Comparison · NCT06203457-5e6d7759
Efgartigimod-Efgartigimod vs Placebo-Efgartigimod: Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Efgartigimod-Efgartigimod vs Placebo-Efgartigimod: Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period. Trial comparisons, record NCT06203457-5e6d7759. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06203457-5e6d7759
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.353 | 0.173 | 0.587 | wilson | |
| Risk in group 2 | 0.571 | 0.25 | 0.842 | wilson | |
| Risk difference, group 1 minus group 2 | -0.218 | -0.543 | 0.179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.618 | 0.249 | 1.53 | log | |
| Odds ratio, group 1 over group 2 | 0.409 | 0.0678 | 2.47 | log | |
| Number needed to treat, for one fewer participant with the outcome on Efgartigimod-Efgartigimod than on Placebo-Efgartigimod | 4.58 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Efgartigimod-Efgartigimod | Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study.~This reporting group presents the participants who also received efgartigimod in the parent study (ARGX-113-2106). | 6 | 17 | OG000 |
| Group 2 | Placebo-Efgartigimod | Participants received efgartigimod 10 mg/kg via intravenous infusion once weekly or once every 2 weeks for up to 48 weeks in this study.~This reporting group presents the participants who received placebo in the parent study (ARGX-113-2106). | 4 | 7 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period
- Description
Blood samples were collected to assess anti-drug antibodies (ADAs) against efgartigimod. Samples were analyzed by the designated laboratory in a 3-tiered approach using validated immunogenicity assays. ADA incidence included total number of participants with treatment-boosted and treatment-induced ADA. Treatment-boosted ADA was defined as participants who had a baseline positive sample and the titer value increased 4-fold or more compared to baseline. Treatment-induced ADA was defined as participants who had a baseline negative sample and at least 1 positive post-baseline samples. Number of participants with ADA incidence is presented here.
- Time frame
- From Baseline (Day 1) up to 48 weeks
- Population
- The SAF included all FAS participants who had been administered at least 1 dose of study drug.
Source ClinicalTrials.gov
Trial
- Title
- Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome
- NCT number
- NCT06203457
- Phases
- PHASE2
- Conditions
- Primary Sjögren's Syndrome
- Interventions
- Efgartigimod
- Lead sponsor
- argenx
- Results first posted
- 2026-02-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06203457?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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