Comparison · NCT04598451-107e79b7
Efgartigimod PH20 SC vs Placebo PH20 SC: Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Efgartigimod PH20 SC vs Placebo PH20 SC: Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy. Trial comparisons, record NCT04598451-107e79b7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04598451-107e79b7
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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 | 0.355 | 0.276 | 0.442 | wilson | |
| Risk in group 2 | 0.303 | 0.206 | 0.422 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0518 | -0.091 | 0.183 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.757 | 1.81 | log | |
| Odds ratio, group 1 over group 2 | 1.27 | 0.666 | 2.4 | log | |
| Number needed to treat, for one more participant with the outcome on Efgartigimod PH20 SC than on Placebo PH20 SC | 19.3 | 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 PH20 SC | Patients randomized to receive weekly administrations of efgartigimod PH20 until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol | 44 | 124 | OG000 |
| Group 2 | Placebo PH20 SC | Patients randomized to receive weekly administrations of placebo PH20 SC until CRmin (complete remission on minimal prednisone therapy) or end of treatment period or early roll-over to the open-label extension study ARGX-113-1905. All participants received concurrent oral prednisone (or equivalent) at a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted according to recommendations as per protocol | 20 | 66 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy
- Description
Proportion of participants with pemphigus vulgaris who had CRmin within 30 weeks, defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
- Time frame
- up to 30 weeks treatment period
- Population
Randomized participants with pemphigus vulgaris (PV) who received at least part of a dose of efgartigimod PH20 SC or placebo PH20 SC. These participants also received prednisone with a starting dosage of 0.5 mg/kg/day. The dose of prednisone was adjusted per protocol
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
- NCT number
- NCT04598451
- Phases
- PHASE3
- Conditions
- Pemphigus Vulgaris, Pemphigus Foliaceus
- Interventions
- efgartigimod PH20 SC, Placebo, prednisone
- Lead sponsor
- argenx
- Results first posted
- 2024-10-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04598451?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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