Trial · NCT05681481
A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
NCT05681481, Phase 3, Terminated, argenx; results first posted 2026-02-25
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid. Trials, record NCT05681481. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05681481
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
- NCT number
- NCT05681481
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 64 participants, actual
- Lead sponsor
- argenx
- Conditions
- Bullous Pemphigoid
- Interventions
- efgartigimod PH20 SC, Prednisone
- First posted
- 2023-01-12
- Last updated
- 2026-02-25
- Results first posted
- 2026-02-25
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent AEs, SAEs and AESIs | Efgartigimod PH20 SC | AE | 40 | Participants | |
| Number of Participants With Treatment-emergent AEs, SAEs and AESIs | Efgartigimod PH20 SC | SAE | 13 | Participants | |
| Number of Participants With Treatment-emergent AEs, SAEs and AESIs | Efgartigimod PH20 SC | AESI | 25 | Participants | |
| Number of Participants Who Discontinued Treatment Because of Safety Concerns | Efgartigimod PH20 SC | 4 | Participants | ||
| Number of Participants Achieving CRoff for ≥ 8 Weeks | Efgartigimod PH20 SC | 3 | Participants | ||
| Number of Participants Achieving CRoff or PRoff for ≥ 8 Weeks | Efgartigimod PH20 SC | 3 | Participants | ||
| Number of Participants Achieving CRmin for ≥ 8 Weeks | Efgartigimod PH20 SC | 4 | Participants | ||
| Number of Participants Achieving Complete Remission While Off Both Oral Corticosteroids and Efgartigimod PH20 SC for ≥ 8 Weeks | Efgartigimod PH20 SC | 10 | Participants | ||
| Number of Participants Achieving CR or PR While Off Both OCS and Efgartigimod PH20 SC for ≥ 8 Weeks | Efgartigimod PH20 SC | 10 | Participants | ||
| Duration of Sustained Remission | Efgartigimod PH20 SC | NA | 95% Confidence Interval 54.0 to ? | days |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Efgartigimod PH20 SC | 64 | |
| Overall Study | COMPLETED | Efgartigimod PH20 SC | 17 | |
| Overall Study | NOT COMPLETED | Efgartigimod PH20 SC | 47 |
Source ClinicalTrials.gov
Adverse events29
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Efgartigimod PH20 SC | 3 | 50 | |
| other | Nausea | Gastrointestinal disorders | Efgartigimod PH20 SC | 3 | 50 | |
| other | Injection site paraesthesia | General disorders | Efgartigimod PH20 SC | 4 | 50 | |
| other | Oedema peripheral | General disorders | Efgartigimod PH20 SC | 4 | 50 | |
| other | Nasopharyngitis | Infections and infestations | Efgartigimod PH20 SC | 4 | 50 | |
| other | Urinary tract infection | Infections and infestations | Efgartigimod PH20 SC | 4 | 50 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Efgartigimod PH20 SC | 5 | 50 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Efgartigimod PH20 SC | 5 | 50 | |
| other | Insomnia | Psychiatric disorders | Efgartigimod PH20 SC | 3 | 50 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Efgartigimod PH20 SC | 3 | 50 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efgartigimod PH20 SC | 1 | 50 |
| Total, other adverse events | Efgartigimod PH20 SC | 38 | 50 |
| Total, serious adverse events | Efgartigimod PH20 SC | 13 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05681481
GET https://conductscience.org/api/trials/v1/NCT05681481/events?page=2