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Bullous PemphigoidPhase 2/3BALLADNCT05267600

A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

A Phase 2/3 study testing efgartigimod PH20 SC and Prednisone in people with Bullous Pemphigoid, run by argenx at 129 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

ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bullous Pemphigoid
What is being tested?
efgartigimod PH20 SC and Prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
129 sitesin 21 countries
Study dates
9 Jun 2022to 13 Sep 2024
Phase
Phase 2/3
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

  • The participant is willing and able to do the following:
  • understand the requirements of the study
  • provide written informed consent
  • comply with the study protocol procedures.
  • The participant is male or female and has reached the age of consent at the time of signing the informed consent form (ICF).
  • Participants have clinical signs of BP.
  • Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and: Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before study intervention can be administered.
  • The full list of inclusion criteria can be found in the protocol.

Who cannot join

  • Other forms of pemphigoid or other autoimmune bullous diseases (AIBDs).
  • Received unstable dose of treatments known to cause or exacerbate BP for at least 4 weeks prior to the baseline visit
  • Use of BP treatments other than oral corticosteroids (OCS), topical corticosteroids (TCS), conventional immunosuppressants or dapsone.
  • Known contraindication to OCS therapy
  • Active, chronic or latent infection at screening
  • Positive COVID-19 test result at screening (testing performed if required per local regulations).
Show all 16Show fewer
  • History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of the IMP. Participants with 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
  • Clinical evidence of other significant serious diseases, have had a recent surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the patient at undue risk or prevent participants from complying with protocol requirements
  • Use of an investigational product within 3 months before the first dose of IMP
  • Previously participated in a clinical study with efgartigimod or currently participating in another interventional clinical study
  • Known hypersensitivity to any of the components of the administered treatments
  • Positive serum test at screening for an active infection: HBV, HCV, HIV
  • Current or history (ie, within 12 months of screening) of alcohol, drug, or medication abuse as assessed by the investigator
  • Pregnant or lactating females and those who intend to become pregnant during the study
  • Live or live-attenuated vaccine received <4 weeks before baseline visit
  • The full list of exclusion criteria can be found in the protocol.

Trial locations and contacts

129 sites in 21 countries.

129 sites in 21 countries

United States21 sites

  • Investigator site 50 - US0010149

    Ann Arbor, Michigan, 48109

  • Investigator site 2 - US0010087

    Boca Raton, Florida, 33428

  • Investigator site 5 - US0010088

    Buffalo, New York, 14203

  • Investigator site 10 - US0010153

    Castle Rock, Colorado, 80109

  • Investigator site 21 - US0010152

    Clearwater, Florida, 33756

  • Investigator site 4 - US0010137

    Fairborn, Ohio, 45324

  • Investigator site 6 - US0010138

    Fountain Valley, California, 92708

  • Investigator site 34 - US0010182

    Houston, Texas, 77004

  • Investigator site 115 - US0010157

    Jackson, Mississippi, 39216

  • Investigator site 85 - US0010159

    Lebanon, New Hampshire, 03756

  • Investigator site 35 - US0010156

    Louisville, Kentucky, 40217

  • Investigator site 1 - US0010017

    Miami, Florida, 33173

  • Investigator site 3 - US0010151

    Morgantown, West Virginia, 26505

  • Investigator site 92 - US0010150

    Murray, Utah, 84107

  • Investigator site 93 - US0010169

    New York, New York, 10016

  • Investigator site 74 - US0010178

    Phoenix, Arizona, 85006

  • Investigator site 25 - US0010158

    Pittsburgh, Pennsylvania, 15213

  • Investigator site 121 - US0010092

    Redwood City, California, 94063

  • Investigator site 72 - US0010186

    Santa Monica, California, 90404

  • Investigator site 73 - US0010098

    St Louis, Missouri, 63110

  • Investigator site 13 - US0010155

    West Lafayette, Indiana, 47906

Other trials in United States

China15 sites

  • Investigator site 111 - CN0860064

    Beijing, 100006

  • Investigator site 91 - CN0860017

    Beijing

  • Investigator site 95 - CN0860018

    Chengdu

  • Investigator site 116 - CN0860027

    Chongqing, 400016

  • Investigator site 108 - CN0860023

    Fujian, 350004

  • Investigator site 107 - CN0860021

    Guangzhou, 510091

  • Investigator site 110 - CN0860053

    Guanzhou, 510080

  • Investigator site 128 - CN0860097

    Hefei

  • Investigator site 124 - CN0860098

    Nanchang, 330000

  • Investigator site 94 - CN0860066

    Nanyang

  • Investigator site 127 - CN860020

    Shanghai, 200025

  • Investigator site 123 - CN0860095

    Shanghai, 200435

  • Investigator site 122 - CN0860065

    Ürümqi, 830054

  • Investigator site 109 - CN0860025

    Wuhan, 430031

  • Investigator site 126 - CN0860026

    Zhengzhou, 450003

Other trials in China

Italy12 sites

  • Investigator site 65 - IT0390055

    Bologna, 40138

  • Investigator site 43 - IT0390060

    Brescia, 25132

  • Investigator site 78 - IT0390039

    Catania, 95123

  • Investigator site 47 - IT0390031

    Florence, 50122

  • Investigator site 86 - IT0390067

    Florence, 50122

  • Investigator site 81 - IT0390030

    Genova, 16132

  • Investigator site 77 - IT0390062

    Milan, 20122

  • Investigator site 119 - IT0390066

    Parma, 43126

  • Investigator site 64 - IT0390061

    Pavia, 27100

  • Investigator site 23 - IT0390006

    Roma, 00167

  • Investigator site 42 - IT0390005

    Roma, 00168

  • Investigator site 30 - IT0390040

    Siena, 53100

Other trials in Italy

Germany11 sites

  • Investigator site 46 - DE0490039

    Berlin, 10117

  • Investigator site 54 - DE0490030

    Dresden, 01307

  • Investigator site 80 - DE0490041

    Düsseldorf, 40225

  • Investigator site 57 - DE0490046

    Erlangen, 91054

  • Investigator site 51 - DE0490008

    Essen, 45147

  • Investigator site 52 - DE0490024

    Frankfurt am Main, 60590

  • Investigator site 53 - DE0490023

    Freiburg im Breisgau, 79104

  • Investigator site 56 - DE0490028

    Kiel, 24105

  • Investigator site 45 - DE0490001

    Marburg, 35043

  • Investigator site 75 - DE0490047

    München, 85006

  • Investigator site 55 - DE0490026

    Würzburg, 97080

Other trials in Germany

Japan11 sites

  • Investigator site 103 - JP0810070

    Kumamoto, 860-8556

  • Investigator site 99 - JP0810050

    Kurume, 830-0011

  • Investigator site 104 - JP0810071

    Maebashi, 371-8511

  • Investigator site 100 - JP0810046

    Nagakute, 480-1195

  • Investigator site 129 - JP0810073

    Niigata, 951-8520

  • Investigator site 101 - JP0810049

    Osaka, 545-8586

  • Investigator site 102 - JP0810069

    Ōsaka-sayama, 589-8511

  • Investigator site 112 - JP0810045

    Sapporo, 060-8648

  • Investigator site 105 - JP0810067

    Sendai, 980-8574

  • Investigator site 98 - JP0810043

    Tokyo, 113-8431

  • Investigator site 106 - JP0810068

    Yokohama, 236-0004

Other trials in Japan

Spain10 sites

  • Investigator site 32 - ES0340050

    Badalona, 08916

  • Investigator 24 - ES0340051

    Barcelona, 08003

  • Investigator site 8 - ES0340053

    Granada, 18016

  • Investigator site 12 - ES0340025

    Madrid, 28034

  • Investigator 20 - ES0340029

    Madrid, 28041

  • Investigator site 31 - ES0340057

    Málaga, 29009

  • Investigator site 49 - ES0340058

    Manises, 46940

  • Investigator site 48 - ES0340059

    Mieres, 33611

  • Investigator site 9 - ES0340052

    Seville, 41009

  • Investigator site 70 - ES0340061

    Valencia, 46017

Other trials in Spain

Greece6 sites

  • Investigator site 60 - GE0300004

    Athens, 11525

  • Investigator site 62 - GE0300006

    Athens, 11525

  • Investigator site 58 - GR0300001

    Athens, 16121

  • Investigator site 76 - GR030003

    Chaïdári, 12462

  • Investigator site 61 - GE0300002

    Thessaloniki, 54643

  • Investigator site 59 - GR0300005

    Thessaloniki, 56429

Other trials in Greece

Poland5 sites

  • Investigator site 17 - PL0480047

    Lodz, 90-647

  • Investigator site 79 - PL0480025

    Rzeszów, 35055

  • Investigator site 83 - PL0480050

    Warsaw, 00-716

  • Investigator site 18 - PL0480048

    Wroclaw, 50-220

  • Investigator site 19 - PL0480046

    Wroclaw, 51-685

Other trials in Poland

Czechia4 sites

  • Investigator site 97 - CZ4200015

    Brno, 656 91

  • Investigator site 118 - CZ4200016

    Hradec Králové, 500 05

  • Investigator site 117 - CZ4200013

    Plzen-Bory, 13, 301 00

  • Investigator site 96 - CZ4200012

    Prague, 180 81

Other trials in Czechia

Israel4 sites

  • Investigator site 39 - IL9720003

    Afula, 1834111

  • Investigator site 63 - IL9720018

    Haifa, 3109601

  • Investigator site 41 - IL9720001

    Ramat Gan, 5262100

  • Investigator site 40 - IL9720002

    Tel Aviv, 64239

Other trials in Israel

Serbia4 sites

  • Investigator 68 - RS381011

    Belgrade, 110000

  • Investigator site 84 - RS3810010

    Belgrade, 11040

  • Investigator site 67 - RS3810012

    Niš, 18000

  • Investigator site 69 - RS3810009

    Novi Sad, 21000

Other trials in Serbia

Australia3 sites

  • Investigator site 36 - AU0610013

    Fitzroy, 3065

  • Investigator site 27 - AU0610006

    Kogarah, 2217

  • Investigator site 125 - AU0610019

    Woolloongabba, 4102

Other trials in Australia

Bulgaria3 sites

  • Investigator site 28 - BG3590018

    Sofia, 1407

  • Investigator site 14 - BG3590010

    Sofia, 1431

  • Investigator site 15 - BG3590020

    Stara Zagora, 6003

Other trials in Bulgaria

Croatia3 sites

  • Investigator site 22 - HR3850003

    Split, 21000

  • Investigator site 16 - HR3850002

    Zagreb, 10000

  • Investigator site 37 - HR3850001

    Zagreb, 10000

Other trials in Croatia

Hungary3 sites

  • Investigator site 26 - HU0360023

    Budapest, 1085

  • Investigator site 11 - HU0360003

    Debrecen, 4032

  • Investigator site 7 - HU0360008

    Pécs, 7632

Other trials in Hungary

Latvia3 sites

  • Investigator site 87 - LV3710005

    Riga, 1001

  • Investigator site 82 - LV3710003

    Riga, 1003

  • Investigator site 88 - LV3710004

    Riga, 1003

Other trials in Latvia

Slovakia3 sites

  • Investigator site 113 - SK4210002

    Bratislava, 4210002

  • Investigator site 120 - SK4210004

    Košice, 040 11

  • Investigator site 114 - SK4210003

    Trnava, 91702

Other trials in Slovakia

United Kingdom3 sites

  • Investigator site 33 - UK0440022

    Bristol, BS2 8HW

  • Investigator site 71 - UK0440036

    London

  • Investigator site 44 - UK0440037

    Southampton, SO16 6YD

Other trials in United Kingdom

France2 sites

  • Investigator site 38 - FR0330040

    Nice, 06202

  • Investigator site 29 - FR0330029

    Rouen, 76031

Other trials in France

Romania2 sites

  • Investigator site 90 - RO0400014

    Cluj-Napoca, 400006

  • Investigator site 89 - RO0400015

    Iași, 700111

Other trials in Romania

Netherlands1 site

  • Investigator site 66 - NL0310015

    Groningen, 9713

Other trials in Netherlands

About this study

Official title: A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of efgartigimod PH20 SC administered via subcutaneous (SC) injection in adult participants with moderate to severe BP. This study intends to demonstrate that efgartigimod is an effective and safe treatment for BP, providing participants with control of disease activity (CDA) and eventually remission while reducing their cumulative exposure to OCS.

study will consist of 2 parts:

Read more
  • Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP.
  • Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate, larger group of participants with BP.

An interim analysis will be performed during part A (on data obtained through week 26 for all Part A participants) to assess the primary endpoint and several secondary endpoints, confirm the appropriate sample size for part B of the study, and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP (futility analysis).

Being tested
efgartigimod PH20 SC, placebo, Prednisone
Medical subject headings
Pemphigoid, Bullous

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 coformulated with rHuPH20, a permeation enhancer

  • placeboOther

    Subcutaneous injection of placebo coformulated with rHuPH20, a permeation enhancer

  • PrednisoneDrug

    Oral Prednisone

Study groups in NCT05267600
Study groupRoleWhat they receive
efgartigimod PH20 SCExperimentalparticipants receiving efgartigimod PH20 SC on top of Prednisone
Receives: Biological: efgartigimod PH20 SC; Drug: Prednisone
placebo PH20 SCPlacebo comparatorparticipants receiving placebo PH20 SC 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 Participants With CRoff 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.

    Measured: at week 36

Secondary outcomes (23)

  1. Cumulative OCS Dose

    OCS = oral corticosteroid

    Measured: up to week 36

  2. Number of Participants Who Achieve an IGA-BP Score of 0 While Off OCS Therapy for ≥8 Weeks 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

    Measured: at week 36

  3. Number of Participants With CDA Who Remained Free of Relapse Through 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.

    Measured: up to week 36

  4. Number of Participants With CRmin 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).

    Measured: at week 36

  5. Change From Baseline to Week 36 in the 24-Hour Average Itch NRS Score

    Itch NRS = Itch Numerical Rating Scale. The Itch NRS scores range from 0-10 with 10 representing the worst imaginable itch.

    Measured: up to week 36

  6. Changes From Baseline in the BPDAI Total Activity Score

    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).

    Measured: up to week 36

  7. Time to CDA

    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.

    Measured: up to week 36

  8. Time to CR

    CR = complete remission, the absence of new lesions, complete healing of existing lesions, and absence of pruritus.

    Measured: up to week 36

  9. Time to CRmin

    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).

    Measured: up to week 36

  10. Time to CRoff/PRoff

    CRoff= complete remission (the absence of new lesions, complete healing of existing lesions, and absence of pruritus) while receiving efgartigimod PH20 SC or placebo and being off oral corticosteroid therapy for at least 8 weeks. PRoff = partial remission (the presence of only new transient lesions) while receiving efgartigimod PH20 SC or placebo and being off oral corticosteroid therapy for at least 8 weeks.

    Measured: up to week 36

  11. Time to CRoff

    CRoff is defined as the absence of new lesions, complete healing of existing lesions, and absence of pruritus while being off OCS therapy for ≥8 weeks.

    Measured: up to week 36

  12. Time From CDA to Achieve Relapse

    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.

    Measured: up to week 36

  13. Number of Participants Who Receive Rescue Therapy Before Week 36

    Measured: at week 36

  14. The AIS From the GTI

    The Aggregate Improvement Score (AIS) from the Glucocorticoid Toxicity Index (GTI) can range from -346 to 439 with a higher score representing greater corticosteroid toxicity. If a study drug is effective at lowering greater corticosteroid toxicity over time, the score will be lower.

    Measured: up to week 36

  15. The CWS From the GTI

    The Cumulative Worsening Score (CWS) from the Glucocorticoid Toxicity Index (GTI) can range from 0 to 439 with a higher score representing greater corticosteroid toxicity.

    Measured: up to week 36

  16. EQ-5D-5L VAS Scores Over Time

    The EuroQol 5-Dimension 5-Level Visual Analog Scale (EQ-5D-5L VAS) scores range from 0-100 with 0 representing the worst health.

    Measured: up to week 36

  17. DLQI Scores Over Time

    Dermatology Life Quality Index (DLQI) assess the participant's perception of the impact of skin diseases on different aspects of their health-related QoL. Scores range from 0 to 30 with a higher score representing a worse quality of life.

    Measured: up to week 36

  18. ABQoL Scores Over Time

    Autoimmune Bullous Disease Quality of Life Index (ABQoL) questionnaire assesses the impact of Autoimmune Bullous Disease and their therapies on the daily life of patients. Scores range from 0 to 51 with a higher score representing a worse quality of life.

    Measured: up to week 36

  19. Efgartigimod Serum Concentrations

    Measured: up to week 36

  20. Percent Change of Total IgG Serum Levels From Baseline Over Time

    Measured: up to 36 weeks

  21. Percent Change of Anti-BP180 and Anti-BP230 Antibodies From Baseline Over Time

    Measured: up to 36 weeks

  22. Incidence of Antidrug Antibodies Against Efgartigimod and Antibodies Produced Against rHuPH20

    Measured: up to 46 weeks

  23. Number of Participants (or Their Caregivers) Who Are Determined by Site Staff to be Sufficiently Competent in (Self-)Administering Efgartigimod PH20 SC

    Measured: up to week 32

Timeline

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

  1. First posted4 Mar 2022
  2. Study start9 Jun 2022
  3. Primary completion13 Sep 2024
  4. Study completion13 Sep 2024

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05267600
Sponsor's protocol ID
ARGX-113-2009
Acronym
BALLAD
Status last verified
Sep 2025
First submitted
14 Feb 2022
Last updated
23 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing efgartigimod PH20 SC and Prednisone in people with Bullous Pemphigoid, run by argenx at 129 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 8 inclusion and 16 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 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, China, Italy, Germany, Japan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Oct 2025). 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 Participants With CRoff at Week 36 (time frame: at week 36). 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 NCT05267600.

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 23 Oct 2025.

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