lists relative effect measures for one comparison, but those estimates are highly uncertain and should not be used to replace the absolute count and interval. The outcome’s small counts and lack of a reported multiplicity plan further limit the weight of isolated secondary findings.

For the continuous secondary percent-change outcome, group means and standard deviations are posted, and recalculated differences with confidence intervals are available. Those calculations follow the same general reading principles as the primary continuous comparison: consider the scale, dispersion, interval width, and the distinction between an unadjusted estimate and a sponsor-reported analysis. The registry record does not report numeric results for every listed symptom or laboratory outcome, so no broader inference across those measures is possible.

11. Confidence Intervals and Precision

Precision concerns how narrowly the data locate a group difference. The primary estimates are not precise: the recalculated mean difference is -1.4 for IRL201104 4 mg versus placebo, with a 95% confidence interval from -78.47 to 75.67. For IRL201104 8 mg versus placebo, it is -23.8, with a 95% confidence interval from -94.14 to 46.54. Both intervals include zero and cover differences in either direction. The point estimates therefore do not tightly determine the size or direction of a population difference.

The intervals are broad in the context of the group means, and each primary group has 12 participants represented in the endpoint results. The standard deviations—87.95, 68.09, and 104.0—also show that participant-level changes were highly variable. Small groups combined with substantial variability generally yield less precise estimates. A confidence interval does not show the range containing most individual participant outcomes; it describes uncertainty about the estimated group contrast under its calculation method.

The secondary threshold comparisons are similarly uncertain. The 4 mg risk difference has a 95% confidence interval from -0.240 to 0.073, while the 8 mg interval runs from -0.221 to 0.221. These intervals are compatible with differences on either side of zero. The registry record does not report sponsor-calculated confidence intervals or detailed methods for the posted analyses, so these recalculated intervals should be understood as unadjusted statistical summaries rather than definitive study conclusions.

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 based on the observed effect, not the original design assumptions for this trial. The registry record does not report the study’s original sample-size justification or assumptions. The planning calculation uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; it evaluates effects set at 100%, 75%, or 50% of the observed effect. For these non-time-to-event comparisons, the figures are participants per arm, not total events.

The 80% power column describes the number of participants per arm estimated to give an 80% chance of detecting the specified effect if that effect were present, under the stated planning assumptions. The 90% column describes the corresponding target for a 90% chance. Higher planned power generally requires more participants. The calculations are displayed separately for each active-versus-placebo comparison, so their assumptions should not be mistaken for the allocation across the full three-group trial.

The effect sizes used in these illustrations come from observed group differences in a small study. Such estimates can be unstable, especially when the outcome is variable. Planning for a smaller fraction of the observed effect requires more participants per arm than planning for the full observed effect. The resulting figures are hypothetical design illustrations, not observed power, not the number actually enrolled, and not evidence that the study was designed with those targets. They should be read as sensitivity to effect size under the stated calculation assumptions, not as a recommendation for a future study.

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 = -1.400; pooled standard deviation σ = 96.321.
2. n = 2 × (1.96 + 0.842)² × 96.321² / -1.400² = 74,305.5, rounded up to 74,306 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 <- -1.4                      # observed difference in means
sigma <- 96.3207218100031                     # 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(5084963)
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 = 74,306 (80% power), 99,475 (90% power)
 75% of observed effect: n per arm = 132,099 (80% power), 176,843 (90% power)
 50% of observed effect: n per arm = 297,223 (80% power), 397,897 (90% power)
power.t.test: 74306.5 
Simulated power at n = 74,306 per arm: 0.798 (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 lists a primary outcome and multiple secondary outcomes, including more than one comparison between an active group and placebo. It does not report a multiplicity adjustment, a testing hierarchy, or a strategy for controlling the overall type I error across outcomes and comparisons. The p values described for the comparisons are unadjusted recalculations. They should therefore be interpreted as individual comparison summaries, not as results adjusted for the full family of analyses.

Multiplicity matters because examining many outcomes can increase the chance that at least one appears unusual by chance alone. General statistical principle: prespecifying a primary endpoint and a limited testing sequence can help distinguish confirmatory questions from exploratory ones. In the absence of a reported plan, it is not possible to determine which secondary comparisons, if any, were intended to support confirmatory claims. The record does not report interim analyses or stopping rules.

Missing-data methods are not reported in the registry record. The primary endpoint identifies the Full Analysis Set, but the record does not explain the inclusion criteria for that population, how missing baseline or Week 4 measurements were handled, whether any values were imputed, or how participants with incomplete follow-up were treated. Outcome counts shown for the primary endpoint are 12 per group, while safety groups at risk are listed as 11, 13, and 12. The record does not explain this difference, and it should not be interpreted as evidence about why participants were included or excluded.

The registry record does not report details of the statistical model or test used in the sponsor’s primary analysis, adjustments for baseline values, assumptions about the outcome distribution, or sensitivity analyses. It also does not provide a full account of protocol deviations or analysis-population definitions. These omissions limit the ability to assess whether the posted summaries represent the intended estimand and how robust conclusions might be to alternative analytic choices.

The original sample-size rationale and the assumptions underlying the trial’s own design are not reported in the registry record. The separate planning illustrations use observed effects and stated calculation assumptions; they cannot reconstruct the original design plan. Collectively, the missing information means the posted results can be described and their uncertainty considered, but the record does not support a complete audit of prespecification, missing-data handling, or multiplicity control.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety summary lists serious adverse events affecting 0 participants in each group: the 4 mg group had 11 participants at risk, the 8 mg group had 13, and placebo had 12. Deaths are listed as 0 in every group. These are the serious-event figures in the registry record; no serious-event terms are listed.

The counts for participants affected by other adverse events are 6 of 11 at risk in the 4 mg group, 7 of 13 in the 8 mg group, and 7 of 12 in the placebo group. These counts are separate from the serious-event figures. They describe participants affected, not the total number of event episodes or their severity, duration, or relationship to treatment. The registry record does not provide event-level descriptions in the posted safety summary.

These data should be read as descriptive observations from a small study. A count of 0 serious events does not establish that serious events cannot occur, and similar counts of other adverse events do not establish equivalence between groups. The record does not report sufficient detail to compare specific event types, exposure-adjusted rates, or safety laboratory findings. The listed laboratory outcomes do not have numeric results in the information reported.

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

The posted results describe a completed, randomized study of IRL201104 at 4 mg and 8 mg compared with placebo in adults with active EoE. For the primary Week 4 change in peak esophageal intraepithelial eosinophil count, the group means were -9.2, -31.6, and -7.8, respectively. Recalculated unadjusted mean differences versus placebo have broad confidence intervals that include zero. The results therefore leave substantial uncertainty about the size and direction of the group differences.

These findings do not establish whether a difference is clinically important. The registry record does not report a threshold for meaningful change, participant-level results, or an interpretation of the primary endpoint in relation to symptoms. The histologic outcome is distinct from the listed dysphagia symptom outcome, for which numeric results are not reported in the registry record. Evidence about one measure cannot be assumed to answer questions about the other.

The results also do not establish that the groups are equivalent. An imprecise estimate with an interval spanning zero may be compatible with no difference as well as differences in either direction. Conversely, a group mean difference does not alone show a causal effect or a reliable treatment benefit. The recalculated comparisons are unadjusted, and the registry record does not report the sponsor’s statistical analysis details, multiplicity strategy, or missing-data handling.

The small groups and large observed standard deviations limit precision. The secondary outcomes add some descriptive information, but not a consistent or complete basis for resolving the primary uncertainty. Safety observations are also limited by the number of participants and by the level of detail in the posted record. The trial should therefore be understood as a Phase 2a study with estimates that characterize the participants and outcomes reported, rather than as a definitive assessment of efficacy or safety.

17. Why This Trial Matters Statistically

Statistically, this study illustrates the distinction between a group average and a precise estimate of a group difference. The primary means differ numerically, but the recalculated intervals are broad and encompass zero. Without attention to uncertainty, readers might overemphasize the point estimate for the 8 mg group or infer too much from the 4 mg result. The confidence intervals instead show how much remains unresolved by the posted summaries.

The large standard deviations relative to the mean differences are also important. They indicate considerable variation in participant-level change, which limits how sharply group averages can be compared when each group is small. This is a common challenge in early clinical studies: an observed average can be informative for planning and description while still being too imprecise to support a firm conclusion.

The study also highlights why endpoint families need a clear analysis plan. Symptom, histologic, binary threshold, and safety outcomes answer different questions, and testing multiple comparisons without a reported multiplicity strategy complicates interpretation. Numeric secondary findings should not be elevated above the primary outcome merely because they appear more favorable or easier to interpret.

Finally, the record illustrates the importance of distinguishing sponsor-reported analyses from recalculated summaries. The posted group means and standard deviations permit unadjusted comparisons, but those are not a substitute for the prespecified analysis, if any. The registry record does not report enough analysis detail to assess all modeling and missing-data decisions. For biostatisticians and clinical researchers, this is a reminder that effect estimates, uncertainty, analysis provenance, and reporting completeness all matter when interpreting early trial results.

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.

The primary endpoint results represent 12 participants per group, and the standard deviations are large. This combination produces broad recalculated confidence intervals and limits precision. The posted summaries do not show individual data, distributions, or baseline group characteristics, so it is not possible to evaluate outliers, skew, or baseline balance directly.

The registry record does not report the original sample-size justification, detailed randomization procedures, analysis model, or sponsor-reported primary comparison. The displayed comparisons are unadjusted recalculations, and the record does not provide enough detail to verify whether the same assumptions were used in the intended analysis. Missing-data handling, protocol deviations, and sensitivity analyses are also not reported in the registry record.

Several secondary outcomes are listed without numeric results, including the symptom questionnaire and safety laboratory outcomes. The available secondary analyses do not have a reported multiplicity plan. The binary threshold outcome has very few participants meeting its threshold, limiting what can be learned from its group contrasts. Safety information is summarized at a high level, without event descriptions or further detail about the other adverse events.

The study is a Phase 2a trial with a total enrollment of 36, and the results should be interpreted in that context. The registry record does not report a clinically important difference for the primary endpoint, so statistical estimates cannot be translated into a judgment of clinical relevance from the posted information alone. These limitations restrict the conclusions that can be drawn from the record; they do not establish that unreported analyses or outcomes had any particular result.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis — NCT05084963.
• Registry record last updated 2025-05-21; status last verified 2025-05.
• Results first posted 2025-05-21.
• 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

NCT05084963 is a completed Phase 2a randomized, quadruple-masked, parallel-group, placebo-controlled, multicenter study sponsored by Revolo Biotherapeutics. It enrolled 36 adults with active eosinophilic esophagitis. Participants received intravenous IRL201104 4 mg, IRL201104 8 mg, or placebo on Days 0, 7, and 14.

The primary endpoint was mean change from baseline in peak esophageal intraepithelial eosinophil count at Week 4, reported for the Full Analysis Set. Group means were -9.2, -31.6, and -7.8, with standard deviations of 87.95, 68.09, and 104.0. Recalculated unadjusted comparisons with placebo were imprecise, with confidence intervals including zero.

The registry record lists several secondary outcomes, but numeric results are not reported for all of them. It does not report the trial’s original sample-size rationale, a detailed statistical analysis plan, multiplicity handling, or missing-data methods. The posted findings are best interpreted as descriptive, uncertain estimates from a small early-phase study.