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 Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Repeat Doses of GSK2982772 in Subjects With Psoriasis (NCT02776033), a randomized phase 2 study. The primary outcome is Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02776033 |
| Phase | Phase 2 |
| Condition | Psoriasis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 65 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
People with active plaque-type psoriasis. The study’s safety population included participants who received at least one dose of study treatment.
Intervention
Oral GSK2982772, given as 60 mg twice daily in Cohort 1 or 60 mg three times daily in Cohort 2. Treatment continued for 84 days.
Comparator
Matching placebo on the corresponding twice-daily or three-times-daily schedule. Participants were randomized within the study’s two cohorts.
Primary question
How many participants had serious or non-serious adverse events through Day 116? The registry identifies this as the primary outcome, with safety assessed in participants who received at least one dose.
The trial also assessed pharmacokinetics, pharmacodynamics, and clinical or tissue-based measures related to psoriasis. These included plasma concentrations, lesional biopsy findings, inflammatory gene expression, and psoriasis lesion severity scores. Those outcomes provide a broader account of what the investigators planned to examine, but the available record does not include numerical results for them.
The primary question is about the number of participants with adverse events, not a single measure of psoriasis improvement. The registry reports serious and non-serious event counts by treatment group, but it does not report an adjusted treatment effect, a confidence interval, or a statistical test for this outcome. The posted information therefore supports a descriptive reading of the recorded counts rather than a definitive comparison of the treatment schedules with placebo.
3. Trial Design
This was a randomized, double-blind, parallel-group, placebo-controlled Phase 2 study sponsored by GlaxoSmithKline. The registry describes the masking as double, with the sponsor unblinded. It lists 65 participants enrolled and the study status as completed. The study began on 2016-08-30, with primary completion on 2018-01-04.
The study had two cohorts with different dosing schedules. In Cohort 1, participants were randomized to oral GSK2982772 60 mg twice daily or placebo twice daily for 84 days. In Cohort 2, participants were randomized to oral GSK2982772 60 mg three times daily or placebo three times daily for 84 days. The schedule descriptions specify approximately 12 hours between twice-daily doses and approximately 8 hours between three-times-daily doses. The brief summary describes screening of up to 30 days and follow-up for 28 days after treatment; total participation was described as approximately 20 weeks from screening to the final study visit.
The two active schedules should be read as separate treatment comparisons against their corresponding placebo schedules. They are not described as a direct randomized comparison of twice-daily against three-times-daily dosing. The brief summary gives approximate planned cohort sizes, but the registry information presented for the safety outcome gives the actual group-specific numbers assessed for that outcome.
The primary outcome was the number of participants with serious adverse events and non-serious adverse events through Day 116. The registry lists 18 outcome measures overall, including secondary measures of drug concentrations and psoriasis-related tissue and lesion assessments. It does not report the statistical analysis plan, allocation ratios, sequence-generation details, or a sample-size justification 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.
Before assignment: A total of 100 participants were screened, of which, 65 participants were enrolled in the study.
Overall Study
| Stage | Placebo | GSK2982772 60 mg BID | GSK2982772 60 mg TID |
|---|---|---|---|
| STARTED | 18 | 23 | 24 |
| COMPLETED | 14 | 21 | 22 |
| NOT COMPLETED | 4 | 2 | 2 |
Reasons for not completing this period:
| Reason | Placebo | GSK2982772 60 mg BID | GSK2982772 60 mg TID |
|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 2 |
| Physician Decision | 2 | 0 | 0 |
| Lost to Follow-up | 1 | 0 | 0 |
| Adverse Event | 1 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety Population
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 | Placebo | GSK2982772 60 mg BID | GSK2982772 60 mg TID | Total |
|---|---|---|---|---|---|
| Participants analysed | 18 | 23 | 24 | 65 | |
| Age, Continuous | Years | 47.1 (SD 14.95) | 44.6 (SD 12.52) | 47.5 (SD 13.41) | 46.3 (SD 13.40) |
| Sex: Female, Male: Female | Participants | 5 | 6 | 5 | 16 |
| Sex: Female, Male: Male | Participants | 13 | 17 | 19 | 49 |
| Race/Ethnicity, Customized: Asian - Central/South Asian Heritage | Participants | 2 | 1 | 2 | 5 |
| Race/Ethnicity, Customized: Asian - East Asian Heritage | Participants | 1 | 1 | 0 | 2 |
| Race/Ethnicity, Customized: Asian - South East Asian Heritage | Participants | 1 | 1 | 1 | 3 |
| Race/Ethnicity, Customized: Native Hawaiian or other Pacific Islander | Participants | 0 | 0 | 1 | 1 |
| Race/Ethnicity, Customized: White - Arabic/North African Heritage | Participants | 1 | 1 | 1 | 3 |
| Race/Ethnicity, Customized: White - White/Caucasian/European Heritage | Participants | 13 | 19 | 19 | 51 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs, measured over Up to Day 116.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants who experienced serious adverse events (SAEs) and non-serious adverse events (non-SAEs), with the stated timeframe extending through Day 116. The registry defines an adverse event as an untoward medical occurrence temporally associated with use of a medicinal product, whether or not the event is considered related to that product. An SAE is an event meeting specified seriousness criteria, including death, life-threatening events, hospitalization or prolonged hospitalization, disability or incapacity, congenital anomaly or birth defect, liver injury with impaired liver function, or other circumstances judged serious on medical or scientific grounds.
This is a safety endpoint: it describes how many participants had events during the observation period. Counting participants is useful for distinguishing the number of people affected from the number of event episodes, since a participant may have more than one event. The registry outcome is stated as participant counts and does not provide a total number of event episodes in the registry record.
The safety population is defined as participants who received at least one dose of study treatment. That population definition matters because it is tied to exposure to treatment, rather than simply to randomization. The endpoint does not, by itself, establish whether an event was caused by treatment. The registry definition explicitly includes events whether or not they are considered related to the medicinal product, and the posted counts do not provide an adjusted causal estimate.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety counts are descriptive. For serious adverse events, the registry reports 0 of 18 participants in the placebo group, 1 of 23 in the GSK2982772 60 mg twice-daily group, and 1 of 24 in the GSK2982772 60 mg three-times-daily group. For non-serious adverse events, the corresponding counts are 8 of 18, 21 of 23, and 16 of 24. These figures describe participants with at least one event in each recorded category; they do not give the number of separate event episodes.
The registry also reports deaths separately: 0 in the placebo group, 1 in the twice-daily group, and 0 in the three-times-daily group. The record does not provide enough detail in the registry record to characterize the circumstances, cause, or relationship to study treatment for the death. The serious adverse event count should not be interpreted as a treatment-attributable count: the endpoint definition includes events regardless of whether they were considered related to the medicinal product.
These are small group-specific counts, so a difference in the observed numbers alone cannot establish that the underlying event risks differ. A confidence interval would express the uncertainty around an estimated effect; the registry record does not report one for these counts. It also does not report a statistical test or adjusted estimate. The posted data therefore do not establish a statistically supported difference between GSK2982772 and placebo, nor do they establish equivalence or absence of a difference.
The two active groups used different dosing schedules and were studied in separate cohorts. Each should be interpreted against its corresponding placebo group rather than treated as a direct comparison between the active schedules. The registry does not report a direct statistical comparison between twice-daily and three-times-daily dosing.
The serious-event terms listed among the most frequent include accidental overdose at 4.3% and procedural hypertension at 4.2%. The record excerpt does not specify the denominators or treatment groups associated with these percentages, so they should not be assigned to a particular arm or used to infer a group-specific rate. No numerical results for the listed pharmacokinetic, pharmacodynamic, biopsy, gene-expression, or lesion-severity outcomes are included in the registry record. Conclusions about those outcomes cannot be drawn from the safety counts.
9. Statistical Methods Explained
The primary outcome is a count of participants with events. For this type of outcome, each participant is classified according to whether the specified event category occurred during the stated observation period. The posted results distinguish serious from non-serious adverse events and report the number at risk and the number affected for each group. Those counts are directly interpretable as descriptive summaries, but they do not alone quantify the uncertainty around a difference between groups.
What does a confidence interval add?
In general, a confidence interval presents a range of values compatible with the observed data under a specified statistical method. For a treatment comparison, it helps show the precision of an estimated difference or ratio, rather than relying only on whether a statistical test crosses a threshold. A wide interval indicates that the data leave substantial uncertainty about the size or direction of an effect. The registry record does not report confidence intervals or an estimated comparative effect for this primary outcome.
Why is a count not the same as an event rate?
A participant count answers how many people experienced an event within a group. An event rate may instead use the number of event episodes or time at risk as its basis. Those quantities are not interchangeable: one person can have repeated events, and follow-up time can vary. The primary outcome is defined as a count of participants, and the record does not report the total number of event episodes or a person-time analysis for this outcome. The observed counts should therefore be described as numbers of participants affected, not as episode rates.
Why keep the cohorts separate?
The trial used two dosing schedules: twice daily in Cohort 1 and three times daily in Cohort 2. Each schedule had its own placebo group. A comparison within a cohort addresses the active schedule against its corresponding placebo, while a comparison between active schedules would be a different question. The registry record does not report a direct statistical comparison of the two active schedules. Combining the groups without an analysis plan could obscure the distinct schedules and cohort comparisons, so the posted group counts are best described as recorded.
What do randomization and masking contribute?
In general, randomization aims to make treatment groups comparable at the point of assignment, while masking can reduce the influence of treatment knowledge on participant behavior or outcome assessment. The registry identifies the study as randomized and double-blind, with the sponsor unblinded. The registry record does not describe the randomization sequence, concealment procedures, or which roles remained masked, so those details cannot be evaluated from the available information.
How should the planning calculations be read?
In general, sample-size calculations are design illustrations: they estimate the number of participants needed under specified assumptions to detect a chosen effect with a chosen level of statistical power. They are not a measure of the probability that a trial result is true, and they are not observed power. The planning assumptions described for this study use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. For non-time-to-event calculations, results are expressed as participants per arm; time-to-event calculations use a total number of events. The registry record does not report a sample-size justification for the trial’s original design. Any planning illustration should therefore be read as a hypothetical calculation under its stated assumptions, not as evidence that the study was designed to detect a particular safety difference.
Statistical methods can also account for features such as over-dispersion, which occurs when observed variability exceeds what a simple model assumes. In general, ignoring over-dispersion can make uncertainty appear too small. The registry record does not state whether any such model or adjustment was used. It also does not report the analysis model, covariate adjustments, hypothesis-testing procedure, or a prespecified approach for handling multiple outcomes for the primary safety result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary safety outcome and 18 outcome measures overall, including secondary pharmacokinetic, pharmacodynamic, biopsy, gene-expression, and lesion-severity measures. When many outcomes are assessed, the chance of observing an apparently notable result by chance can increase if each is tested separately. In general, multiplicity procedures can control that risk, for example by adjusting testing thresholds or defining a hierarchy of outcomes. The multiplicity strategy for this study is not reported in the registry record. The registry record lists no analysis entries, so it does not provide a set of inferential results or a documented testing strategy to assess.
The primary endpoint is described for the safety population, defined as all participants who received at least one dose of study treatment. The posted safety counts give group-specific numbers at risk and affected. The registry does not explain how participants with incomplete observation, missing event information, or early discontinuation were handled, or whether any imputation or sensitivity analysis was used. Missing-data procedures are not reported in the registry record.
The registry identifies randomization and double masking, with sponsor unblinding, but it does not report an intention-to-treat analysis population or other analysis populations for efficacy outcomes. Nor does it describe how participants were handled in analyses if they did not follow the assigned schedule. The registry entries therefore support interpretation of the safety population counts, but not assumptions about the analysis populations or missing-data methods for other endpoints.
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 |
|---|---|---|---|
| Placebo | 0 | 18 | 0.0% |
| GSK2982772 60 mg BID | 1 | 23 | 4.3% |
| GSK2982772 60 mg TID | 1 | 24 | 4.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 18 |
| GSK2982772 60 mg BID | 1 of 23 |
| GSK2982772 60 mg TID | 0 of 24 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 8 of 18 |
| GSK2982772 60 mg BID | 21 of 23 |
| GSK2982772 60 mg TID | 16 of 24 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | GSK2982772 60 mg BID | GSK2982772 60 mg TID |
|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | 0 of 18 | 1 of 23 | 0 of 24 |
| Procedural hypertension | Injury, poisoning and procedural complications | 0 of 18 | 0 of 23 | 1 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | GSK2982772 60 mg BID | GSK2982772 60 mg TID |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 4 of 18 | 7 of 23 | 7 of 24 |
| Headache | Nervous system disorders | 4 of 18 | 10 of 23 | 3 of 24 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0 of 18 | 1 of 23 | 2 of 24 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 18 | 0 of 23 | 1 of 24 |
| Cough | Respiratory, thoracic and mediastinal disorders | 0 of 18 | 2 of 23 | 1 of 24 |
| Diarrhoea | Gastrointestinal disorders | 2 of 18 | 1 of 23 | 0 of 24 |
| Fatigue | General disorders | 0 of 18 | 3 of 23 | 0 of 24 |
| Nausea | Gastrointestinal disorders | 1 of 18 | 1 of 23 | 1 of 24 |
| Upper respiratory tract infection | Infections and infestations | 0 of 18 | 2 of 23 | 1 of 24 |
| Dizziness | Nervous system disorders | 0 of 18 | 2 of 23 | 0 of 24 |
Serious events with the highest arm-level rate: accidental overdose (4.3%), procedural hypertension (4.2%).
Read the safety figures as counts of participants affected within each recorded group. For serious adverse events, the registry reports 0 of 18 in the placebo group, 1 of 23 in the GSK2982772 60 mg twice-daily group, and 1 of 24 in the GSK2982772 60 mg three-times-daily group. For non-serious adverse events, it reports 8 of 18, 21 of 23, and 16 of 24, respectively. These categories are reported separately; the registry does not provide a combined count of participants with either category.
The death counts are reported separately as 0, 1, and 0 in the same group order. The record does not describe the death’s circumstances or relationship to treatment in the registry record for this analysis. The event terms listed as most frequent include accidental overdose at 4.3% and procedural hypertension at 4.2%, but the associated denominators and treatment groups are not reported in the registry record. These percentages should not be read as arm-specific figures.
Counts do not indicate causation, comparative risk, or statistical uncertainty on their own. The registry’s adverse-event definition includes events whether or not considered related to treatment.
12. What the Result Does, and Does Not, Mean
The registry offers a descriptive account of adverse events among participants in the safety population, alongside the study’s randomized, placebo-controlled design and two dosing schedules. It documents how many participants in each group were recorded as having serious and non-serious adverse events through the stated observation period. It also identifies deaths separately and lists selected serious-event terms with percentages whose group-specific denominators are not stated in the record excerpt.
These observations do not establish that GSK2982772 caused any particular event, or that the observed counts represent a difference in underlying risk. The endpoint definition includes events whether or not they are considered related to the medicinal product. The record does not provide an inferential comparison, confidence intervals, or a statistical test for the primary outcome. Accordingly, the counts should not be treated as proof of a treatment effect, proof of no treatment effect, or evidence that the treatment groups are equivalent.
The study also measured or planned to measure drug concentrations, biological responses, biopsy features, gene expression, and lesion severity. The outcome titles describe those areas, but numerical findings for them are not reported in the registry record used for this analysis. No conclusion about efficacy or changes in psoriasis can be drawn from the safety counts alone.
More broadly, the study’s completed status and its enrollment figure do not resolve the uncertainty in these outcome comparisons. The registry record does not report the analysis methods needed to interpret statistical precision, the handling of missing observations, or the multiplicity approach across outcomes. The appropriate conclusion is limited to the posted descriptive safety counts and the information the registry provides about the design.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint definitions and analysis populations matter when reading a clinical study. Its primary outcome counts participants with serious and non-serious adverse events, while defining the safety population as those who received at least one dose. That makes the denominator part of the interpretation: the posted counts are tied to exposure and to the group-specific numbers at risk, not simply to the overall enrollment figure.
The parallel design also requires attention to the two cohort schedules. Twice-daily and three-times-daily regimens were studied against corresponding placebo schedules. Treating these as separate cohort comparisons avoids implying that the study directly tested one active schedule against the other. The registry does not report such a direct comparison.
The study also demonstrates a distinction between reporting outcomes and reporting inferential analyses. The registry lists safety and a range of pharmacokinetic, pharmacodynamic, tissue, and clinical outcomes, but no analysis entries are listed in the record. Outcome titles show what was assessed; they do not provide effect estimates or uncertainty. A reader needs results and methods—not endpoint names alone—to judge the strength and precision of evidence.
Finally, sparse serious-event counts are especially hard to interpret as comparative evidence. General statistical reasoning indicates that small counts can leave substantial uncertainty, even when the observed numbers differ. The record provides neither confidence intervals nor hypothesis tests for the primary outcome. This makes the trial a useful case for separating observed counts from claims about treatment-related risk, statistical significance, or efficacy.
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.
The registry information supports only a limited interpretation of this trial’s results. It gives safety counts by group but does not report a comparative effect estimate, confidence interval, or statistical test for the primary outcome. The record also lists no analysis entries. As a result, the precision of the observed comparisons and the analysis choices behind them cannot be assessed.
The group sizes reported for the safety outcome are modest, and the serious-event counts are sparse. Such counts may provide limited information about less common events; this is a general limitation of interpreting safety outcomes from small groups, not a claim about an unreported event. The registry does not report a sample-size justification, so whether the original design was intended to address a particular safety difference is not reported in the registry record.
The two active schedules occurred in separate cohorts, and no direct comparison between them is reported. The masking description indicates double blinding with sponsor unblinding, but operational details about who was masked and how the randomization sequence was generated are not reported. Missing-data handling, analysis populations beyond the stated safety population, and multiplicity procedures are also not reported in the registry record.
Although the registry lists multiple biological and clinical outcome measures, the registry entries available for this analysis contain no numerical findings for those outcomes. The serious-event terms with percentages lack reported group-specific denominators. These gaps prevent interpretation of those outcome results and limit conclusions to the descriptive safety counts and design details that are recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Repeat Doses of GSK2982772 in Subjects With Psoriasis — NCT02776033.
- Registry record last updated 2020-07-08; status last verified 2020-06.
- Results first posted 2019-08-22.
- 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
The registry describes a completed, randomized, double-blind, parallel-group, placebo-controlled Phase 2 study of GSK2982772 in people with active plaque-type psoriasis. It lists 65 enrolled participants and a primary safety outcome of serious and non-serious adverse events through Day 116, assessed in the safety population.
Participants in Cohort 1 received GSK2982772 60 mg twice daily or placebo; participants in Cohort 2 received GSK2982772 60 mg three times daily or placebo. Each treatment period lasted 84 days. The posted safety figures include group-specific participant counts with serious and non-serious adverse events and separate death counts. The record lists 18 outcome measures overall, but no analysis entries. Comparative estimates, uncertainty intervals, missing-data methods, and the multiplicity approach are not reported in the registry record.