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A phase 2/3 study of efgartigimod PH20 SC in adult participants with bullous pemphigoid
EU CTIS ID: 2023-508645-40-00
What this study is testing
To evaluate the efficacy of efgartigimod PH20 SC on achieving sustained remission in the treatment of participants with bullous pemphigoid (BP)
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The participant is willing and able to do the following: a. understand the requirements of the study b. provide written informed consent c. comply with the study protocol procedures.
- The participant is male or female and has reached the local legal age of consent at the time of signing the informed consent form (ICF)
- Participants have clinical signs of BP.
- The participant agrees to use contraceptive measures consistent with local regulations. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving IMP.
You likely can't join if
- Other forms of pemphigoid or other autoimmune bullous diseaes (AIBDs)
- 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 with any of the following conditions: a. HBV b. HCV c. 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
See the full eligibility criteria
- The participant is willing and able to do the following: a. understand the requirements of the study b. provide written informed consent c. comply with the study protocol procedures.
- The participant is male or female and has reached the local legal age of consent at the time of signing the informed consent form (ICF)
- Participants have clinical signs of BP.
- The participant agrees to use contraceptive measures consistent with local regulations. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving IMP.
- Other forms of pemphigoid or other autoimmune bullous diseaes (AIBDs)
- 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 with any of the following conditions: a. HBV b. HCV c. 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
- Received unstable dose of treatments known to cause or exacerbate BP for at least 4 weeks prior 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 before their participation in the study: a. Basal cell or squamous cell skin cancer b. Carcinoma in situ of the cervix c. Carcinoma in situ of the breast d. 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 or 5 half-lives (whichever is longer) before the first dose of IMP
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- Israel
- Japan
- Australia
- United States
- United Kingdom
- Canada
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; Israel; Japan; Australia; United States; United Kingdom and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.