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 Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects. (NCT04015232), a randomized phase 1 study. The primary outcome is Immunogenicity Screening Incidence to Detect the Presence of Anti-PegG-CSF Antibodies..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04015232 |
| Phase | Phase 1 |
| Condition | Immunogenicity, Healthy Volunteers |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 200 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Intas Pharmaceuticals, Ltd. |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adult human subjects under fed conditions. The registry record lists an enrollment of 200 and identifies healthy volunteers as a study condition. It does not report participant characteristics such as age distribution, sex, or other baseline features.
Intervention
INTP5, the proposed pegfilgrastim biosimilar from Intas Pharmaceuticals Ltd., administered subcutaneously at 6 mg/0.6 mL. The study description refers to multiple doses; the sampling schedule identifies a pre-dose sample before a second dose.
Comparator
US Neulasta, the reference product, administered subcutaneously at 6 mg/0.6 mL. Both products were compared in a randomized, parallel, two-treatment design.
Primary question
What was the incidence of screening-assay positivity for anti-PegG-CSF antibodies in samples collected during the study? The registry describes the primary outcome as a count of participants and says that immunogenicity data were analyzed descriptively. Numerical primary-outcome results by treatment are not reported in the registry record, so the comparative result cannot be determined from that record.
3. Trial Design
This was a phase 1, randomized, assessor-blind, balanced, parallel study of two treatments. It compared INTP5 with US Neulasta in healthy adults under fed conditions. Both products were administered subcutaneously at 6 mg/0.6 mL. The registry lists an enrollment of 200, and the study status is completed.
The study start date was 2018-02-26, and the primary completion date was 2018-06-05. The record describes the study as a comparative immunogenicity study of multiple doses. Its sampling schedule includes a sample collected before the second dose, as well as screening, pre-dose, and later post-dose samples. The recorded time points extend through 2016 hours after the first dose. The registry does not report the number of participants who received each dose or the number who completed follow-up.
“Randomized” means treatment allocation was assigned by chance, while “parallel” means participants were assigned to one treatment group rather than crossing between treatments. “Assessor-blind” indicates that assessment was masked, but the registry record does not specify which people were blinded or whether participants or treatment staff were masked. It describes the study as balanced but does not report the actual allocation process or a detailed allocation ratio in the design fields.
The registry lists pharmacokinetic outcomes, including measures of concentration and exposure, as secondary outcomes. The reported primary outcome concerns screening for anti-PegG-CSF antibodies. The record does not state the sample-size justification, the statistical analysis plan, or whether any interim analyses were planned.
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 | INTP5 Biosimilar Product | US Neulasta Reference Product |
|---|---|---|
| STARTED | 100 | 100 |
| COMPLETED | 89 | 93 |
| NOT COMPLETED | 11 | 7 |
Reasons for not completing this period:
| Reason | INTP5 Biosimilar Product | US Neulasta Reference Product |
|---|---|---|
| Withdrawal by Subject | 7 | 4 |
| Protocol Violation | 1 | 0 |
| Medical Grounds | 3 | 3 |
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 | INTP5 Biosimilar Product | US Neulasta Reference Product | Total |
|---|---|---|---|---|
| Participants analysed | 100 | 100 | 200 | |
| Age, Continuous | years | 31.5 (SD 6.82) | 34.3 (SD 6.05) | 32.9 (SD 6.58) |
| Sex: Female, Male: Female | Participants | 40 | 40 | 80 |
| Sex: Female, Male: Male | Participants | 60 | 60 | 120 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 100 | 100 | 200 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: India | Participants | 100 | 100 | 200 |
| Height | cm | 160.2 (SD 8.48) | 160.1 (SD 8.68) | 160.2 (SD 8.56) |
| Weight | kg | 61.3 (SD 8.31) | 62.6 (SD 7.49) | 61.9 (SD 7.92) |
| BMI | kg/m^2 | 23.95 (SD 3.069) | 24.51 (SD 3.266) | 24.23 (SD 3.173) |
6. Primary Endpoint
The registry lists the primary outcome as Immunogenicity Screening Incidence to Detect the Presence of Anti-PegG-CSF Antibodies., measured over Samples (8 mL each) were withdrawn at screening, at pre-dose and at 336 (D-15, Week 2), 504 (D-22, Week 3, within 60 minutes before 2nd dose), 840 (D-36, Week 5), 1176 (D-50, Week 7), 1680 (D-71, Week 10) and 2016 (D-85, Week 12) hours after first dose..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is the incidence of screening-assay positivity for anti-PegG-CSF antibodies. The registry defines it as a count of participants and describes sampling at screening, before dosing, and at scheduled times after the first dose, including a sample before the second dose. The stated purpose of the screening assay is to identify samples that may contain antibodies directed against pegfilgrastim-related targets.
Immunogenicity monitoring is used to detect an antibody response to a biologic product. A screening assay is an initial step: according to the registry description, samples that screen positive proceed to confirmatory testing. Further tiers assess antibody specificity, antibody titer, and, for samples positive in confirmatory assays, neutralizing activity. These later tests answer different questions from the initial screening result. A positive screening result alone does not establish specificity or neutralizing capacity.
The registry says that immunogenicity data were presented for all subjects’ collected samples and that the analysis was descriptive. It also states that an incidence within + 10% of the expected 6% ADA positivity incidence for the test product was not considered clinically significant. This is a criterion described in the record, not a reported finding. The actual counts or rates of screening-positive participants, confirmatory results, titers, and neutralizing antibodies are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary question as whether screening assays detected anti-PegG-CSF antibodies in study samples. It describes the sampling schedule and the tiered testing process, but does not report the numerical primary-outcome results by treatment. Consequently, no treatment comparison for screening positivity can be drawn from the record. The stated expectation of 6% ADA positivity for the test product and the stated interpretation threshold are contextual details, not observed trial results.
The registry lists 17 outcome measures and identifies pharmacokinetic endpoints among the secondary outcomes. It reports zero analyses in its analysis listing. That does not establish that no analysis was performed; it means the registry record does not contain analysis entries from which to inspect estimates, uncertainty, or statistical tests. No confidence intervals, p-values, or treatment-effect estimates for the immunogenicity endpoint are reported in the registry record.
The safety counts are separate from the primary immunogenicity outcome. Serious adverse events affected 0 of 100 participants in the INTP5 group and 1 of 100 in the US Neulasta group. The record also lists other adverse events affecting 32 of 100 and 37 of 100 participants, respectively. It records one death in the US Neulasta group and none in the INTP5 group. These are descriptive counts, not evidence that a treatment caused or prevented an event. The registry does not report event attribution, timing, or detailed individual clinical circumstances.
Because the registry does not include the primary endpoint counts or comparative estimates, the precision of the immunogenicity comparison cannot be assessed. There is no reported interval around an effect estimate to indicate the range of values compatible with the observed data. Nor can the reported safety counts alone establish a difference between groups: sparse serious events provide little information about comparative rates, and the record does not give an inferential safety analysis.
The study’s randomized, assessor-blind design identifies the intended comparison, but design features do not substitute for the outcome data needed to interpret that comparison. The registry establishes what was studied and how the primary outcome was defined. It does not supply enough result information to judge the observed comparative immunogenicity or its statistical uncertainty.
9. Statistical Methods Explained
What does randomization contribute?
In general, random allocation is intended to make treatment groups comparable with respect to both measured and unmeasured participant characteristics, on average. This supports a fair comparison, though it does not guarantee identical groups in any particular study. Randomization is most informative when participant flow, outcomes, and analysis populations are reported clearly. The registry identifies this study as randomized but does not report the sequence-generation method, allocation concealment details, or group-specific baseline characteristics.
What does assessor-blind mean?
In general, masking an outcome assessor can reduce the chance that knowledge of treatment assignment influences outcome measurement or interpretation. The record calls the study assessor-blind, but does not specify which assessors were masked or whether participants, dosing staff, or laboratory personnel were also masked. Antibody testing uses laboratory assays, yet the registry description does not state how laboratory blinding was handled.
How should a binary outcome be understood?
In general, a binary outcome classifies each participant into one of two states for a defined endpoint, such as screening positive or screening negative. A count of participants with an event is a direct description of how many met the definition. A rate or treatment contrast requires both the event count and the relevant group denominator, with clear rules for handling repeated samples, missing measurements, and participants who leave the study. The registry identifies the primary measure as a participant count but does not report the treatment-specific positive counts or explain how multiple samples from one participant contributed to the participant-level outcome.
Why use a tiered antibody assessment?
In general, tiered immunogenicity testing separates screening from confirmation and characterization. A screening assay is designed to identify samples for further assessment; confirmation evaluates whether a signal is specific, and titer testing describes the amount of antibody detected. A neutralizing-antibody assay addresses whether detected antibodies can inhibit product activity in the assay. These stages should not be treated as interchangeable endpoints. The registry describes all four steps, but does not report their numerical results.
What does a confidence interval tell a reader?
In general, a confidence interval expresses the statistical uncertainty around an estimated quantity under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while an interval that includes values compatible with different interpretations can leave the comparison uncertain. A confidence interval does not correct bias, resolve missing-data problems, or establish that an endpoint is clinically important. No confidence interval for the primary immunogenicity comparison is reported in the registry record.
Why do analysis details matter?
In general, the analysis method should match the outcome type and the study question. For participant counts, an analysis may compare proportions or model event status, but the choice, adjustments, and handling of sparse data should be specified in advance and reported. The registry describes the immunogenicity analysis as descriptive. It does not report a prespecified inferential method, adjustment variables, treatment-effect measure, or uncertainty calculation. The analysis plan is not reported in the registry record.
The registry lists pharmacokinetic measures such as maximum concentration, area under the concentration-time curve, time to maximum concentration, and elimination-related parameters as secondary outcomes. In general, pharmacokinetic comparisons require clear definitions of the estimand, analysis population, transformations or model, and treatment-comparison interval. The record lists these endpoint types but does not report numerical estimates or the methods used to analyze them.
The record’s sample-size description characterizes a planning illustration based on the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence of the probability that a result is true. Because the registry does not report the primary endpoint result or a trial-specific sample-size justification, the illustration cannot establish the study’s original design rationale or the precision achieved for immunogenicity.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 17 outcome measures, including the primary immunogenicity screening outcome and several pharmacokinetic measures. When a study evaluates multiple outcomes, time points, or antibody-testing tiers, there can be multiple opportunities to identify a result that appears notable by chance. In general, a statistical analysis plan may identify a primary comparison, distinguish confirmatory from exploratory outcomes, and specify whether or how multiplicity is addressed. The multiplicity strategy is not reported in the registry record.
The primary outcome description includes multiple sample-collection times, and the antibody assessment is tiered. The record explains which assay stages follow a positive screening result, but it does not report whether the primary endpoint was a participant-level summary across visits, a visit-specific comparison, or another prespecified rule. It also does not report how repeated positive or negative results were handled in the analysis.
Missing-data procedures and analysis populations are not reported in the registry record. The record does not state how missing samples, unevaluable assays, withdrawals, or protocol deviations were handled. It also does not identify an intention-to-treat, per-protocol, safety, or pharmacokinetic analysis population. These details matter because inclusion rules and missing-data assumptions can affect the population represented by an estimate.
The registry lists zero analysis entries. This is a limitation of the registered information, not proof that no statistical work took place. Without a reported analysis plan, multiplicity procedure, missing-data approach, or population definition, readers cannot assess whether the posted outcome presentation follows prespecified methods.
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 |
|---|---|---|---|
| INTP5 Biosimilar Product | 0 | 100 | 0.0% |
| US Neulasta Reference Product | 1 | 100 | 1.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| INTP5 Biosimilar Product | 0 of 100 |
| US Neulasta Reference Product | 1 of 100 |
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 |
|---|---|
| INTP5 Biosimilar Product | 32 of 100 |
| US Neulasta Reference Product | 37 of 100 |
Most frequent serious adverse event terms
| Event term | Organ system | INTP5 Biosimilar Product | US Neulasta Reference Product |
|---|---|---|---|
| death | General disorders | 0 of 100 | 1 of 100 |
Most frequent non-serious adverse event terms
| Event term | Organ system | INTP5 Biosimilar Product | US Neulasta Reference Product |
|---|---|---|---|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 16 of 100 | 15 of 100 |
| Headache | Nervous system disorders | 6 of 100 | 13 of 100 |
| Vomiting | Gastrointestinal disorders | 5 of 100 | 5 of 100 |
| Injection site pain | General disorders | 5 of 100 | 4 of 100 |
| Injury | Injury, poisoning and procedural complications | 0 of 100 | 3 of 100 |
| Red blood cells urine positive | Investigations | 3 of 100 | 0 of 100 |
| Diarrhoea | Gastrointestinal disorders | 0 of 100 | 2 of 100 |
| Pyrexia | General disorders | 2 of 100 | 0 of 100 |
| Hyperbilirubinaemia | Hepatobiliary disorders | 1 of 100 | 1 of 100 |
| Protein urine present | Investigations | 1 of 100 | 1 of 100 |
Serious events with the highest arm-level rate: death (1.0%).
The registry reports serious adverse events among 100 participants at risk in each group. The INTP5 group had 0 participants with a serious adverse event; the US Neulasta group had 1. It lists death as the top serious event term at 1.0%. The record also reports other adverse events affecting 32 of 100 participants in the INTP5 group and 37 of 100 in the US Neulasta group.
These are counts from the registry record, not estimates of causation. The record does not state whether the death was considered related to treatment, give its clinical circumstances, or describe timing. It also does not provide event-level details for the other adverse events or a comparative statistical analysis. A participant count does not show how many total events occurred, whether a participant had more than one event, or how long participants were observed for safety.
Serious adverse events are distinct from the broader category of other adverse events. The available counts should therefore be read by category rather than combined. With only one serious event listed, the descriptive group counts alone do not establish a reliable treatment difference or rule out uncommon harms.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, assessor-blind, parallel phase 1 study compared INTP5 and US Neulasta in healthy adults under fed conditions. It describes subcutaneous dosing at 6 mg/0.6 mL and a primary immunogenicity outcome based on screening for anti-PegG-CSF antibodies. It also describes subsequent confirmatory, titer, and neutralizing-antibody testing, and lists pharmacokinetic endpoints.
However, the registry record does not report the numerical primary outcome by treatment. It therefore cannot show how many participants screened positive, whether results differed between groups, or how precise a comparative estimate might be. The expected 6% test-product incidence and the record’s stated threshold are not substitutes for observed results. The listed safety counts provide descriptive information but do not establish cause, comparative risk, or absence of risk.
These limitations mean the registry record alone cannot support a conclusion about comparative immunogenicity. It also cannot establish equivalence, noninferiority, or similarity: those conclusions require an appropriate estimand, prespecified margins where relevant, suitable analysis methods, and results with uncertainty estimates. None of those comparative results or analysis details are reported in the registry record.
The study’s healthy-adult population and phase 1 design also define the scope of its question. The registry record does not establish how findings would apply to other populations or settings. It should be read as a description of the study and of the limited results recorded, not as a complete account of all analyses or a basis for treatment decisions.
13. Why This Trial Matters Statistically
This trial is statistically notable because its primary question concerns immunogenicity, but the registry identifies the outcome as a screening count and describes a multi-stage antibody-assessment process. Keeping those levels distinct matters: screening positivity is not the same as confirmed specificity, titer, or neutralizing activity. A single headline count cannot represent every stage of that assessment.
The study is randomized and assessor-blind, features that can support a comparative design. Yet interpretability also depends on reporting the actual group outcomes, the analysis population, how repeated samples were summarized, and the uncertainty around comparisons. Those details are not reported for the primary endpoint in the registry record. The contrast between a clearly described endpoint process and absent numerical comparative results illustrates why design information alone cannot answer an effectiveness or similarity question.
The registry also lists pharmacokinetic outcomes and safety counts alongside immunogenicity. These outcomes answer different questions and should not be combined into a single judgment. Their multiplicity calls for transparent distinctions between primary, secondary, and exploratory analyses, while sparse serious-event counts require particular caution in interpretation.
For biostatisticians and clinical researchers, the record highlights the value of complete registry reporting: outcome definitions, participant flow, analysis populations, prespecified methods, missing-data handling, and estimates with uncertainty. Without these elements, readers may know what investigators intended to measure but lack the information needed to evaluate the comparative result.
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 principal trial-specific limitation in the registry record is that it does not report numerical results for the primary immunogenicity outcome by group. Although the endpoint definition and sampling schedule are detailed, the screening-positive counts, comparative estimate, and uncertainty are absent. Numerical findings for confirmatory, titer, and neutralizing-antibody assays are also not reported in the registry record.
The record does not report participant flow, group-specific completion, withdrawals, baseline characteristics, or the number of samples successfully evaluated. It does not explain how multiple time points were reduced to a participant-level outcome or how missing, unevaluable, or repeated assay results were handled. Analysis populations and a statistical analysis plan are not reported in the registry record.
The assessor-blind designation is not accompanied by details identifying who was masked. Allocation concealment, randomization procedures, and laboratory blinding are also not described. The record does not report a trial-specific sample-size justification, the intended precision for the immunogenicity comparison, or interim-analysis plans.
Safety reporting is limited to group counts for serious and other adverse events, plus a serious-event term of death. Attribution, event timing, severity details beyond the category, and individual event narratives are not reported. The study enrolled healthy adults under fed conditions, so the registry record does not establish the relevance of its findings to populations or circumstances outside that study description.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Comparative Immunogenicity Study of Multiple Doses of Proposed Pegfilgrastim Biosimilar, INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects. — NCT04015232.
- Registry record last updated 2019-10-04; status last verified 2019-09.
- Results first posted 2019-10-04.
- 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
NCT04015232 is a completed, randomized, assessor-blind, parallel phase 1 comparison of INTP5 and US Neulasta in healthy adults under fed conditions. The registry lists enrollment of 200, subcutaneous doses of 6 mg/0.6 mL for both products, a start date of 2018-02-26, and a primary completion date of 2018-06-05.
The primary outcome is screening incidence for anti-PegG-CSF antibodies, with confirmatory, titer, and neutralizing-antibody testing described as later assay stages. Pharmacokinetic measures are listed as secondary outcomes. Numerical primary immunogenicity results and comparative estimates are not reported in the registry record. Safety counts include 0 serious adverse events among 100 participants in the INTP5 group and 1 among 100 in the US Neulasta group; the record also lists 32 and 37 participants with other adverse events, respectively.