A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (NCT05611671), a randomized phase 2 study. The primary outcome is Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS).

2. Clinical Question

The clinical question is about the proportion of participants meeting a specified remission definition at a fixed time, rather than change in a continuous score or time until an event. The same trial also assessed clinical response using the modified Mayo Clinic Score. These outcomes summarize different thresholds of disease activity; response is not interchangeable with remission.

The study title identifies it as a Phase 2b evaluation of safety and efficacy. The registry record lists 280 participants enrolled, and the primary endpoint analysis includes treatment-group denominators of 69, 71, 70, and 70. These group-specific denominators are the ones used in the posted primary outcome results. The registry describes all randomized participants as the endpoint population, but further details about missing endpoint measurements and how they were handled are not reported in the registry record.

3. Trial Design

This was a randomized, parallel-group, placebo-controlled Phase 2b study of MORF-057 in adults with moderately to severely active ulcerative colitis. It compared three active oral regimens with matching placebo. Participants received their assigned regimen for 12 weeks. The registry record describes the study as double-blind and its masking as triple; it does not report which parties were included in that masking description.

The active groups received MORF-057 200 mg twice daily, 100 mg twice daily, or 100 mg once daily in the morning. The control group received matching placebo. The primary endpoint was assessed at Week 12. The posted results list 69 participants for the 200 mg twice-daily group, 71 for the 100 mg twice-daily group, 70 for the once-daily morning group, and 70 for placebo. The record lists overall enrollment as 280.

The registry classifies the study as completed. The start date is 2022-11-21 and the primary completion date is 2024-11-28. The sponsor is Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company). The registry lists inflammatory bowel diseases and ulcerative colitis as conditions.

These design features establish the basic comparison: randomized groups receiving active regimens or placebo were followed through the stated treatment period, with remission assessed at a common time point. The original sample-size justification, allocation ratio, concealment procedures, planned statistical model, and detailed analysis plan are not reported in the registry record. The registry also does not report whether any interim analyses were planned or conducted. Those omissions limit how fully the design and inferential procedures can be reconstructed from the posted record.

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: All randomized participants.

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: All randomized participants.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS), measured over Week 12.

The primary endpoint is the percentage of participants in clinical remission at Week 12, determined using the modified Mayo Clinic Score (mMCS). The mMCS combines an endoscopic subscore, a stool frequency subscore, and a rectal bleeding subscore. Each component is scored from 0 to 3, and the total score ranges from 0 to 9, with higher scores indicating more severe disease.

Clinical remission is defined by meeting all of the stated component thresholds: a rectal bleeding subscore of 0, a stool frequency subscore of 1 or less, and an endoscopy subscore of 1 or less without friability. This definition combines symptoms with an endoscopic assessment. It creates a binary outcome for each participant: the remission criteria are either met or not met. The group-level result is then expressed as a percentage.

A composite endpoint can capture several aspects of disease activity in a single outcome, but its interpretation depends on the component definitions and thresholds. A participant must satisfy all specified remission criteria; a favorable value on one component alone does not establish remission. The percentage therefore describes how many participants crossed the defined threshold, rather than the average degree of improvement in each component.

The registry record identifies all randomized participants as the primary endpoint population. It does not report additional details about the handling of missing component assessments or the statistical analysis population beyond that description.

7. Results Posted in the Registry

• MORF-057 200 mg BID: 31.9% (22/69) versus 24.3% (17/70) on control; risk difference 7.6 percentage points (95% CI -7.3 to 22.5), risk ratio 1.31 (0.77–2.25); unadjusted two-proportion z-test p = 0.319.
• MORF-057 100 mg BID: 23.9% (17/71) versus 24.3% (17/70) on control; risk difference -0.3 percentage points (95% CI -14.5 to 13.8), risk ratio 0.99 (0.55–1.77); unadjusted two-proportion z-test p = 0.962.
• MORF-057 100 mg QD-M: 17.1% (12/70) versus 24.3% (17/70) on control; risk difference -7.1 percentage points (95% CI -20.5 to 6.2), risk ratio 0.71 (0.36–1.37); unadjusted two-proportion z-test p = 0.297.

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 in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS)

• 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:
  • MORF-057 200 mg BID: 62.3% (43/69) versus 54.3% (38/70) on control; risk difference 8.0 percentage points (95% CI -8.3 to 24.4), risk ratio 1.15 (0.87–1.52); unadjusted two-proportion z-test p = 0.337.
  • MORF-057 100 mg BID: 53.5% (38/71) versus 54.3% (38/70) on control; risk difference -0.8 percentage points (95% CI -17.2 to 15.7), risk ratio 0.99 (0.73–1.34); unadjusted two-proportion z-test p = 0.927.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between MORF-057 200 mg BID 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 MORF-057 100 mg BID and the control. The interval gives the range of effects that remain compatible with the data.

The registry posts one secondary outcome: clinical response at Week 12 using the modified Mayo Clinic Score. Across the four groups, response percentages range from the low fifties to the low sixties. The response pattern is not identical to the remission pattern, which is expected because response and remission are different endpoint thresholds. Response is not evidence that the remission endpoint was met.

The secondary outcome comparisons also have uncertainty. The sponsor-reported intervals for the posted active-versus-placebo response comparisons include zero. The registry does not post a sponsor comparison for the 100 mg once-daily morning group for this secondary outcome. As with the primary endpoint, group percentages and point estimates describe the observed sample; they do not alone establish a difference between treatment groups.

Secondary outcomes can add context by showing whether the general pattern of results is similar across related measures. Here, the response results do not provide a clear, independent resolution of the uncertainty in the primary remission comparisons. The two endpoints are related through the mMCS but represent distinct outcome definitions, so a response result cannot substitute for the primary remission result.

Unadjusted secondary comparisons carry less weight for confirmatory conclusions because examining multiple outcomes and treatment comparisons increases the chance of apparently notable findings arising by chance. The registry record does not report a multiplicity adjustment or a hierarchy specifying how the outcomes were to be tested. The secondary results are therefore best treated as supportive and descriptive rather than as stand-alone confirmation.

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

• Percentage of Participants in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS)

9. Statistical Interpretation

10. Statistical Methods Explained

For a binary endpoint such as clinical remission, each participant either meets the endpoint definition or does not. A group percentage expresses the proportion meeting that definition. The primary results report percentages by randomized treatment group, while the comparisons express differences between each active regimen and placebo. A risk difference is an absolute contrast between two proportions. It is expressed in percentage points when the proportions are presented as percentages; a positive value means the active-group proportion is higher, and a negative value means it is lower.

What does a confidence interval describe?

A confidence interval gives a range of estimates compatible with the observed data under the statistical method used. It is not a range of individual participant outcomes, and it does not guarantee that the true effect lies within the interval. An interval that includes zero is compatible with no group difference, while also allowing effects in either direction. Its width conveys precision: a wider interval leaves more uncertainty about the effect size than a narrower one. The sponsor-reported 95% intervals for all three primary comparisons include zero.

How should p-values be read?

A p-value describes how unusual data at least as incompatible with a specified null hypothesis would be, if that null hypothesis and the analysis assumptions were true. It is not the probability that the null hypothesis is true and is not a measure of clinical importance. The posted p-values are unadjusted recalculations. They should be considered alongside effect estimates and confidence intervals, not used alone to label a comparison as positive or negative.

What is the difference between sponsor analyses and recalculations?

The registry includes sponsor-reported risk differences with 95% confidence intervals. Separately, the posted unadjusted recalculations are simple comparisons derived from the group-level counts and denominators. Such recalculations can help readers understand the scale of the observed contrast, but they may not reproduce the sponsor's analysis method, covariate adjustment, missing-data approach, or other prespecified choices. The sponsor's own analysis takes precedence when interpreting the trial's reported analysis. In this record the discrepancy flag is false, but that does not establish that the two approaches used identical methods.

Why can the estimates remain uncertain?

Binary outcomes contain less information about gradations in outcome than a continuous measure: a participant just short of the remission threshold is counted the same way as one further from it. The number of participants in each group also affects precision. With group sizes of 69 to 71 for the primary endpoint, estimates can remain uncertain, particularly when the proportion meeting the endpoint is not close to either extreme. Random variation in which participants meet the threshold can shift percentages and differences from one study sample to another.

What does over-dispersion mean in general?

General statistical explanation: over-dispersion occurs when observed variability is greater than a model assumes. If present and ignored, it can make standard errors too small and intervals too narrow. The registry record does not report whether over-dispersion was assessed or relevant to the primary analysis, and no claim about it can be drawn from the posted endpoint summaries alone.

The record does not report the sponsor's statistical model, covariates, confidence-interval construction, or missing-data method. It also does not report whether the primary comparisons were intended to be adjusted for multiplicity. The simple recalculations should therefore be understood as unadjusted summaries rather than a substitute for a fully specified trial analysis.

11. Confidence Intervals and Precision

The primary endpoint comparisons are imprecise. The sponsor-reported 95% confidence interval for MORF-057 200 mg twice daily versus placebo ranges from -7.76 to 21.18 percentage points. For 100 mg twice daily versus placebo, it ranges from -13.99 to 13.17 percentage points. For 100 mg once daily in the morning versus placebo, it ranges from -19.74 to 5.88 percentage points. Each interval includes zero, and each allows values on both sides of zero.

These intervals make clear why the observed percentages alone are not enough to decide whether the underlying group differences are large, small, or absent. For example, the highest observed remission percentage is in the 200 mg twice-daily group, but its interval remains compatible with a negative difference as well as a positive one. The other comparisons also leave considerable uncertainty about the direction and size of the difference.

A confidence interval is not a statement that all values within it are equally plausible, nor does it account for every uncertainty in trial conduct or analysis. It is conditional on the method and assumptions used to construct it. The registry record does not report the interval method, so the sponsor-reported intervals are best interpreted as posted without assuming a particular model.

Precision is distinct from whether an estimate is clinically important. A narrow interval can still contain effects that matter or do not matter, depending on the clinical context; a wide interval can leave both possibilities open. The registry record does not identify a threshold for a clinically important difference. Accordingly, these intervals describe statistical uncertainty but do not determine clinical importance.

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 are participants per arm for these binary-outcome comparisons. They are not total events. The planning illustration assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It uses the observed effect as a starting point and considers planning for 100%, 75%, or 50% of that observed effect. The original trial's sample-size justification and design assumptions are not reported in the registry record.

The 80% power column describes the number of participants per arm that the stated planning calculation estimates would be needed for an 80% chance of detecting the selected effect under its assumptions. The 90% power column gives the corresponding planning estimate for a 90% chance. These are design calculations, not guarantees: actual power depends on the true effect and whether the calculation's assumptions hold.

Smaller target effects require more participants because they are harder to distinguish from random variation. Thus, planning for 75% or 50% of the observed effect leads to larger participant requirements than planning for the full observed effect. When the observed effect is close to zero, planning around a fraction of it can produce extremely large figures; those values reflect the arithmetic of the illustration, not a practical recommendation or a claim about what the study should have enrolled.

These figures are not observed power. They do not measure the probability that the completed trial found an effect, and they should not be used to reinterpret the observed results as either successful or unsuccessful. They are forward-looking illustrations based on the specified assumptions, distinct from the trial's actual enrollment of 280 participants.

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 = 0.243; treatment proportion p₁ = 0.319; average p̄ = 0.281.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6356 = 1.2457.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6333 = 0.5330.
4. n = (1.2457 + 0.5330)² / (0.0760)² = 548.0, rounded up to 548 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 <- 0.242857142857143                          # control proportion
p1 <- 0.318840579710145                          # 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(5611671)
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 = 548 (80% power), 734 (90% power)
 75% of observed effect: n per arm = 955 (80% power), 1,278 (90% power)
 50% of observed effect: n per arm = 2,101 (80% power), 2,813 (90% power)
power.prop.test: 548 
Simulated power at n = 548 per arm: 0.804 (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

The registry reports sponsor analyses as risk differences with 95% confidence intervals for each active regimen versus placebo. For the primary endpoint, these are 6.71 percentage points for 200 mg twice daily, -0.41 percentage points for 100 mg twice daily, and -6.93 percentage points for 100 mg once daily in the morning. Their corresponding intervals are -7.76 to 21.18, -13.99 to 13.17, and -19.74 to 5.88.

The posted recalculations are unadjusted comparisons based on the event counts and group denominators. They are included as a transparent, simple check of the group-level summaries, not as a replacement for the sponsor's analysis. The sponsor's own analysis takes precedence for interpreting the trial's reported inferential results. The discrepancy flag is false, so the record does not identify a discrepancy between the reported results and the recalculation.

The registry does not identify the sponsor's method for estimating the risk differences or constructing the intervals. It also does not report whether covariates, missing-data procedures, or other adjustments were used. Similar-looking estimates would not, by themselves, establish that the methods were identical. The p-values attached to the recalculations are unadjusted and should not be attributed to the sponsor's reported analyses, which do not include p-values in the posted results.

15. Multiplicity, Missing Data and Analysis Populations

The trial compares three MORF-057 regimens with placebo for the primary endpoint and also reports a secondary endpoint. Considering multiple comparisons raises a multiplicity issue: the more hypotheses examined, the greater the chance that at least one result appears unusually favorable by chance, if all comparisons are interpreted without adjustment. Statistical procedures can address this in different ways, but the registry record does not report a multiplicity strategy, testing hierarchy, or family-wise error plan.

The posted recalculated p-values are unadjusted. They should not be interpreted as if they had already accounted for the three active-versus-placebo comparisons, the secondary outcome, or any other analyses. The sponsor-reported primary risk differences are accompanied by confidence intervals, but the record does not state whether those intervals were adjusted for multiple comparisons. The secondary outcome record also does not describe an adjustment procedure.

The primary endpoint population is listed as all randomized participants. However, the record does not report how missing Week 12 data were handled, whether any participants lacked an endpoint assessment, or whether imputation or other assumptions were used. The posted group denominators do not resolve those questions. The registry record also does not provide a detailed analysis-population definition beyond the all-randomized description for the primary endpoint.

These omissions matter because missing-data decisions and multiplicity procedures can affect the interpretation of uncertainty and the strength of confirmatory claims. They do not change the arithmetic of the observed group percentages, but they limit the ability to assess whether the reported inferential results follow a prespecified strategy. The original statistical analysis plan, interim-analysis arrangements, and handling of deviations from assigned treatment are not reported in the registry record.

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: intervertebral disc protrusion (1.4%), colitis ulcerative (1.4%), aspartate aminotransferase increased (1.4%), pneumothorax (1.4%).

The posted serious adverse event counts are 1 among 70 participants at risk in the MORF-057 200 mg twice-daily group, 3 among 71 in the 100 mg twice-daily group, 0 among 70 in the 100 mg once-daily morning group, and 1 among 69 in the placebo group. No deaths are listed in any group. These are counts during the recorded study period; the record does not provide further detail about exposure-adjusted rates or time at risk.

The registry also reports other adverse event counts of 9, 8, 5, and 10, respectively, for those groups. These should not be confused with serious adverse events. The listed serious-event terms include intervertebral disc protrusion, ulcerative colitis, increased aspartate aminotransferase, and pneumothorax, each reported as 1.4%.

Small counts are difficult to compare reliably, and differences in counts alone do not establish a causal relationship to treatment. The registry record does not provide enough detail to assess event timing, duration, severity beyond the serious classification, or attribution. These safety counts describe what was posted; they are not a complete assessment of comparative safety.

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

The posted primary results describe the proportion of randomized participants meeting the mMCS remission definition at Week 12 in each treatment group. The sponsor-reported risk-difference intervals include zero for all three active-versus-placebo comparisons, and the unadjusted recalculated p-values do not provide a clear separation from placebo. At the same time, the intervals allow a range of possible differences, so the results do not establish equivalence or rule out effects in either direction.

The observed remission percentages vary across the regimens, with the highest percentage in the 200 mg twice-daily group. That descriptive pattern is not sufficient to establish a dose-response relationship or a treatment effect. The results come from a Phase 2b study with group sizes in the range of 69 to 71 for the primary endpoint, and the estimates remain uncertain.

The endpoint is a composite threshold based on rectal bleeding, stool frequency, and endoscopic assessment. It is not a direct measure of every aspect of ulcerative colitis or of outcomes beyond Week 12. The registry record does not report a threshold for clinical importance, longer-term results, or a complete account of missing-data handling and analysis methods. Consequently, statistical estimates alone cannot answer every clinical question about the regimens.

The secondary clinical response outcome provides related but distinct information, and does not resolve the uncertainty in the remission comparisons. The safety counts are also limited in what they can establish, particularly when event numbers are small and details of attribution and exposure are not posted. These findings describe the registry results and their precision; they should not be taken as medical advice or as a definitive judgment about treatment.

18. Why This Trial Matters Statistically

This study illustrates why interpreting a clinical trial requires more than comparing percentages. The remission proportions are easy to read, but their uncertainty is better understood alongside the risk differences and confidence intervals. In this trial, the reported intervals span zero and extend in both directions, making the uncertainty about the treatment contrasts visible.

It also shows how endpoint definitions shape conclusions. The primary outcome is a binary remission threshold constructed from symptom and endoscopic components. A participant's classification depends on satisfying the specified criteria, while a separate clinical response endpoint captures a different threshold. Related outcomes can tell different stories without being contradictory.

The comparison structure raises the importance of multiplicity. Three active regimens and a secondary outcome create several opportunities for comparisons, yet the registry record does not report a multiplicity plan. Without that information, unadjusted results should be interpreted cautiously, especially when drawing confirmatory conclusions from any one comparison.

Finally, sponsor-reported analyses and transparent unadjusted recalculations serve different purposes. The latter can help readers inspect the scale of observed differences, while the sponsor analysis remains the primary reported inferential analysis. The registry's missing details about analysis methods and missing data underscore the value of complete statistical reporting for judging precision and reproducibility.

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.

Several trial-specific limitations of interpretation arise from what the registry record does not report. It does not give the original sample-size justification, the statistical analysis plan, the method used for the sponsor-reported confidence intervals, or whether the primary comparisons were adjusted for multiplicity. Without these details, the inferential procedures cannot be fully reconstructed.

The record describes the primary endpoint population as all randomized participants but does not explain how missing Week 12 assessments were handled or give a detailed account of the analysis population. This leaves uncertainty about whether the posted percentages use an approach that accounts for missing data, and whether all randomized participants contributed endpoint information.

The primary comparison estimates are imprecise, with sponsor-reported 95% confidence intervals that include zero. Group sizes for the primary endpoint are 69 to 71 participants. These features limit the precision with which the data identify the size and direction of the treatment contrasts. The registry does not report a clinically important difference threshold, so the clinical relevance of particular values within the intervals cannot be determined from these results alone.

The results concern a Week 12 endpoint and do not, on their own, describe longer-term outcomes. The record does not provide details about adherence, exposure-adjusted safety, or event attribution. The safety counts are small, and the posted counts cannot establish whether an event was caused by treatment. These are limits on what can be concluded from the registry record, not evidence that unreported procedures or outcomes were absent.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC — NCT05611671.
• Registry record last updated 2026-10-15; status last verified 2026-09.
• Results first posted 2025-12-15.
• 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.

23. Record Summary

NCT05611671 is a completed Phase 2b randomized, parallel-group, placebo-controlled study of MORF-057 in adults with moderately to severely active ulcerative colitis. The study evaluated three oral regimens for 12 weeks: 200 mg twice daily, 100 mg twice daily, and 100 mg once daily in the morning, compared with matching placebo. The registry lists 280 participants enrolled.

The primary endpoint was clinical remission at Week 12 using the modified Mayo Clinic Score. Sponsor-reported risk-difference confidence intervals for each active regimen versus placebo include zero. The registry also posts clinical response as a secondary outcome and serious adverse event counts by group. Important details about the original sample-size justification, statistical analysis plan, multiplicity, and handling of missing endpoint data are not reported in the registry record.