Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
argenx
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The participant is willing and able to do the following:
1. understand the requirements of the study
2. provide written informed consent
3. 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.
You may not be 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
Clareo Health | A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
