Trial · NCT05267600
A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
NCT05267600, Phase 2, Phase 3, Completed, argenx; results first posted 2025-10-23
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid. Trials, record NCT05267600. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05267600
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
- NCT number
- NCT05267600
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- argenx
- Conditions
- Bullous Pemphigoid
- Interventions
- efgartigimod PH20 SC, placebo, Prednisone
- First posted
- 2022-03-04
- Last updated
- 2025-10-23
- Results first posted
- 2025-10-23
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With CRoff at Week 36 | at week 36 | CRoff = complete remission while receiving efgartigimod PH20 SC or placebo 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 | Cumulative OCS Dose | up to week 36 | OCS = oral corticosteroid |
| Secondary | Number of Participants Who Achieve an IGA-BP Score of 0 While Off OCS Therapy for ≥8 Weeks at Week 36 | at week 36 | IGA-BP = Investigator Global Assessment of Bullous Pemphigoid. IGA-BP scores range from 0-4, with a higher score representing severe BP. OCS = oral corticosteroid |
| Secondary | Number of Participants With CDA Who Remained Free of Relapse Through Week 36 | up to week 36 | Control of disease activity (CDA) is defined as the point at which new lesions ceased to form, established lesions began to heal, and pruritic symptoms started to abate. 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. |
| Secondary | Number of Participants With CRmin at Week 36 | at week 36 | CRmin = complete remission receiving minimal oral corticosteroids for at least 8 weeks. Minimal oral corticosteroid (OCS) therapy is defined as ≤0.1 mg/kg/day of prednisone (or equivalent). |
| Secondary | Change From Baseline to Week 36 in the 24-Hour Average Itch NRS Score | up to week 36 | Itch NRS = Itch Numerical Rating Scale. The Itch NRS scores range from 0-10 with 10 representing the worst imaginable itch. |
| Secondary | Changes From Baseline in the BPDAI Total Activity Score | up to week 36 | BPDAI = Bullous Pemphigoid Disease Area Index (BPDAI) Total Activity Score is a tool to objectively measure disease activity. BPDAI scores range from 0 to 360 with a higher score indicating more severe disease (max 240 for total skin activity and 120 for mucosal activity). |
| Secondary | Time to CDA | up to week 36 | CDA = control of disease activity, the point at which new lesions ceased to form, established lesions began to heal, and pruritic symptoms started to abate. |
| Secondary | Time to CR | up to week 36 | CR = complete remission, the absence of new lesions, complete healing of existing lesions, and absence of pruritus. |
| Secondary | Time to CRmin | up to week 36 | CRmin = complete remission, the absence of new lesions, complete healing of existing lesions, and absence of pruritus while being on minimal dose of OCS for ≥8 Weeks. OCS = oral corticosteroid. Minimal OCS therapy is defined as an oral prednisone dosage of ≤0.10 mg/kg/day (or equivalent). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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 CRoff at Week 36 | at week 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cumulative OCS Dose | up to week 36 | mg/kg/day | MEAN | |
| SECONDARY | Number of Participants Who Achieve an IGA-BP Score of 0 While Off OCS Therapy for ≥8 Weeks at Week 36 | at week 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With CDA Who Remained Free of Relapse Through Week 36 | up to week 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With CRmin at Week 36 | at week 36 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline to Week 36 in the 24-Hour Average Itch NRS Score | up to week 36 | Only participants with an assessment at baseline and at week 36 are reported. | score on a scale | MEAN |
| SECONDARY | Changes From Baseline in the BPDAI Total Activity Score | up to week 36 | Only participants with an assessment at baseline and week 36 are reported here. | score on a scale | MEAN |
| SECONDARY | Time to CDA | up to week 36 | days | MEDIAN | |
| SECONDARY | Time to CR | up to week 36 | days | MEDIAN | |
| SECONDARY | Time to CRmin | up to week 36 | days | MEDIAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group65
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 CRoff at Week 36 | Efgartigimod PH20 SC | 8 | Participants | ||
| Number of Participants With CRoff at Week 36 | Placebo PH20 SC | 2 | Participants | ||
| Cumulative OCS Dose | Efgartigimod PH20 SC | 0.242 | Standard Deviation 0.138 | mg/kg/day | |
| Cumulative OCS Dose | Placebo PH20 SC | 0.289 | Standard Deviation 0.173 | mg/kg/day | |
| Number of Participants Who Achieve an IGA-BP Score of 0 While Off OCS Therapy for ≥8 Weeks at Week 36 | Efgartigimod PH20 SC | 9 | Participants | ||
| Number of Participants Who Achieve an IGA-BP Score of 0 While Off OCS Therapy for ≥8 Weeks at Week 36 | Placebo PH20 SC | 3 | Participants | ||
| Number of Participants With CDA Who Remained Free of Relapse Through Week 36 | Efgartigimod PH20 SC | 7 | Participants | ||
| Number of Participants With CDA Who Remained Free of Relapse Through Week 36 | Placebo PH20 SC | 8 | Participants | ||
| Number of Participants With CRmin at Week 36 | Efgartigimod PH20 SC | 8 | Participants | ||
| Number of Participants With CRmin at Week 36 | Placebo PH20 SC | 3 | Participants |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Efgartigimod PH20 SC | 50 | |
| Overall Study | STARTED | Placebo PH20 SC | 48 | |
| Overall Study | COMPLETED | Efgartigimod PH20 SC | 35 | |
| Overall Study | COMPLETED | Placebo PH20 SC | 35 | |
| Overall Study | NOT COMPLETED | Efgartigimod PH20 SC | 15 | |
| Overall Study | NOT COMPLETED | Placebo PH20 SC | 13 |
Source ClinicalTrials.gov
Adverse events168
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 | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Efgartigimod PH20 SC | 5 | 50 | |
| other | INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | Placebo PH20 SC | 7 | 48 | |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | Efgartigimod PH20 SC | 0 | 50 | |
| other | LEUKOCYTOSIS | Blood and lymphatic system disorders | Placebo PH20 SC | 4 | 48 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Efgartigimod PH20 SC | 5 | 50 | |
| other | LYMPHOPENIA | Blood and lymphatic system disorders | Placebo PH20 SC | 3 | 48 | |
| other | CUSHINGOID | Endocrine disorders | Efgartigimod PH20 SC | 4 | 50 | |
| other | CUSHINGOID | Endocrine disorders | Placebo PH20 SC | 0 | 48 | |
| other | CONSTIPATION | Gastrointestinal disorders | Efgartigimod PH20 SC | 3 | 50 | |
| other | CONSTIPATION | Gastrointestinal disorders | Placebo PH20 SC | 0 | 48 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Efgartigimod PH20 SC | 1 | 50 |
| Total, all-cause mortality | Placebo PH20 SC | 2 | 48 |
| Total, other adverse events | Efgartigimod PH20 SC | 47 | 50 |
| Total, other adverse events | Placebo PH20 SC | 46 | 48 |
| Total, serious adverse events | Efgartigimod PH20 SC | 12 | 50 |
| Total, serious adverse events | Placebo PH20 SC | 12 | 48 |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Efgartigimod PH20 SC vs Placebo PH20 SC: Number of Participants Who Achieve an IGA-BP Score of 0 While Off OCS Therapy for ≥8 Weeks at Week 36 | Trial comparisons |
| Efgartigimod PH20 SC vs Placebo PH20 SC: Number of Participants With CDA Who Remained Free of Relapse Through Week 36 | Trial comparisons |
| Efgartigimod PH20 SC vs Placebo PH20 SC: Number of Participants With CRoff at Week 36 | Trial comparisons |
| Efgartigimod PH20 SC vs Placebo PH20 SC: Number of Participants With CRmin at Week 36 | Trial comparisons |
| Efgartigimod PH20 SC vs Placebo PH20 SC: Number of Participants Who Receive Rescue Therapy Before Week 36 | Trial comparisons |
| Efgartigimod PH20 SC vs Placebo PH20 SC: deaths from any cause | Trial comparisons |
| Efgartigimod PH20 SC vs Placebo PH20 SC: serious adverse events | Trial comparisons |
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/NCT05267600
GET https://conductscience.org/api/trials/v1/NCT05267600/registered?page=2