Status:
COMPLETED
A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
Lead Sponsor:
argenx
Conditions:
Bullous Pemphigoid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05267600
Start Date
June 9 2022
End Date
September 13 2024
Last Update
October 23 2025
Active Locations (129)
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1
Investigator site 74 - US0010178
Phoenix, Arizona, United States, 85006
2
Investigator site 6 - US0010138
Fountain Valley, California, United States, 92708
3
Investigator site 121 - US0010092
Redwood City, California, United States, 94063
4
Investigator site 72 - US0010186
Santa Monica, California, United States, 90404