A Phase 3 interventional study of efgartigimod PH20 SC and prednisone in Pemphigus Vulgaris and Pemphigus Foliaceus, sponsored by argenx. Terminated at 127 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by argenx · Phase 3, Interventional, and Treatment
This was a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who participated in antecedent trial ARGX-113-1904. This trial provided extension of efgartigimod PH20 SC treatment and retreatment options for participants who had been randomized to efgartigimod PH20 SC treatment arm in the trial ARGX-113-1904, and first treatment of efgartigimod PH20 SC and retreatment options for participants who had been randomized to the placebo arm in trial ARGX-113-1904. The participants could also receive concomitant prednisone therapy. Investigators could increase or decrease the prednisone dose based on protocol-specified criteria.
Trial ARGX-113-1905 evaluated the ability to (further) taper prednisone therapy and achieve Clinical Remission (CR) off therapy (CRoff), the ability to achieve CR and CR on minimal therapy (CRmin) for participants who had not yet achieved CR or CRmin, and the ability to treat flare; it also assessed patient outcome measures and the safety, PD, PK and immunogenicity of efgartigimod PH20 SC over the duration of trial.
Study duration: Up to 60 weeks for participants who receive IMP administration up to 52 weeks and with a follow-up period of 8 weeks after the last IMP administration
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's enrollment of 183 is above the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →argenx is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 16 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
use by men and women should be consistent with local regulations regarding the methods for contraception for those participating in clinical trials and:
Male participants:
Male participants must agree to use an acceptable method of contraception as described in the protocol, from signing the ICF until the last dose of the study drug.
Women of (WOCBP) must:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients receiving efgartigimod PH20 SC on top of prednisone
Biological: efgartigimod PH20 SC · Drug: prednisone
Drug pages: Efgartigimod alfa · Hyaluronidase (human recombinant)
Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer
Oral prednisone tablets
Incidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE)
Incidence rates were calculated as 100 × n/PYFU. PYFU=participant-years of follow-up. The safety data sets includes participants with pemphigus vulgaris (PV) and pemphigus foliaceus (PF).
Time frame: Up to 60 weeks
Proportion of Participants With Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Who Achieve CRmin
CRmin defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
Time frame: Up to 60 weeks
Proportion of Participants With Pemphigus Vulgaris (PV) Who Achieve CRmin
CRmin (complete clinical remission on minimal prednisone therapy) defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
Time frame: Up to 60 weeks
Time to DC in Participants With PV and PF
Disease Control (DC) defined as absence of new lesions and the start of healing of established lesions
Time frame: Up to 52 weeks
Time to CR in Participants With PV and PF
CR (Complete clinical remission) defined as the absence of new lesions and complete healing of established lesions
Time frame: Up to 52 weeks
Time to CRmin in Participants With PV and PF
CRmin defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
Time frame: Up to 52 weeks
Time to CRoff in Participants With PV and PF
Complete remission off therapy (CRoff) is defined as the absence of new and established lesions completely healed while the patient is receiving no prednisone therapy for at least 8 weeks.
Time frame: Up to 52 weeks
Time to Flare After CRmin in Participants With PV and PF
CRmin defined as defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
Time frame: Up to 52 weeks
Rate of Treatment Failure in Participants With PV and PF
The absence of DC with oral prednisone 1.5 mg/kg/day for a minimum of 3 weeks, or absence of DC due to prednisone-related SAE, or flare before CRmin resulting in withdrawal of the participant.
Time frame: Up to 52 weeks
Number of Flares in Participants With PV and PF
A flare is defined as the appearance of 3 or more new lesions in a 4-week period that do not heal spontaneously within 1 week or the extension, of established lesions in a participant who had achieved DC.
Time frame: Up to 60 weeks
Normalized Cumulative Prednisone Dose in Participants With PV and PF
Normalized Cumulative prednisone dose (NCPD, mg/kg/day) is the average daily intake of all weight-adjusted prednisone doses received during the study, taking into account the number of days in study
Time frame: Up to 60 weeks
This study was terminated early based on the lack of observed efficacy in antecedent ARGX-113-1904. A total of 183 participants rolled over from ARGX-113-1904. Of these, 57 participants had a CRmin status (complete remission on minimal prednisone therapy) at rollover of which 34 participants did not receive efgartigimod PH20 SC in this ARGX-113-1905 study.
| Milestone | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Started | 123 | 60 |
| Completed | 64 | 23 |
| Not completed | 59 | 37 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 7 | 2 |
| Withdrew: Pregnancy | 0 | 1 |
| Withdrew: Requires prohibited medication | 0 | 1 |
| Withdrew: Study terminated by sponsor | 18 | 12 |
| Withdrew: Withdrawal by subject | 16 | 12 |
| Withdrew: Other | 15 | 8 |
Incidence rates were calculated as 100 × n/PYFU. PYFU=participant-years of follow-up. The safety data sets includes participants with pemphigus vulgaris (PV) and pemphigus foliaceus (PF).
| number of events x 100/PYFU | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Treatment-Emergent Adverse Event (TEAE) | 116.4 | 113.0 |
| Adverse Event of Special Interest (AESI) | 72.0 | 69.3 |
| Serious Adverse Event (SAE) | 24.5 | 14.6 |
CRmin defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
| Participants | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Proportion of Participants With Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Who Achieve CRmin | 55 | 26 |
CRmin (complete clinical remission on minimal prednisone therapy) defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
| Participants | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Proportion of Participants With Pemphigus Vulgaris (PV) Who Achieve CRmin | 47 | 22 |
Disease Control (DC) defined as absence of new lesions and the start of healing of established lesions
| days | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Time to DC in Participants With PV and PF | 8.5 (8.0 to 15.0) | 15.0 (8.0 to 22.0) |
CR (Complete clinical remission) defined as the absence of new lesions and complete healing of established lesions
| Days | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Time to CR in Participants With PV and PF | 66.0 (43.0 to 182.0) | 71.0 (41.0 to 100.0) |
CRmin defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
| days | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Time to CRmin in Participants With PV and PF | 229.0 (161.0 to NA) | 169.0 (141.0 to 322.0) |
Complete remission off therapy (CRoff) is defined as the absence of new and established lesions completely healed while the patient is receiving no prednisone therapy for at least 8 weeks.
| days | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Time to CRoff in Participants With PV and PF | NA (NA to NA) | NA (NA to NA) |
CRmin defined as defined as the absence of new lesions and complete healing of established lesions while the participant was receiving prednisone at ≤10 mg/day for at least 8 weeks.
| days | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Time to Flare After CRmin in Participants With PV and PF | 339.0 (223.0 to NA) | 168.0 (64.0 to NA) |
The absence of DC with oral prednisone 1.5 mg/kg/day for a minimum of 3 weeks, or absence of DC due to prednisone-related SAE, or flare before CRmin resulting in withdrawal of the participant.
| Participants | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Rate of Treatment Failure in Participants With PV and PF | 3 | 1 |
A flare is defined as the appearance of 3 or more new lesions in a 4-week period that do not heal spontaneously within 1 week or the extension, of established lesions in a participant who had achieved DC.
| Flares | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Number of Flares in Participants With PV and PF | 0.8 ± 1.03 | 0.7 ± 0.79 |
Normalized Cumulative prednisone dose (NCPD, mg/kg/day) is the average daily intake of all weight-adjusted prednisone doses received during the study, taking into account the number of days in study
| mg/kg/day | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| Normalized Cumulative Prednisone Dose in Participants With PV and PF | 0.212 ± 0.2018 | 0.241 ± 0.2401 |
Collected over Up to 60 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Efgartigimod-efgartigimod PH20 SC | 0/101 (0%) | 16/101 (15.8%) | 46/101 (45.5%) |
| Placebo-efgartigimod PH20 SC | 1/48 (2.1%) | 4/48 (8.3%) | 19/48 (39.6%) |
| Event | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| PEMPHIGUSSkin and subcutaneous tissue disorders | 3/101 | 1/48 |
| LUNG ABSCESSInfections and infestations | 0/101 | 1/48 |
| SEPSISInfections and infestations | 0/101 | 1/48 |
| SKIN INFECTIONInfections and infestations | 0/101 | 1/48 |
| PATELLA FRACTUREInjury, poisoning and procedural complications | 0/101 | 1/48 |
| MUSCULOSKELETAL PAINMusculoskeletal and connective tissue disorders | 0/101 | 1/48 |
| SHOCK HAEMORRHAGICVascular disorders | 0/101 | 1/48 |
| GASTRITIS EROSIVEGastrointestinal disorders | 2/101 | 0/48 |
| DISEASE PROGRESSIONGeneral disorders | 2/101 | 0/48 |
| COVID-19Infections and infestations | 2/101 | 0/48 |
| Event | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC |
|---|---|---|
| COVID-19Infections and infestations | 12/101 | 5/48 |
| HEADACHENervous system disorders | 3/101 | 4/48 |
| BLOOD LACTATE DEHYDROGENASE INCREASEDInvestigations | 7/101 | 1/48 |
| INCREASED TENDENCY TO BRUISEBlood and lymphatic system disorders | 0/101 | 3/48 |
| TACHYCARDIACardiac disorders | 1/101 | 3/48 |
| INJECTION SITE ERYTHEMAGeneral disorders | 4/101 | 3/48 |
| MYOPATHYMusculoskeletal and connective tissue disorders | 2/101 | 3/48 |
| HAEMATURIARenal and urinary disorders | 2/101 | 3/48 |
| PRURITUSSkin and subcutaneous tissue disorders | 2/101 | 3/48 |
| ORAL CANDIDIASISInfections and infestations | 6/101 | 0/48 |
Roll-over set
| Age, Continuous(years) | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC | Total |
|---|---|---|---|
| Mean | 50.1 ± 11.40 | 52.4 ± 13.02 | 50.8 ± 11.97 |
| Sex: Female, Male(Participants) | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC | Total |
|---|---|---|---|
| Female | 61 | 32 | 93 |
| Male | 62 | 28 | 90 |
| Race/Ethnicity, Customized(Participants) | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC | Total |
|---|---|---|---|
| Asian | 40 | 9 | 49 |
| Black or African American | 1 | 2 | 3 |
| White | 81 | 47 | 128 |
| Other | 1 | 2 | 3 |
| Race/Ethnicity, Customized(Participants) | Efgartigimod-efgartigimod PH20 SC | Placebo-efgartigimod PH20 SC | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 7 |
| Not Hispanic or Latino | 120 | 56 | 176 |
Showing the first 100 of 127 sites across 21 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2021 to primary completion in Mar 2024, 32 months.
Results were first posted in Mar 2025, 1 year after primary completion.
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This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Efgartigimod alfa · Hyaluronidase (human recombinant)