Trial · NCT06203457
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With TEAEs, TESAEs and TEAESIs | From the first dose of study drug (Day 1) up to 60 days post last study drug, approximately 56 weeks | The safety analysis set (SAF) included all FAS participants who had been administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of CRESS Responders at Weeks 24 and 48 | Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSDAI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Low Disease Activity in ESSDAI at Weeks 24 and 48 | Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Minimal Clinically Important Improvement From Baseline in clinESSDAI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Low Disease Activity in clinESSDAI at Weeks 24 and 48 | Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Minimal Clinically Important Improvement From Baseline in ESSPRI at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in ESSDAI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in clinESSDAI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | score on a scale | MEDIAN |
| SECONDARY | Change From Baseline in ESSPRI Score at Weeks 24 and 48 | Baseline (Day 1) and Weeks 24 and 48 | The FAS included all enrolled participants. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | score on a scale | MEDIAN |
| SECONDARY | Number of STAR Responders at Weeks 24 and 48 | Weeks 24 and 48 | The FAS included all enrolled participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Total IgG Levels in Serum at Week 48 | Baseline (Day 1) and Week 48 | The FAS included all enrolled participants. Only those participants with data collected at Baseline and Week 48 are reported. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Autoantibodies in Serum at Week 48 | Baseline (Day 1) and Week 48 | The FAS included all enrolled participants. Only those participants with data collected at Baseline and Week 48 are reported. | percent change | MEAN |
| SECONDARY | Serum Concentrations of Efgartigimod | Pre-dose and post-dose at Baseline (Day 1) and pre-dose at Weeks 24 and 48 | The PK analysis set included all enrolled participants who received at least 1 dose of efgartigimod and had at least 1 measured concentration of efgartigimod at a scheduled PK time point after start of dosing without protocol violations or events with potential to affect the PK concentration. Only those participants with data collected at Baseline, Weeks 24 and 48 are reported. | microgram/milliliter (mcg/mL) | MEAN |
| SECONDARY | Number of Participants With ADA Against Efgartigimod Over the 48-week Treatment Period | From Baseline (Day 1) up to 48 weeks | The SAF included all FAS participants who had been administered at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT06203457/outcomes