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Pemphigus VulgarisPhase 3ADDRESSNCT04598451

A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

A Phase 3 study testing efgartigimod PH20 SC and prednisone in people with Pemphigus Vulgaris and Pemphigus Foliaceus, run by argenx at 134 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult participants aged from 18 years with PV or PF. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pemphigus Vulgaris, Pemphigus Foliaceus
What is being tested?
efgartigimod PH20 SC and prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
222 participants
Where
134 sitesin 21 countries
Study dates
1 Dec 2020to 22 Aug 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), willingness and ability to comply with the trial protocol procedures (including required trial visits).
  • The participant is male or female, and aged from 18 years at the time of signing the informed consent form (ICF).
  • The participant has a clinical diagnosis of PV (mucosal, cutaneous, mucocutaneous) or PF which has been confirmed by cutaneous histology, positive direct immunofluorescence (IF), and positive indirect IF and/or enzyme-linked immunosorbent assay (ELISA).
  • The participant meets one of the following profiles:
  • Newly diagnosed disease with PDAI ≥15 at baseline and naïve to treatment
  • Newly diagnosed disease with PDAI ≥15 while receiving a first course of oral prednisone (or equivalent). According to clinical judgment, the participant has shown no significant improvement of PV or PF signs for at least 2 weeks before baseline and is considered fit to start prednisone treatment at 0.5 mg/kg qd at baseline.
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  • Experiencing flare with PDAI ≥15, a maximum of 4 years since diagnosis, and off prednisone therapy ± a conventional immunosuppressant (e.g., azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil) or dapsone. Note: conventional immunosuppressants and dapsone must be discontinued before baseline.
  • Experiencing flare with PDAI ≥15, a maximum of 4 years since diagnosis, and receiving a tapered dose of oral prednisone (or the equivalent), provided that prednisone has been given at stable dose ± a conventional immunosuppressant for at least 2 weeks and patients are fit to start prednisone treatment at 0.5 mg/kg qd at baseline.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating clinical trials and:
  • Male participants: Male participants must agree to use acceptable method of contraception, and not donate sperm from signing the ICF until the end of the study.
  • Female participants: Women of childbearing potential must:
  • have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline before the IMP can be administered.
  • agree to use a highly effective or acceptable contraception method, which should be maintained at minimum until after the last dose of IMP
  • For Japanese participants enrolled in sites in Japan only: A Japanese participant is defined as a participant whose parents and 4 grandparents are Japanese, and who has Japanese nationality, was born in Japan, has not lived outside of Japan for a total of >10 years, and currently lives in Japan.

Who cannot join

  • Participant has a confirmed diagnosis of paraneoplastic pemphigus, drug-induced pemphigus, pemphigus vegetans, pemphigus erythematosus, or any other non-PV/non-PF autoimmune blistering disease.
  • Participants with mild disease severity as defined by PDAI <15 at baseline.
  • Participants who show a significant improvement of PV or PF in the period from screening to baseline according to clinical judgment (eg, the patient has achieved DC or a substantial reduction in PDAI activity score during screening period).
  • The participant has been administered therapy(ies) other than oral prednisone or conventional immunosuppressants (e.g., azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil) or dapsone within 2 months before the baseline visit and that can affect clinical disease activity. For example, excluded medications are intravenous methylprednisolone, dapsone, sulfasalazine, tetracyclines, nicotinamide at doses above the recommended daily allowance (RDA)/dietary reference intake (DRI), plasmapheresis/ plasma exchange, immunoadsorption, and IVIg.
  • Use of any monoclonal antibody (including rituximab or another anti-CD20 biologic) within 6 months before the baseline visit.
  • Known hypersensitivity to any of the components of the administered treatments.
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  • The participant has a known contraindication to oral prednisone.
  • The participant has a history of refractory disease, as defined by a failure to respond to first-line and second-line therapies
  • Participants who have a history of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before first IMP administration. Participants with any of the following cancers can be included at any time, provided they are adequately treated prior to their participation in the study:
  • Basal cell or squamous cell skin cancer,
  • Carcinoma in situ of the cervix,
  • Carcinoma in situ of the breast,
  • Incidental histological finding of prostate cancer
  • Participants with clinical evidence of other significant serious disease or participants who recently underwent or have planned a major surgery during the period of the trial, or any other condition in the opinion of the investigator, that could confound the results of the trial or put the patient at undue risk.
  • Pregnant and lactating women and those intending to become pregnant during the trial.
  • Current or history (i.e. within 12 months of screening) of alcohol, drug, or medication abuse.
  • Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of PV or PF or put the participant at undue risk.
  • The participant has a Karnofsky Performance score <60%.
  • Vaccination with live viral vaccines within 28 days prior to randomization.
  • The participant has clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
  • Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B Virus, Hepatitis C Virus , HIV.
  • The participant has total immunoglobulin G (IgG) <6 g/L at screening.
  • The participant has previously participated in a trial with efgartigimod and has received at least one administration of IMP.
  • Use of an investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to first IMP administration

Trial locations and contacts

134 sites in 21 countries.

134 sites in 21 countries

United States21 sites

  • Investigator site 77 - US0010086

    Birmingham, Alabama, 35233

  • Investigator site 2 - US0010087

    Boca Raton, Florida, 33428

  • Investigator site 19 - US0010088

    Buffalo, New York, 14203-1070

  • Investigator site 125 - US0010153

    Castle Rock, Colorado, 80109

  • Investigator site 20 - US0010094

    Cleveland, Ohio, 44106-1716

  • Investigator site 98 - US0010107

    Dallas, Texas, 75246

  • Investigator site 1 - US0010084

    Dripping Springs, Texas, 78620

  • Investigator site 60 - US0010096

    Durham, North Carolina, 27710

  • Investigator site 126 - US0010182

    Houston, Texas, 77004

  • Investigator site 88 - US0010114

    Houston, Texas, 77008

  • Investigator site 99 - US0010117

    Miami, Florida, 33173

  • Investigator site 61 - US0010090

    Minneapolis, Minnesota, 55455

  • Investigator site 136 - US0010196

    New York, New York, 10128

  • Investigator site 59 - US0010106

    Norfolk, Virginia, 23502

  • Investigator site 78 - US0010109

    Orlando, Florida, 32827

  • Investigator site 73 - US00100

    Philadelphia, Pennsylvania, 19104

  • Investigator site 101 - US0010097

    Philadelphia, Pennsylvania, 19140

  • Investigator site 121 - US0010092

    Redwood City, California, 94063

  • Investigator site 97 - US0010091

    Scottsdale, Arizona, 85259

  • Investigator site 102 - US0010098

    St Louis, Missouri, 63110

  • Investigator site 127 - US0010155

    West Lafayette, Indiana, 47906

Other trials in United States

China13 sites

  • Investigator site 110 - CN0860017

    Beijing, 100034

  • Investigator site 111 - CN0860018

    Chendu, 610000

  • Investigator site 131 - CH0860027

    Chongqing, 400042

  • Investigator site 118 - CN0860023

    Fujian, 350005

  • Investigator site 120 - CN0860022

    Guangzhou, 510000

  • Investigator site 128 - CH0860053

    Guangzhou, 51000

  • Investigator site 109 - CN0860021

    Guanzhou, 510000

  • Investigator site 119 - CN0860024

    Nanjing

  • Investigator site 112 - CN0860020

    Shanghai, 200025

  • Investigator site 108 - CN0860016

    Shanghai, 200040

  • Investigator site 113 - CN0860025

    Wuhan, 430022

  • Investigator site 123 - CN0860019

    Wuhan, 430022

  • Investigator site 129 - CH0860026

    Zhengzhou, 450008

Other trials in China

Germany10 sites

  • Investigator site 64 - DE0490029

    Berlin, 10117

  • Investigator site 48 - DE0490030

    Dresden, 01307

  • Investigator site 49 - DE0490024

    Frankfurt am Main, 60590

  • Investigator site 47 - DE0490023

    Freiburg im Breisgau, 79104

  • Investigator site 38 - DE0490028

    Kiel, 24105

  • Investigator site 37 - DE0490002

    Lübeck, 23538

  • Investigator site 68 - DE0490001

    Marburg, 35043

  • Investigator site 25 - DE0490025

    Tübingen, 72076

  • Investigator site 79 - DE0490027

    Ulm, 89081

  • Investigator site 21 - DE0490026

    Würzburg, 97080

Other trials in Germany

Japan10 sites

  • Investigator site 94 - JP0810046

    Aichi, 480-1195

  • Investigator site 81 - JP0810040

    Hiroshima, 734-8551

  • Investigator site 82 - JP0810042

    Kofu, 400-8506

  • Investigator site 85 - JP0810050

    Kurume, 830-001

  • Investigator site 84 - JP0810047

    Okayama, 700-8558

  • Investigator site 93 - JP0810041

    Okayama, 701-0192

  • Investigator site 86 - JP0810049

    Osaka, 545-8586

  • Investigator site 74 - JP0810045

    Sapporo, 060-8648

  • Investigator site 124 - JP0810067

    Sendai, 980-8574

  • Investigator site 83 - JP0810043

    Tokyo, 113-8431

Other trials in Japan

Spain10 sites

  • Investigator site 29 - ES0340026

    Barcelona, 08907

  • Investigator site 15 - ES0340032

    Barcelona, 8036

  • Investigator site 130 - ES0340053

    Granada, 18016

  • Investigator site 67 - ES0340034

    Madrid, 28007

  • Investigator site 10 - ES0340025

    Madrid, 28034

  • Invetistigator site 8 - ES0340029

    Madrid, 28041

  • Investigator site 6 - ES0340027

    Madrid, 28046

  • Investigator site 134 - ES0340057

    Málaga, 28009

  • Investigator site 23 - ES0340031

    Pamplona, 31008

  • Investigator site 7 - ES0340028

    Seville, 41013

Other trials in Spain

Russia8 sites

  • Investigator site 54 - RU0070035

    Chelyabinsk, 454092

  • Investigator site 57 - RU0070029

    Kazan', 420111

  • Investigator site 55 - RU0070030

    Krasnodar, 350020

  • Investigator site 53 - RU0070032

    Rostov-on-Don, 344002

  • Investigator site 56 - RU0070031

    Saint Petersburg, 191123

  • Investigator site 65 - RU0070034

    Saint Petersburg, 197022

  • Investigator site 66 - RU0070028

    Saratov, 410012/410028

  • Investigator site 58 - RU0070033

    Yekaterinburg, 620076

Other trials in Russia

Italy7 sites

  • Investigator site 104 - IT0390039

    Catania, 95123

  • Investigator site 52 - IT0390031

    Florence, 50125

  • Investigator site 92 - IT0390030

    Genova, 16132

  • Investigator site 70 - IT0390038

    Perugia, 06129

  • Investigator site 43 - IT390005

    Roma, 00168

  • Investigator site 11 - IT0390006

    Rome, Lazio, 00167

  • Investigator site 71 - IT0390040

    Siena, 53100

Other trials in Italy

Greece6 sites

  • Investigator site 40 - GR0300004

    Athens, 11525

  • Investigator site 51 - GR0300006

    Athens, 16121

  • Investigator site 69 - GR0300001

    Athens, 16121

  • Investigator site 39 - GR0300003

    Chaïdári, 12462

  • Investigator site 50 - GR0300002

    Thessaloniki, 54643

  • Investigator site 41 - GR0300005

    Thessaloniki, 56429

Other trials in Greece

Ukraine6 sites

  • Investigator site 89 - UA3800017

    Dnipro, 49074

  • Investigator site 45 - UA3800023

    Ivano-Frankivsk, 76018

  • Investigator site 16 - UA3800020

    Kyiv, 4050

  • Investigator site 18 - UA3800019

    Kyiv, 4209

  • Investigator site 62 - UA3800021

    Lviv, 79013

  • Investigator site 17 - UA3800018

    Zaporizhzhya, 69063

Other trials in Ukraine

Bulgaria5 sites

  • Investigator site 30 - BG350012

    Pleven, 5800

  • Investigator site 31 - BG3590013

    Plovdiv, 4000

  • Investigator site 4 - BG3590010

    Sofia, 1431

  • Investigator site 2 - BG3590009

    Sofia, 1510

  • Investigator site 13 - BG3590011

    Sofia, 1606

Other trials in Bulgaria

Poland5 sites

  • Investigator site 26 - PL0480027

    Katowice, 40-081

  • Investigator site 72 - PL0480032

    Lodz, 90-647

  • Investigator site 95 - PL0480036

    Poznan, 60-369

  • Investigator site 27 - PL0480025

    Rzeszów, 35-055

  • Investigator site 28 - PL0480028

    Wroclaw, 50-566

Other trials in Poland

France4 sites

  • Investigator site 34 - FR0330028

    Bobigny, 93000

  • Investigator site 33 - FR0330027

    La Tronche, 38700

  • Investigator site 46 - FR0330029

    Rouen, 76031

  • Investigator site 32 - FR0330026

    Saint-Etienne, 42055

Other trials in France

Georgia4 sites

  • Investigator site 63 - GE9950014

    Tbilisi, 0159

  • Investigator site 132 - GE9950030

    Tbilisi, 0160

  • Investigator site 35 - GE9950013

    Tbilisi, 0162

  • Investigator site 36 - GE9950015

    Tbilisi, 0179

Other trials in Georgia

Hungary4 sites

  • Investigator site 133 - HU0360023

    Budapest, 1085

  • Investigator site 22 - HU0360003

    Debrecen, 4032

  • Investigator site 14 - HU0360001

    Pécs, 7632

  • Investigator site 42 - HU0360002

    Szeged, 6720

Other trials in Hungary

India4 sites

  • Investigator site 80 - IN0910002

    Ahmedabad, 380016

  • Investigator site 100 - IN0910001

    Chandigarh, 160012

  • Investigator site 90 - IN0910004

    Lucknow, 226005

  • Investigator site 91 - IN0910003

    Nagpur, 440003

Other trials in India

Serbia4 sites

  • Investigator site 116 - RS3810011

    Belgrade, 11000

  • Investigator site 122 - RS3810010

    Belgrade, 11000

  • Investigator site 115 - RS3810012

    Niš, 18000

  • Investigator site 114 - RS3810009

    Novi Sad, 21000

Other trials in Serbia

Australia3 sites

  • Investigator site 103 - AU0610013

    Melbourne, 3065

  • Investigator site 5 - AU0610007

    Parkville, Victoria, 3050

  • Investigator site 24 - AU0610006

    Sydney, New South Wales, 2217

Other trials in Australia

Romania3 sites

  • Investigator site 106 - RO0400013

    Bucharest, 011216

  • Investigator site 105 - RO0400014

    Cluj-Napoca, 400006

  • Investigator site 107 - RO0400015

    Iași, 700111

Other trials in Romania

Turkey (Türkiye)3 sites

  • Investigator site 76 - TR0900020

    Gaziantep, 27310

  • Investigator site 75 - TR0900012

    Istanbul, 34098

  • Investigator site 87 - TR0900011

    Istanbul, 34722

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Investigator site 117 - UK0440021

    Birmingham, B15 2GW

  • Investigator site 96 - UK0440022

    Bristol, BS2 8HW

  • Investigator site 135 - GB0440037

    Southampton, SO16 6YD

Other trials in United Kingdom

Israel1 site

  • Investigator site 12 - ISR9720002

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Pemphigus (Vulgaris or Foliaceus)

This is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to investigate the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK, and PD of efgartigimod PH20 SC in adult participants aged from 18 years with PV or PF. The trial comprises a screening period of up to 3 weeks, a treatment period of up to 30 weeks, and an 8-week follow-up period for participants who do not enroll into the open-label extension (OLE) trial ARGX-113-1905. The primary objective of the ARGX-113-1904 trial is to demonstrate the efficacy of subcutaneous administration of efgartigimod co-formulated with recombinant human hyaluronidase PH20 (Efgartigimod PH20 SC) compared to placebo in the treatment of participants with Pemphigus Vulgaris (PV). Secondary objectives are to also demonstrate the efficacy of efgartigimod PH20 SC in the treatment of participants with Pemphigus Foliaceus (PF), and to demonstrate early onset of action and a prednisone-sparing effect. After confirmation of eligibility, participants will be randomized in a 2: 1 ratio to receive efgartigimod PH20 SC or placebo

Being tested
efgartigimod PH20 SC, Placebo, prednisone
Medical subject headings
Pemphigus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • efgartigimod PH20 SCBiological

    Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer

  • PlaceboOther

    Subcutaneous injection of placebo

  • prednisoneDrug

    Oral prednisone tablets

Study groups in NCT04598451
Study groupRoleWhat they receive
efgartigimod PH20 SCExperimentalpatients receiving efgartigimod PH20 SC on top of prednisone
Receives: Biological: efgartigimod PH20 SC; Drug: prednisone
placeboExperimentalpatients receiving placebo on top of prednisone
Receives: Other: Placebo; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy

    Proportion of participants with pemphigus vulgaris who had CRmin within 30 weeks, 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.

    Measured: up to 30 weeks treatment period

Secondary outcomes (7)

  1. Number of Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy Within 30 Weeks

    Proportion of participants with pemphigus vulgaris and pemphigus foliaceus who had CRmin within 30 weeks, 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.

    Measured: up to 30 weeks treatment period

  2. Normalized Cumulative Prednisone Dose During the Treatment Period in Pemphigus Vulgaris Participants

    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

    Measured: Up to 30 weeks

  3. Time to Complete Clinical Remission (CR) in Pemphigus Vulgaris Participants

    Time to complete remission (absence of new lesions and complete healing of established lesions) in participants with pemphigus vulgaris

    Measured: Up to 30 weeks

  4. Time to Disease Control (DC) in Pemphigus Vulgaris (PV) Participants

    Time to disease control in participants with pemphigus vulgaris (Absence of new lesions and the start of healing of established lesions)

    Measured: Up to 30 weeks

  5. Normalized Cumulative Prednisone Dose During the Treatment Period in Pemphigus Vulgaris and Pemphigus Foliaceus Participants

    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

    Measured: Up to 30 weeks

  6. Time to Complete Clinical Remission (CR) in Pemphigus Vulgaris and Pemphigus Foliaceus Participants

    Time to complete remission (absence of new lesions and complete healing of established lesions) in participants with pemphigus vulgaris and pemphigus foliaceus

    Measured: Up to 30 weeks

  7. Time to Disease Control in Pemphigus Vulgaris and Pemphigus Foliaceus Participants

    Time to disease control in participants with pemphigus vulgaris and pemphigus foliaceus (Absence of new lesions and the start of healing of established lesions)

    Measured: Up to 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start1 Dec 2020
  3. Primary completion22 Aug 2023
  4. Study completion22 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04598451
Sponsor's protocol ID
ARGX-113-1904
Acronym
ADDRESS
Status last verified
Sep 2024
First submitted
8 Oct 2020
Last updated
1 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Joly P, Murrell DF, Aoyama Y, Caux F, De D, Flouri M, Goebeler M, Ji C, Kiritsi D, Pan M, Patsatsi A, Schmidt E, Vassileva S, Vandersarren L, Stoykov I, Verheesen P, Werth VP, Hall RP; ADDRESS Investigator Study Group. Efficacy and safety of subcutaneous efgartigimod with prednisone in moderate-to-severe pemphigus (ADDRESS): a global, phase III, randomised controlled, double-blind trial. Br J Dermatol. 2026 Oct 19;195(5):750-762. doi: 10.1093/bjd/ljag199.

    PubMed 42723554

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing efgartigimod PH20 SC and prednisone in people with Pemphigus Vulgaris and Pemphigus Foliaceus, run by argenx at 134 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, China, Germany, Japan, Spain and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Pemphigus Vulgaris (PV) Participants Who Achieve Complete Clinical Remission (CR) on Minimal Prednisone Therapy (time frame: up to 30 weeks treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04598451, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.

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