Trial · NCT05681481
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent AEs, SAEs and AESIs | Up to 56 weeks | Adverse events, Serious Adverse event and Adverse events of special interest. Adverse events in the 'Infections and infestations' SOC were defined as AESIs because efgartigimod causes a transient reduction in total IgG levels. |
| Primary | Number of Participants Who Discontinued Treatment Because of Safety Concerns | Up to 56 weeks | |
| Secondary | Number of Participants Achieving CRoff for ≥ 8 Weeks | Up to 56 weeks | CRoff = complete remission while receiving efgartigimod PH20 SC and being off oral corticosteroid therapy for at least 8 weeks. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. |
| Secondary | Number of Participants Achieving CRoff or PRoff for ≥ 8 Weeks | Up to 56 weeks | CRoff / PRoff = complete or partial remission while receiving efgartigimod PH20 SC and being off oral corticosteroid therapy for at least 8 weeks. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. Partial remission is defined as the presence of only new transient lesions. |
| Secondary | Number of Participants Achieving CRmin for ≥ 8 Weeks | Up to 56 weeks | Minimal oCRmin = complete remission while being on minimal dose of OCS for ≥ 8 weeks. OCS = oral corticosteroid. Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus Minimal OCS therapy is defined as ≤0.10 mg/kg/day of prednisone (or an equivalent dose of another oral corticosteroid) |
| Secondary | Number of Participants Achieving Complete Remission While Off Both Oral Corticosteroids and Efgartigimod PH20 SC for ≥ 8 Weeks | Up to 56 weeks | CR = complete remission; OCS = oral corticosteroids; Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus |
| Secondary | Number of Participants Achieving CR or PR While Off Both OCS and Efgartigimod PH20 SC for ≥ 8 Weeks | Up to 56 weeks | CR = complete remission; PR = partial remission; OCS = oral corticosteroids Complete remission is defined as the absence of new lesions, complete healing of existing lesions and absence of pruritus. Partial remission is defined as the presence of only new transient lesions. |
| Secondary | Duration of Sustained Remission | Up to 56 weeks | Sustained remission is defined as healing of lesions with no nontransient lesions (ie, BPDAI activity score of 0) and absence of pruritus while the participant was off concurrent BP therapy (and, for participants enrolled prior to protocol amendment 2, efgartigimod PH20 SC) for ≥8 weeks. New lesions that heal within 1 week or pruritus lasting \<1 week and clearing without treatment were not considered to change the condition of sustained remission. |
| Secondary | Number of Participants Who Relapsed | Up to 56 weeks | Relapse is defined as the appearance of 3 or more new lesions a month or at least 1 large lesion that did not heal within 1 week, or extension of established lesions or daily pruritus in a participant who had achieved CDA (Control of disease activity): the point at which new lesions cease to form and established lesions begin to heal, and pruritic symptoms start to abate |
| Secondary | Time to Relapse | Up to 56 weeks | Relapse is defined as the appearance of 3 or more new lesions a month or at least 1 large lesion that did not heal within 1 week, or extension of established lesions or daily pruritus in a participant who had achieved CDA (Control of disease activity): the point at which new lesions cease to form and established lesions begin to heal, and pruritic symptoms start to abate |
| Secondary | BPDAI Activity Score, Percent Change From Baseline to Last Assessment | Up to 56 weeks | The Bullous Pemphigoid Disease Area Index (BPDAI) is an internationally validated tool to objectively measure disease activity. The BPDAI differentiates scores for skin (erosions/blisters and urticaria/erythema) and mucous membrane activity in several anatomical locations. BPDAI activity scores range from 0 to 360, with a higher score representing more severe disease. |
| Secondary | IGA-BP Score at Last Assessment | Up to 56 weeks | The Investigator Global Assessment of Bullous Pemphigoid (IGA-BP) is a tool used to asses BP disease activity and severity. The IGA-BP categorizes the severity of BP on a numerical scale of 0 (clear) to 4 (severe). |
| Secondary | Itch NRS 24-hour Average Score, Change From Baseline to Last Assessment | Up to 56 weeks | The Itch Numerical Rating Scale (NRS) is used to indicate pruritic symptoms of BP. The score varies between 0 (best outcome) to 10 (worst outcome) |
| Secondary | Number of Participants Who Failed Treatment | Up to 56 weeks | Treatment failure is defined as the absence of CDA despite receiving efgartigimod PH20 SC with escalated dosages of prednisone (or equivalent OCS) |
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/registered