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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Bullous Pemphigoid

In brief

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: * 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).

Key facts

Study ID: NCT05267600
Run by: argenx
People needed: 98
Starts: 2022-06-09
Expected to finish: 2024-09-13
Last updated by the study team: 2025-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).
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.

Where it is running

Investigator site 6 - US0010138 — Fountain Valley, California, United States
Investigator site 121 - US0010092 — Redwood City, California, United States
Investigator site 72 - US0010186 — Santa Monica, California, United States
Investigator site 10 - US0010153 — Castle Rock, Colorado, United States
Investigator site 2 - US0010087 — Boca Raton, Florida, United States
Investigator site 21 - US0010152 — Clearwater, Florida, United States
Investigator site 1 - US0010017 — Miami, Florida, United States
Investigator site 13 - US0010155 — West Lafayette, Indiana, United States
Investigator site 35 - US0010156 — Louisville, Kentucky, United States
Investigator site 50 - US0010149 — Ann Arbor, Michigan, United States
Investigator site 115 - US0010157 — Jackson, Mississippi, United States
Investigator site 73 - US0010098 — St Louis, Missouri, United States
Investigator site 85 - US0010159 — Lebanon, New Hampshire, United States
Investigator site 5 - US0010088 — Buffalo, New York, United States
Investigator site 93 - US0010169 — New York, New York, United States
Investigator site 4 - US0010137 — Fairborn, Ohio, United States
Investigator site 25 - US0010158 — Pittsburgh, Pennsylvania, United States
Investigator site 34 - US0010182 — Houston, Texas, United States
Investigator site 92 - US0010150 — Murray, Utah, United States
Investigator site 3 - US0010151 — Morgantown, West Virginia, United States
Investigator site 36 - AU0610013 — Fitzroy, Australia
Investigator site 27 - AU0610006 — Kogarah, Australia
Investigator site 125 - AU0610019 — Woolloongabba, Australia
Investigator site 28 - BG3590018 — Sofia, Bulgaria
Investigator site 74 - US0010178 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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