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NCT04612790

NCT04612790
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have been diagnosed with bullous pemphigoid (a blistering skin condition), confirmed through skin biopsy, immune staining of the skin, and a blood test
  • Your bullous pemphigoid symptoms are active and scored at a certain level of severity at both your screening and randomisation visits (confirm with trial site)
  • Your doctor considers you a suitable candidate for steroid tablet treatment
  • You are able to complete health questionnaires on a tablet or handheld device (exceptions may be made if you have a condition affecting your hands, fingers, or vision — confirm with trial site)
  • You are male or female
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at screening and agree to use a highly effective form of contraception throughout the study and for 12 weeks after your last dose (accepted methods include hormonal contraception, an IUD, tubal ligation, abstinence, or a vasectomised partner)
  • If you are a woman who cannot become pregnant (due to surgical sterilisation or menopause), you may still be eligible

Who may not be able to join:

  • You have a less common or unusual form of bullous pemphigoid (such as mucous membrane involvement, drug-induced bullous pemphigoid, or certain other related conditions)
  • You have another serious or unstable health condition that, in the doctor's opinion, could affect your safety or the study results (such as heart, liver, kidney, or psychiatric conditions)
  • You have had cancer in the past 5 years — although some exceptions apply, such as certain fully treated skin cancers or cervical cancer in remission for at least 12 months (confirm with trial site)
  • You have ever had a severe allergic reaction (anaphylaxis) to a biologic medicine or vaccine
  • You have had a parasitic worm infection in the past 24 weeks that has not been successfully treated
  • You have significant abnormal results from physical checks, blood tests, or heart tests during screening that concern the study doctor
  • You currently have active liver disease (note: stable, chronic hepatitis B or C may be acceptable — confirm with trial site)
  • You have liver enzyme levels (ALT or AST) that are 3 or more times above the normal range
  • You have a known immune deficiency disorder, or you test positive for HIV
  • You have taken certain immune-suppressing medicines (such as methotrexate, cyclosporine, or azathioprine) within approximately the past 4 weeks or longer
  • You have received immunoglobulin or blood products within the past 30 days
  • You have received a biologic medicine (marketed or experimental) within the past 4 months or longer (some exceptions may apply — confirm with trial site)
  • You have a known allergy to any ingredient in the study medicine
  • You have received a live vaccine within 30 days before joining the study
  • You have previously been treated with benralizumab (also known as FASENRA or MEDI-563)
  • You have recently changed or started allergen immunotherapy (allergy shots) within the past 30 days
  • You have a major planned surgery scheduled during the study period
  • You have already taken part in this study before
  • You are currently enrolled in another clinical trial involving an experimental medicine or device
  • You are involved in planning or running this study
  • You are currently pregnant, breastfeeding, or lactating (for women only)
  • You are unable to complete health questionnaires due to a cognitive condition such as dementia

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Terminated
Phase
Phase 3
Sponsor
AstraZeneca
Registry
clinicaltrials_gov
Start date
31 March 2021
Est. completion
26 October 2023

Where this trial is recruiting

🇦🇺 Australia 🇧🇬 Bulgaria 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇪🇸 Spain 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Responders at Week 36

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov