A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD)
Bullous Pemphigoid
About this trial
This is an interventional treatment trial for Bullous Pemphigoid
Eligibility Criteria
Inclusion Criteria:
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 by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and:
Male participants:
* Must agree to use an acceptable method of contraception from the time that the ICF is signed until the date of their last dose of IMP.
Female participants:
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before study intervention can be administered.
- WOCBP must agree to use at least one of the contraception methods identified in the protocol from the time that the ICF is signed until the date of their last dose of IMP.
The full list of inclusion criteria can be found in the protocol.
Exclusion Criteria:
- 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 or chronic 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
- Use of an investigational product within 3 months before the first dose of IMP
- Previously participated in a clinical study with efgartigimod
- 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
- Pregnant or lactating females and those who intend to become pregnant during the study
The full list of exclusion criteria can be found in the protocol.
Sites / Locations
- Investigator site 74 - US0010178Recruiting
- Investigator site 6 - US0010138Recruiting
- Investigator site 121 - US0010092
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- Investigator site AU0610019
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- Investigator site 122 - CN0860065
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- Investigator site 97 - CZ4200015Recruiting
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- Investigator site 64 - IT0390061Recruiting
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- Investigator site 30 - IT0390040Recruiting
- Investigator site 103 - JP0810070Recruiting
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- Investigator site 102 - JP0810069Recruiting
- Investigator site 87 - LV3710005Recruiting
- Investigator site 82 - LV3710003Recruiting
- Investigator site 88 - LV3710004Recruiting
- Investigator site 66 - NL0310015Recruiting
- Investigator site 79 - PL0480025Recruiting
- Investigator site 83 - PL0480050Recruiting
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- Investigator site 19 - PL0480046Recruiting
- Investigator site 17 - PL0480047Recruiting
- Investigator site 90 - RO0400014Recruiting
- Investigator site 89 - RO0400015Recruiting
- Investigator 68 - RS381011Recruiting
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- Investigator site 69 - RS3810009Recruiting
- Investigator site 113 - SK4210002Recruiting
- Investigator site 120 - SK4210004
- Investigator site 114 - SK4210003Recruiting
- Investigator site 32 - ES0340050Recruiting
- Investigator 24 - ES0340051Recruiting
- Investigator site 8 - ES0340053Recruiting
- Investigator site 12 - ES0340025Recruiting
- Investigator 20 - ES0340029Recruiting
- Investigator site 49 - ES0340058Recruiting
- Investigator site 48 - ES0340059
- Investigator site 31 - ES0340057Recruiting
- Investigator site 9 - ES0340052Recruiting
- Investigator site 70 - ES0340061Recruiting
- Investigator site 33 - UK0440022Recruiting
- Investigator site 71 - UK0440036Recruiting
- Investigator site 44 - UK0440037Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
efgartigimod PH20 SC
placebo PH20 SC
participants receiving efgartigimod PH20 SC on top of Prednisone
participants receiving placebo PH20 SC on top of Prednisone