Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04612790) looked at a medicine called benralizumab compared to a placebo (a dummy treatment with no active ingredient) in people with a skin condition called bullous pemphigoid. In the first part of the trial (the "double-blind period," lasting up to 36 weeks), 34 people received benralizumab and 33 received placebo — neither the participants nor the researchers knew who was getting which treatment. A smaller follow-on "open-label extension" period then took place, in which 16 and 18 participants respectively continued or crossed over to benralizumab. The trial's main question was how many participants reached complete remission (no active disease) while off steroid tablets for at least two months by week 36. The reported data shows that for the main outcome, approximately 11.1% of participants in the benralizumab group met this remission definition at week 36, compared with about 5.3% in the placebo group. For the secondary outcomes, around 23.8% of the benralizumab group remained free of a disease relapse (a meaningful worsening of symptoms) up to week 36, versus about 19.8% in the placebo group. Both groups showed a reduction in a skin disease severity score (called the BPDAI activity score) from their starting point — the benralizumab group's score fell by about 53.3 points and the placebo group's by about 52.8 points, on a scale of 0 to 360. The reported data also shows that scores for itch (rated 0–30, with higher meaning worse) fell by about 5.6 points in the benralizumab group and about 16.6 points in the placebo group. Steroid tablet use over the 36 weeks was reported as approximately 71.4 mg/kg in the benralizumab group and 62.7 mg/kg in the placebo group. It is worth noting that a large proportion of participants did not complete the double-blind period (18 in the benralizumab group and 14 in the placebo group), and no participants were recorded as completing the open-label extension period, so the data should be interpreted with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Rare Disease Trial, Terminated
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- 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
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- 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.
Trial contact details on record
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percentage of Responders at Week 36
Other options
Data last synced from ClinicalTrials.gov: 18 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.