Trial · NCT05681481
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent AEs, SAEs and AESIs | Up to 56 weeks | Safety analysis set: all participants who rolled over from ARGX-113-2009, provided informed consent for ARGX-113-2010, and received at least 1 dose of efgartigimod PH20 SC in ARGX-113-2010. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Discontinued Treatment Because of Safety Concerns | Up to 56 weeks | Safety analysis set: all participants who rolled over from ARGX-113-2009, provided informed consent for ARGX-113-2010, and received at least 1 dose of efgartigimod PH20 SC in ARGX-113-2010. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving CRoff for ≥ 8 Weeks | Up to 56 weeks | Only participants evaluable for CRoff for \>=8 weeks are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving CRoff or PRoff for ≥ 8 Weeks | Up to 56 weeks | Only participants evaluable for CRoff or PRoff for \>=8 weeks are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving CRmin for ≥ 8 Weeks | Up to 56 weeks | Only participants evaluable for CRmin for \>=8 weeks are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Complete Remission While Off Both Oral Corticosteroids and Efgartigimod PH20 SC for ≥ 8 Weeks | Up to 56 weeks | Only participants evaluable for CR while off both OCS therapy and Efgartigimod PH20 SC for \>=8 weeks are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving CR or PR While Off Both OCS and Efgartigimod PH20 SC for ≥ 8 Weeks | Up to 56 weeks | Only participants evaluable for CR or PR while off both OCS therapy and Efgartigimod PH20 SC for \>=8 weeks are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Sustained Remission | Up to 56 weeks | Only participants evaluable for duration of sustained remission are reported here. | days | MEDIAN |
| SECONDARY | Number of Participants Who Relapsed | Up to 56 weeks | Rollover set: all participants who rolled over from ARGX-113-2009 and provided informed consent for ARGX-113-2010.~Only participants evaluable for relapse from CDA, CR or PR onset are reported here. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Relapse | Up to 56 weeks | Only participants evaluable for time to relapse from CDA, CR or PR onset are reported here. | days | MEDIAN |
| SECONDARY | BPDAI Activity Score, Percent Change From Baseline to Last Assessment | Up to 56 weeks | Only participants with an assessment at baseline and at least one post-baseline assessment are reported here. | Percent change | MEAN |
| SECONDARY | IGA-BP Score at Last Assessment | Up to 56 weeks | Only participants with an assessment at baseline and at least one post-baseline assessment are reported here. | Participants | NUMBER |
| SECONDARY | Itch NRS 24-hour Average Score, Change From Baseline to Last Assessment | Up to 56 weeks | Only participants with an assessment at baseline and at least one post-baseline assessment are reported here. | score on a scale | MEAN |
| SECONDARY | Number of Participants Who Failed Treatment | Up to 56 weeks | Only participants evaluable for treatment failure are reported here. | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05681481/outcomes