Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES) (NCT05603754), a randomized phase 3 study. The primary outcome is Change From Baseline OA Pain in the Target Knee as Assessed by Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12.

2. Clinical Question

The question is about the between-group difference in average change, not simply whether either group’s score changed from baseline. A change score can move in the same direction in both groups; the comparative result asks whether the observed changes differ by treatment assignment. The scale ranges from 0, no pain, to 10, pain as bad as you can imagine. The posted outcome is measured at Week 12. Longer-term comparative results for this endpoint are not reported in the registry record.

3. Trial Design

STRIDES is recorded as a phase 3, multicenter, randomized, parallel-group, placebo-controlled study. The title describes a double-blind study; the registry’s masking classification is triple. The record does not explain how that classification relates to the title’s wording or identify which trial roles were masked. Allocation was randomized, but the sequence-generation and concealment procedures are not reported in the registry record.

The study enrolled 499 participants and is marked completed. The recorded start date is 2022-11-18, and the primary completion date is 2024-02-20. The treatment was a single healthcare professional-administered intra-articular injection on Day 1: lorecivivint 0.07 mg in 2 mL or vehicle. The target was the most painful knee. No repeat-dose treatment is described in the study summary.

The primary outcome was change from baseline in target-knee pain at Week 12. The registry also lists change in WOMAC physical function and change in patient global assessment at Week 12 as secondary outcomes. It records 4 outcome measures and 4 analyses, while the posted secondary-outcome descriptions include those two measures. The other outcome details are not reported in the registry record.

The primary outcome analysis used a Full Analysis Set of randomized participants who received an injection, with the stated duplicate-enrollment exclusions. The registry does not report the trial’s original sample-size justification, recruitment targets by arm, randomization details, or the full statistical analysis plan. Those omissions limit what can be inferred about the design choices and how closely the posted analyses followed the original plan.

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: The Full Analysis Set (FAS) includes all subjects who were randomized and received a study injection. 2 subjects from Placebo and 3 from Lorecivivint were excluded from FAS due to duplicate enrollments in current or previous Lorecivivint clinical trials. FAS describes the analysis set which is as complete and as close as possible to the intent-to-treat ideal of including all randomized subjects. Subjects' observed data were analyzed as randomized for the FAS without imputation.

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: The Full Analysis Set (FAS) includes all subjects who were randomized and received a study injection. The FAS is used to describe the analysis set which is as complete as possible and as close as possible to the intent-to-treat ideal of including all randomized subjects. Subjects will be analyzed as randomized for the FAS.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline OA Pain in the Target Knee as Assessed by Weekly Average of Daily Pain Numeric Rating Scale (NRS) at Week 12, measured over Baseline to Week 12.

The primary endpoint is change from baseline to Week 12 in osteoarthritis pain in the target knee. Pain was assessed using the weekly average of daily pain Numeric Rating Scale scores. Participants self-reported their average knee pain over the last 24 hours on an 11-point scale from 0, no pain, to 10, pain as bad as you can imagine. The endpoint therefore represents a patient-reported measure of pain intensity, summarized as a continuous score.

In general, repeated daily ratings can capture a person’s recent experience rather than relying on a single recollection at the end of a longer period. Averaging the daily ratings into a weekly score gives the study a defined measure to compare over time. A change-from-baseline endpoint expresses how scores moved relative to each participant’s starting point, while the between-group contrast addresses whether average movement differed between assigned groups.

The posted arm summaries are mean changes with standard deviations. Negative changes indicate scores moved down the scale, whose lower end is labeled no pain. The relevant treatment comparison is still the difference between groups, not the change within either group considered alone. The registry’s short description does not report a threshold for a clinically important difference or explain how such a threshold was selected.

7. Results Posted in the Registry

• Lorecivivint: mean -3.64 versus -3.54 on control; difference -0.10 (95% CI -0.56 to 0.36), standardized effect d = -0.04; z-test p = 0.667.

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.

Change From Baseline OA Function as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12

• 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:
  • Lorecivivint: mean -29.28 versus -28.65 on control; difference -0.63 (95% CI -5.13 to 3.87), standardized effect d = -0.03; z-test p = 0.784.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lorecivivint and the control. The interval gives the range of effects that remain compatible with the data.

Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12

• 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:
  • Lorecivivint: mean -33.84 versus -33.33 on control; difference -0.51 (95% CI -5.66 to 4.64), standardized effect d = -0.02; z-test p = 0.846.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lorecivivint and the control. The interval gives the range of effects that remain compatible with the data.

The two listed secondary outcomes concern physical function and patient global assessment at Week 12. Across them, the arm-level mean changes are similar in direction, and the re-calculated between-group contrasts are small relative to the reported variability. The sponsor-reported confidence intervals for both outcomes span zero. At a broad level, the secondary results do not present a contrasting pattern that would reverse the primary endpoint’s general finding of uncertainty about the between-group difference.

These outcomes add different perspectives: physical function concerns reported ability in the context of osteoarthritis, while patient global assessment captures the participant’s overall view of disease activity. They are related to the trial’s pain question but are not interchangeable with the primary pain score. The registry does not report a clinical-importance threshold for either secondary measure, so the numerical contrasts cannot be assessed against such a threshold.

Unadjusted secondary results carry less inferential weight when several outcomes are tested. In general, testing multiple hypotheses increases the chance that at least one result appears notable by chance. A prespecified testing hierarchy or multiplicity adjustment can address that issue, but the registry record does not report whether either was used. These secondary outcomes should therefore be treated as supportive descriptive evidence rather than as independent confirmation of a treatment effect. The record lists 4 outcome measures and 4 analyses, but details beyond the posted outcomes are not reported in the registry record.

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

• Change From Baseline OA Function as Assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscore (WOMAC Function) at Week 12
• Change From Baseline OA Disease Activity as Assessed by Patient Global Assessment at Week 12

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a numerical pain score summarized as a mean change. The posted arm summaries include the number of participants analyzed, the mean change, and the standard deviation. In general, a mean describes the center of a group’s scores, while a standard deviation describes how dispersed individual scores are around that mean. These summaries provide a compact account of the group data, but they do not show the distribution of individual responses or how many participants improved by a particular amount.

What does the mean difference represent?

The mean difference compares the average change in the lorecivivint group with the average change in the vehicle group. The re-calculated contrast is based on the posted summary statistics and is unadjusted. Because the endpoint is change from baseline, the contrast is a comparison of average changes, rather than a comparison of the groups’ baseline scores or a within-group test. The sign depends on the order of subtraction used for the comparison. In this case, a negative value indicates a more negative average change for lorecivivint than for vehicle.

In general, an unadjusted comparison does not account for additional covariates or model structure. The registry identifies the sponsor’s method as a mixed models analysis, but does not give the complete model specification, covariance structure, adjustment variables, or missing-data handling. It is therefore not possible to reproduce the sponsor’s analysis from the registry description alone. The unadjusted re-calculation is useful as a straightforward comparison of posted summaries, not as a replacement for the sponsor’s specified analysis.

What does the p-value tell the reader?

In general, a p-value measures how incompatible the observed data are with a specified null model, under the assumptions of the analysis. It is not the probability that the null hypothesis is true, nor is it a measure of the size or clinical importance of a difference. The registry reports p = 0.543 for the primary mixed-model analysis; the simple unadjusted re-calculation has p = 0.667. Both are reported comparisons, but they arise from different methods. The registry does not report whether the primary p-value was adjusted for interim looks or other testing; interim analyses are not reported in the registry record.

A conventional statistical test is often framed around a null difference of zero. In general, a p-value that does not cross a chosen significance threshold is not evidence that the groups are exactly equivalent. An equivalence or non-inferiority conclusion requires a prespecified margin and an analysis designed for that question. Such a margin and design are not reported in the registry record. The registered comparison is identified as a superiority analysis.

Why does dispersion matter?

In general, greater variability in participant scores makes a group mean less precisely estimated when sample size is held fixed. The reported standard deviations describe variability in the observed outcome. A confidence interval combines information about variability and sample size to express uncertainty in the estimated group contrast. The interval is not a range containing a known proportion of individual participants’ scores; it concerns uncertainty about the estimated comparison under the analysis assumptions.

Over-dispersion is a general issue when an analysis model assumes less variability than the data exhibit. In such circumstances, standard errors can be too small and intervals too narrow if the model does not account for the extra variability. The posted endpoint is continuous and the registry gives standard deviations, but it does not report a diagnostic assessment of model fit or over-dispersion. No claim about whether it occurred in this trial can be made from the registry record.

How do the two analyses relate?

The simple re-calculation uses posted arm means, standard deviations, and sample sizes to estimate an unadjusted difference and its uncertainty. The sponsor’s result is reported as a mixed models analysis of final values. In general, model-based results can differ from summary-statistic re-calculations because they may use different outcome definitions, covariate adjustments, repeated-measure information, or assumptions about incomplete data. The registry does not report which of those possibilities accounts for the numerical difference in this trial. The discrepancy flag is false, so the record does not identify a discrepancy requiring the sponsor analysis to take precedence over the re-calculation.

Neither analysis should be interpreted in isolation from its assumptions. The sponsor’s analysis is the reported trial analysis; the re-calculation is a transparent, unadjusted comparison based on the posted summaries. Agreement in their general pattern is informative, but does not verify unreported model details, missing-data assumptions, or prespecified analysis decisions. The registry record does not report sensitivity analyses that would show how the estimated contrast changes under alternative assumptions.

11. Confidence Intervals and Precision

The primary unadjusted re-calculation has a 95% confidence interval from -0.556 to 0.356 around the mean difference of -0.1. The sponsor-reported mixed-model result has a 95% confidence interval from -0.53 to 0.28 around -0.12. Both intervals include zero, indicating that the posted results are compatible with no between-group difference under the respective analysis, as well as with differences on either side of zero.

In general, a confidence interval gives a range of estimates compatible with the data and analysis procedure at the stated confidence level. It describes uncertainty about the estimated contrast, not a range that contains most individual participants’ outcomes. Its width reflects both the amount of information and the variability in the outcome, along with the analysis assumptions. A narrower interval conveys greater precision for the same estimand and confidence level.

The intervals do not identify a single treatment effect with certainty. The primary re-calculated interval reaches from a value favoring a more negative change with lorecivivint to a value favoring vehicle, and the sponsor interval has the same overall directional uncertainty. Since the registry does not state a clinically important difference threshold, the intervals cannot be classified against such a threshold. It is also not possible to say whether the estimates rule out all clinically meaningful effects.

Confidence intervals depend on the methods used to calculate them. The re-calculated interval is unadjusted and based on posted summary statistics; the sponsor interval comes from a mixed models analysis. The record does not describe the complete model or report sensitivity intervals under alternative assumptions. These limits matter when using interval width to judge how conclusively the trial distinguishes between possible effects.

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 trial’s original design calculations. For these continuous outcomes, the displayed counts are participants per arm, rather than total events. The assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect to detect is the stated fraction of the observed effect.

The 80% power column gives the illustrative number of participants per arm for an analysis to have an 80% chance of detecting the assumed effect, if the planning assumptions and effect are correct. The 90% power column makes the same calculation using a higher target probability of detecting that effect. Power is a design property under assumptions; it is not a probability that a finding is true or a measure of the observed trial’s evidential strength.

The rows use 100%, 75%, and 50% of the observed effect. Smaller assumed effects require more participants because a subtler group difference is harder to distinguish from random variation. The figures should therefore be read as conditional illustrations, not as recommended targets or as evidence about the adequacy of the trial’s actual design. The trial’s own sample-size justification and original design assumptions are not reported in the registry record.

These calculations are not observed power. They do not describe the probability that the completed study detected an effect after seeing its results. The planning display uses the observed effect only as an input for illustrating what sample sizes would follow under the stated assumptions.

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 = -0.100; pooled standard deviation σ = 2.445.
2. n = 2 × (1.96 + 0.842)² × 2.445² / -0.100² = 9,385.2, rounded up to 9,386 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 <- -0.1                      # observed difference in means
sigma <- 2.44514147201789                     # 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(5603754)
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 = 9,386 (80% power), 12,565 (90% power)
 75% of observed effect: n per arm = 16,685 (80% power), 22,337 (90% power)
 50% of observed effect: n per arm = 37,541 (80% power), 50,257 (90% power)
power.t.test: 9386.2 
Simulated power at n = 9,386 per arm: 0.800 (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. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary analysis as a mixed models analysis, with a mean difference of -0.12, a 95% confidence interval from -0.53 to 0.28, and p = 0.543. The unadjusted re-calculation from posted arm summaries is -0.1, with a 95% confidence interval from -0.556 to 0.356 and p = 0.667. The point estimates are close, and both intervals span zero. The sponsor result and the re-calculation therefore convey a similar broad pattern of uncertainty, although their exact estimates and p-values differ.

The re-calculation is not a reconstruction of the mixed model. It compares arm-level summaries without the model details that may have informed the sponsor analysis. The registry does not report the model specification, adjustment variables, repeated-measures structure, or handling of incomplete observations, so the reason for the difference cannot be determined. The record does not flag a discrepancy between the results. The sponsor’s analysis is the trial’s reported analysis, while the re-calculation is a supplementary, unadjusted check based on the posted summaries.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and secondary outcomes, but the posted record does not describe the complete strategy for controlling multiplicity. It is not reported whether the study used a hierarchical testing sequence, adjusted secondary p-values, or otherwise controlled the chance of false-positive findings across outcomes. Without that information, the secondary p-values should not be read as if they were necessarily the only tests conducted or as if they had a stated family-wise error guarantee. The record also does not report whether interim analyses were planned or conducted.

The primary analysis population is described as the Full Analysis Set, consisting of randomized participants who received an injection. The registry says that 2 participants from Placebo and 3 from Lorecivivint were excluded from this set because of duplicate enrollments in current or previous lorecivivint clinical trials. Other details of analysis-population definitions are not reported in the registry record. In particular, the record does not fully explain which participants contributed to every analysis or how departures from the planned population were handled.

Missing outcome data can affect a change-from-baseline analysis if the likelihood of missingness is related to outcomes or differs between groups. In general, mixed models can use available repeated observations under specified assumptions, but the assumptions and implementation matter. The registry does not report the amount or pattern of missing Week 12 data, reasons for missingness, imputation procedures, or sensitivity analyses. It is therefore not possible to assess from the registry record whether missing-data assumptions materially affect the result.

The protocol, full statistical analysis plan, and original sample-size justification are not reported in the registry record. Their absence limits evaluation of whether outcomes, populations, model choices, and multiplicity procedures were prespecified in the manner used for the posted results.

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 2% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: non-cardiac chest pain (0.4%), cholecystitis acute (0.4%), angina pectoris (0.4%), hip fracture (0.4%), chronic obstructive pulmonary disease (0.4%).

The registry reports serious adverse events among 2 of 242 participants at risk in the lorecivivint group and 3 of 249 at risk in the vehicle group. It reports other adverse events among 37 of 242 participants at risk in the lorecivivint group and 26 of 249 at risk in the vehicle group. No deaths are reported in either group. These are descriptive counts as posted; they are not adjusted comparisons.

The record lists several serious adverse event terms, each reported as 0.4%: non-cardiac chest pain, acute cholecystitis, angina pectoris, hip fracture, and chronic obstructive pulmonary disease. A listed event does not by itself establish that the event was caused by the assigned injection. The registry information does not provide enough detail to assess event timing, duration, severity beyond the serious classification, or relatedness to treatment for each participant.

Safety counts should be interpreted in the context of the populations at risk and the follow-up information available. The registry does not report a detailed safety analysis plan or exposure-adjusted rates. The posted figures alone do not establish a causal safety difference between groups.

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

The primary result is an estimate of the difference between groups in average change in target-knee pain at Week 12. Both the sponsor-reported analysis and the unadjusted re-calculation have confidence intervals that include zero. The data therefore do not provide a precise estimate of the direction and size of the comparative difference. The posted results are not proof that the groups are exactly the same, because the intervals also include values on either side of zero.

Nor does a mean change summarize every participant’s experience. Group means can conceal variation in individual outcomes, and the registry does not report the distribution of responses or the proportion of participants who reached a particular improvement threshold. A clinically meaningful threshold is not reported, so the results cannot be interpreted against one. The study’s endpoint is a patient-reported pain scale, which is relevant to the trial question, but it is only one measure of the condition.

The secondary outcomes offer related information about function and patient global assessment, with a broad pattern similar to the primary comparison. Their interpretation is limited by the unreported multiplicity strategy and the absence of clinical-importance thresholds. Safety counts are also descriptive, and they do not establish that an event was caused by treatment.

Overall, the registry record supports a careful description of the posted estimates and their uncertainty. It does not support a claim that the treatment is effective or ineffective, that the groups are equivalent, or that the observed event counts prove a causal safety profile. Interpretation is further constrained by unreported details about missing data, model specifications, and the original analysis plan.

18. Why This Trial Matters Statistically

This trial illustrates why a between-group estimate and its confidence interval are more informative than focusing only on whether a p-value crosses a threshold. The two primary analyses report small, nearby point estimates, while both confidence intervals span zero. Reading the estimate alongside its uncertainty makes clear that the data do not pinpoint a single comparative effect or direction.

It also shows the value of distinguishing a sponsor-reported model analysis from a simple unadjusted re-calculation. The two are not interchangeable: the sponsor analysis is identified as a mixed models analysis, whereas the re-calculation uses the arm-level summaries. Their broadly similar pattern is useful context, but the record does not include enough model detail to reproduce the sponsor analysis or attribute the small numerical differences to particular modeling choices.

The sample-size illustrations offer a separate statistical lesson. Planning needs depend on the effect size a study aims to detect, and smaller assumed effects require larger participant counts under the stated assumptions. Those illustrations are not a measure of the completed trial’s observed power and do not reveal the trial’s original design rationale.

Finally, the record demonstrates how missing analysis-plan details affect interpretation. The primary outcome and two secondary outcomes are identifiable, but multiplicity procedures, missing-data handling, and the original sample-size justification are not reported. Statistical interpretation is strongest when estimates are considered together with uncertainty, design, analysis populations, and transparent reporting of the assumptions.

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.

Several trial-specific limitations follow from information not reported in the registry record. The full statistical analysis plan is unavailable in the record, including model specification, covariate adjustment, missing-data handling, and the approach to multiplicity. These omissions make it difficult to assess the extent to which the posted analyses reflect prespecified decisions and to reproduce the sponsor’s mixed-model results.

The primary analysis population is defined as randomized participants who received an injection, with specified exclusions for duplicate enrollments. The registry does not report a detailed participant flow or a complete accounting of participants contributing to each outcome analysis. Week 12 missingness, reasons for missing data, and sensitivity analyses are also not reported. These details would help readers evaluate whether the analyzed participants represent the randomized groups and how incomplete outcome data may affect the estimates.

The primary comparison is available at Week 12, but longer-term results for this endpoint are not reported in the record. The registry does not report a clinically important difference threshold for the pain measure or the secondary outcomes. This prevents judging whether the confidence intervals exclude effects that might matter to participants.

The record describes a multicenter randomized trial but does not report the randomization implementation, site-level results, participant characteristics, or detailed masking roles. It also does not provide enough safety detail to determine event relatedness or timing. These limitations do not negate the posted estimates, but they constrain conclusions about generalizability, analysis robustness, and causal interpretation.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Knee Osteoarthritis (STRIDES) — NCT05603754.
• Registry record last updated 2026-09-01; status last verified 2026-08.
• Results first posted 2026-09-01.
• 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

STRIDES (NCT05603754) is a completed phase 3, multicenter, randomized, parallel-group, placebo-controlled trial of a single intra-articular lorecivivint injection versus vehicle for moderate to severe symptomatic knee osteoarthritis. The record reports enrollment of 499 and a primary endpoint of change from baseline in target-knee pain at Week 12, measured with the weekly average of daily pain Numeric Rating Scale scores.

The sponsor-reported mixed-model primary comparison has a mean difference of -0.12, a 95% confidence interval from -0.53 to 0.28, and p = 0.543. The unadjusted re-calculation gives -0.1, with a 95% confidence interval from -0.556 to 0.356 and p = 0.667. Both intervals include zero. The record also posts two secondary outcomes and descriptive adverse event counts. Multiplicity procedures, missing-data handling, the complete model specification, and the original sample-size justification are not reported in the registry record.