This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Janus Kinase Inhibition in Granuloma Annulare (NCT05650736), a na phase 2 study. The primary outcome is Percentage BSA Involvement by Active GA.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05650736 |
| Phase | Phase 2 |
| Condition | Granuloma Annulare |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | William Damsky |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 10 patients with moderate to severe granuloma annulare (GA) affecting at least 5% body surface area (BSA). The condition named in the registry record is granuloma annulare.
Intervention
Participants received abrocitinib 200 mg daily for 6 months. The stated primary objective was to assess JAK1-specific inhibition in treating GA.
Comparator
The study is listed as single-group, with allocation recorded as NA and no masking. A separate comparator group is not described in the registry record.
Primary question
The primary question was how percentage BSA involvement by active GA changed after 6 months of treatment. The registry record describes measurement at baseline and 6 months, but numerical outcome results are not reported in the registry record.
This design addresses change over time within the treated group. It does not, by itself, compare the observed change with what would have happened over the same period without treatment or with another intervention. The study therefore describes a clinical question about change during treatment, rather than a randomized estimate of the difference between treatments. The record does not report a numerical estimate of that change, so the magnitude and direction of the primary outcome cannot be assessed from the registry record.
3. Trial Design
This is a phase 2, completed, single-group study listed under NCT05650736, titled “Janus Kinase Inhibition in Granuloma Annulare.” The official title is “JAK1 Inhibition in Granuloma Annulare: an Opportunity for Pathogenesis Directed Therapy.” The record lists enrollment of 10 and identifies abrocitinib 200 mg daily as the intervention. The described treatment period was 6 months.
The listed study start date is 2023-10-27, and the primary completion date is 2024-05-07. The current status in the record is COMPLETED. The population description specifies moderate to severe GA affecting at least 5% BSA. The registry record does not report further eligibility criteria or a more detailed account of recruitment.
Allocation is recorded as NA, masking as NONE, and the model as SINGLE GROUP. These entries describe a study without a randomized allocation or a masked comparison, and no separate control arm is listed. Consequently, its main design feature is measurement in one treated group, not a like-for-like comparison between treatment groups. A change from baseline may be described for the participants measured, but a single-group design cannot isolate treatment effects from other possible explanations for change over time.
The primary outcome is percentage BSA involvement by active GA, with measurements specified at baseline and 6 months. The record also lists four secondary outcomes: mean GASMI score, mean Skindex-16 score, mean concentration of CD3e mRNA in skin before and after treatment, and mean concentration of IFN-gamma protein before and after treatment. Further protocol details, including a statistical analysis plan and sample-size justification, are not reported in the registry 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
| Stage | Abrocitinib 200 mg Daily |
|---|---|
| STARTED | 10 |
| Compliant with intended dose (Abrocitinib 200 mg once daily) | 6 |
| Not Compliant with intended dose (Abrocitinib 200 mg once daily) | 2 |
| COMPLETED | 6 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Abrocitinib 200 mg Daily |
|---|---|
| Withdrawal by Subject | 2 |
| Protocol Violation | 2 |
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.
| Characteristic | Unit | Abrocitinib 200 mg Daily |
|---|---|---|
| Participants analysed | 10 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 10 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 10 |
| Comorbidities: None | Participants | 3 |
| Comorbidities: Hypertension | Participants | 3 |
| Comorbidities: Hyperlipidemia | Participants | 1 |
| Comorbidities: Anxiety | Participants | 1 |
| Comorbidities: Obesity | Participants | 1 |
| Comorbidities: Polycystic ovary syndrome (PCOS) | Participants | 1 |
| Comorbidities: Hypothyroidism | Participants | 3 |
| Comorbidities: Osteoarthritis | Participants | 1 |
| Comorbidities: Seasonal allergies | Participants | 1 |
| Comorbidities: Pre-diabetes | Participants | 1 |
| Prior treatments: Topical corticosteroids | Participants | 9 |
| Prior treatments: Isotretinoin | Participants | 2 |
| Prior treatments: Oral corticosteroids | Participants | 1 |
| Prior treatments: Intralesional corticosteroids | Participants | 4 |
| Prior treatments: Dapsone | Participants | 1 |
| Prior treatments: Methotrexate | Participants | 3 |
| Prior treatments: Adalimumab | Participants | 1 |
| Prior treatments: Topical tofacitinib | Participants | 4 |
| Prior treatments: Topical tacrolimus | Participants | 2 |
| Prior treatments: ROM antibiotics (rifampicin, ofloxacin, minocycline combination) | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage BSA Involvement by Active GA, measured over Baseline and 6 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percent BSA |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is percentage BSA involvement by active GA, measured at baseline and 6 months. BSA refers to the body surface area affected by GA; expressing involvement as a percentage gives a measure of the extent of affected skin. The primary objective describes evaluating percentage change after 6 months of abrocitinib 200 mg daily in participants with moderate to severe disease.
In general, a repeated measure of affected body surface area can describe whether the extent of involvement changed over the treatment period. A baseline measurement gives a reference for interpreting the later measurement. The choice of a continuous measure also allows the result to be reported as a group mean, with a measure of spread such as the standard deviation. The registry record identifies the primary measure as a mean with standard deviation, but does not report numerical baseline or 6-month values or a numerical change estimate.
The endpoint captures one aspect of GA: the extent of BSA involvement. It should not be treated as a complete description of severity, morphology, quality of life, or skin biomarkers. The record lists separate secondary outcomes for those other dimensions. Because numerical endpoint results are not reported in the registry record, the observed change and its precision cannot be interpreted from the available results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies a primary outcome and a measurement timeframe, but numerical results for the primary endpoint are not reported in the registry record. In particular, it does not report baseline and 6-month means, a percentage-change estimate, a standard deviation for observed values, a confidence interval, or a p-value. Without these results, the direction, size, and precision of any change in BSA involvement cannot be described.
The study enrolled 10 participants in one treated group. This matters for interpretation because there is no separate control group against which to compare the change over time. Even if a within-group change estimate were reported, it would describe what occurred among participants measured during treatment; it would not, on its own, quantify a treatment-versus-control difference. The registry record also lists no masking. These design features limit the kinds of conclusions that can be drawn from any within-group observation.
The record lists five outcome measures and five analyses, including the primary endpoint and secondary measures of GA severity and morphology, skin-related quality of life, and skin biomarkers. Numerical findings for these outcomes are not reported in the registry record. Therefore, the listed outcomes show what was intended to be assessed, not what was observed. The record does not support a conclusion about the magnitude or consistency of changes across these different measures.
Safety results are reported as counts for the abrocitinib group: 0 participants with a serious adverse event, 9 with other adverse events, and 0 deaths. These counts are descriptive. The registry record does not list serious adverse-event terms, and the count of participants with other adverse events does not describe the types, severity, timing, or duration of those events. These figures should not be read as a complete account of risk.
Overall, the registry entry documents a small, completed, single-group study and identifies its intended outcomes. It does not provide the numerical efficacy results needed to assess observed change or its uncertainty. The design also lacks a concurrent comparator, so it cannot establish how outcomes would have differed under another treatment or no treatment.
9. Statistical Methods Explained
What does the mean describe?
The primary measure is continuous: percentage BSA involvement by active GA. The registry record specifies a mean as the summary parameter and standard deviation as the dispersion measure. In general, a mean describes the central value of a set of measurements, while a standard deviation describes how much individual measurements vary around that mean. These summaries answer different questions: the mean describes the group average, and the standard deviation describes variation among measurements. Neither numerical summary is reported for the primary outcome in the registry record.
What does a change over time mean in a single-group study?
The primary outcome is described at baseline and 6 months. In general, a within-group change compares measurements from the same study group across time. It can describe the observed course during the study period, but it is not a randomized comparison. Without a concurrent comparator, changes cannot be separated from other influences that may also affect measurements over time. This is a design limitation, not a calculation problem, and it remains relevant even if a change estimate is precise.
The record describes the primary objective in terms of percentage change in BSA involvement after treatment. A percentage-change summary expresses change relative to a reference measurement. The registry record does not report the numerical values needed to describe the observed result, and no new calculation can be made from the listed design information alone.
How should precision be understood?
General explanation: a confidence interval describes a range of values compatible with the data and a statistical procedure, and its width conveys information about precision. A point estimate alone does not show how uncertain the estimate is. The registry record does not report a confidence interval or a numerical primary outcome estimate, so neither the estimated change nor its precision can be assessed from the reported information.
The number enrolled was 10. In general, estimates from a small group can be sensitive to the measurements of individual participants. That observation does not establish how variable the outcome was in this study; the outcome variability is not reported in the registry record. It is also not a substitute for an interval estimate, which is not reported.
What do the secondary outcomes add?
The record lists mean GASMI score, mean Skindex-16 score, mean concentration of CD3e mRNA in skin before and after treatment, and mean concentration of IFN-gamma protein before and after treatment. These outcomes concern different aspects of disease severity, quality of life, and biological measurement. In general, multiple outcomes can provide a broader account of what a study measured, but each needs its own clearly reported result and interpretation. Numerical results for the listed secondary outcomes are not reported in the registry record.
General explanation: when multiple outcomes or statistical tests are considered, the chance of at least one apparently notable result can increase if no adjustment or interpretation plan accounts for that multiplicity. The registry record does not report a multiplicity procedure or explain how the listed outcomes were prioritized beyond identifying the primary outcome. It is therefore not possible to assess how multiplicity was handled.
What do the planning assumptions represent?
General explanation: sample-size planning explores how many participants may be needed under specified assumptions about the effect to detect, the significance level, allocation, and statistical model. Such planning is not an observed result and does not show that a study had a particular probability of detecting its actual effect. The registry record does not report a sample-size justification for this trial.
The planning illustration associated with the record is described as using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It is explicitly a planning illustration, not the trial's own design: the trial itself is listed as single-group. Any participant counts generated under two-arm assumptions would not describe observed enrollment in this study, nor would they be observed power. The numerical planning estimates are not reported in the registry record.
What statistical plan is documented?
The record identifies the primary outcome, its summary parameter, its dispersion measure, and its timeframe. It does not report the detailed statistical analysis plan, including any adjustment strategy, treatment of missing observations, analysis population, or model. Those details are not reported in the registry record and should not be inferred from the endpoint description alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists five outcome measures and five analyses: the primary BSA endpoint and secondary measures covering GASMI score, Skindex-16 score, CD3e mRNA concentration in skin, and IFN-gamma protein concentration. It identifies the BSA measure as primary, but a procedure for controlling or interpreting multiplicity is not reported in the registry record.
General explanation: examining several outcomes can create multiple opportunities for a result to appear notable by chance. Whether and how this issue is addressed depends on the prespecified analysis strategy, such as prioritizing outcomes or adjusting inference. The record does not report such a strategy, so the significance of any hypothetical pattern across outcomes cannot be evaluated. Numerical results for the listed outcomes are not reported in the registry record in any case.
Handling of missing measurements is not reported in the registry record. The record does not describe how missing baseline or follow-up values were handled, whether any imputation was used, or whether all enrolled participants contributed to each analysis. The analysis population is also not reported in the registry record. Enrollment is listed as 10, but that alone does not establish how many participants were included in each outcome analysis.
The registry record does not report the statistical analysis plan, including model specifications, covariate adjustment, or rules for excluding observations. These omissions limit reproducibility and make it difficult to determine how the listed outcomes would have been analyzed. They should not be filled in by assumptions about common practice.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Abrocitinib 200 mg Daily | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Abrocitinib 200 mg Daily | 0 of 10 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Abrocitinib 200 mg Daily | 9 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Abrocitinib 200 mg Daily |
|---|---|---|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | 5 of 10 |
| Nausea | Gastrointestinal disorders | 4 of 10 |
| Fatigue | General disorders | 1 of 10 |
| Drowsiness | Nervous system disorders | 1 of 10 |
| Headache | Nervous system disorders | 1 of 10 |
| Dizziness | Nervous system disorders | 1 of 10 |
| Eye inflammation | General disorders | 1 of 10 |
| Chalazion | General disorders | 1 of 10 |
For the group titled Abrocitinib 200 mg Daily, the record lists 10 participants at risk for serious adverse events and 0 participants affected. It lists 10 at risk for other adverse events and 9 affected. Deaths are listed as 0. These are participant counts, not rates calculated.
The serious adverse-event count and the other-adverse-event count refer to separate categories in the record. The absence of recorded serious adverse events does not mean that no adverse events occurred: 9 participants are listed as affected by other adverse events. The record does not provide terms for the other events, and the serious adverse-event term list is empty. It therefore does not describe the types of events, their severity beyond the category, their timing, duration, or whether they led to treatment changes.
These figures are descriptive of the 10 participants in this group. With no separate comparator group, they do not show how the counts compare with another treatment or with no treatment. They also should not be taken as a complete characterization of safety. The registry record does not report further detail that would support a more granular assessment.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed phase 2 study enrolled 10 participants with moderate to severe GA and assessed abrocitinib 200 mg daily over 6 months. It identifies percentage BSA involvement by active GA at baseline and 6 months as the primary outcome. It also lists secondary outcomes related to severity and morphology, skin-related quality of life, and skin biomarkers. These details describe the study question and what it set out to measure.
Numerical results for the primary and secondary outcomes are not reported in the registry record. Accordingly, the record does not establish the amount or direction of change in BSA involvement, the variability of measurements, or the precision of an estimated change. Nor does it show numerical changes in the other listed outcomes. The endpoint descriptions should not be mistaken for findings.
The study's single-group structure also matters. A within-group measurement over time, if available, would not supply a randomized estimate of the difference between abrocitinib and a comparator. No comparator group is listed, and masking is recorded as NONE. The observed safety counts likewise have no comparator in this record and lack event-level detail.
These limits do not erase the descriptive value of the study record: it documents the intervention, timeframe, population description, intended outcomes, and recorded adverse-event counts. They do determine what can be concluded from it. The registry record cannot establish a treatment effect or support a comparative conclusion, and it cannot show the precision of the primary outcome. Such claims would require outcome results and, for a comparative treatment effect, an appropriate comparison.
13. Why This Trial Matters Statistically
This trial is statistically notable as a single-group study with a clearly identified continuous primary endpoint and a defined follow-up time. It illustrates the distinction between measuring change in a treated group and estimating a difference attributable to treatment. A baseline-to-follow-up comparison can describe the course observed among participants, but without a comparator it cannot show what would have happened under another condition.
The enrollment of 10 also highlights why numerical estimates and uncertainty matter. The count alone does not reveal the variability of BSA measurements or the precision of an estimated change. Reporting a mean alongside a measure of dispersion, and ideally an interval estimate for the change, would help readers understand the observed data. Those numerical primary outcome results are not reported in the registry record.
The five listed outcome measures also raise an important general issue: a study may assess several distinct dimensions, but their results need to be reported and interpreted in light of their prespecified roles and any multiplicity approach. Here, those results and the multiplicity strategy are not reported in the registry record.
The record's planning illustration is described using assumptions for two equally allocated arms, whereas the actual study is listed as single-group. That contrast is a useful reminder that planning assumptions must match the design they are meant to inform. Such planning estimates are not observed power and do not replace the trial's own design rationale, which is not reported in the registry record.
14. 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 limitations specific to this study follow directly from its registry description. Enrollment was 10, and the study is listed as single-group, with allocation recorded as NA and masking as NONE. No comparator group is listed. These features limit causal and comparative interpretation, even if numerical outcome results were available.
The primary endpoint is identified as percentage BSA involvement by active GA at baseline and 6 months, but numerical primary results are not reported in the registry record. The record therefore does not permit assessment of the observed change, its variability, or its precision. Numerical results for the listed secondary outcomes are also not reported in the registry record.
The record lists five outcome measures and five analyses, but does not report a multiplicity strategy, missing-data handling, or the analysis population. It does not report the detailed statistical plan or a sample-size justification. These gaps make it difficult to assess whether analyses followed a prespecified approach or how incomplete measurements, if any, were handled.
The safety information is limited to participant counts: 0 with serious adverse events, 9 with other adverse events, and 0 deaths among 10 at risk in the listed group. Specific event terms and further details are not reported in the registry record. The record consequently cannot support a detailed comparison of event types, timing, or severity.
These limitations concern what the registry record documents. They do not establish that additional information was never collected; the relevant details are simply not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Janus Kinase Inhibition in Granuloma Annulare — NCT05650736.
- Registry record last updated 2026-10-07; status last verified 2026-09.
- Results first posted 2026-10-07.
- 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.
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18. Record Summary
NCT05650736 is a completed phase 2, single-group study of abrocitinib 200 mg daily for 6 months in 10 participants with moderate to severe GA affecting at least 5% BSA. The primary endpoint was percentage BSA involvement by active GA at baseline and 6 months. The registry record lists four secondary outcomes concerning GA severity and morphology, skin-related quality of life, and skin biomarkers.
The record lists 0 participants with serious adverse events, 9 with other adverse events, and 0 deaths among 10 at risk. Numerical primary and secondary outcome results, detailed analysis methods, missing-data handling, multiplicity procedures, and a sample-size justification are not reported in the registry record. With no comparator group listed, the design does not provide a randomized treatment comparison.