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 enrolled 35 people in total — 17 received a medicine called ofatumumab and 18 received a placebo (a dummy treatment with no active ingredient). The trial was studying a skin condition and looking at whether participants could reach a point where their disease was under control ("remission") while taking only a low dose of steroid tablets (10 mg per day or less). The trial ran to 60 weeks, and only a small number of participants — 2 in the ofatumumab group and 1 in the placebo group — completed it in full. The reported data shows that for the main goal of the trial — the number of participants who achieved a sustained (lasting) remission on a low steroid dose all the way through to week 60 — the answer was zero in both groups. For a related main measure, the total number of days participants spent in remission while on a low steroid dose was reported as 168 days on average for the ofatumumab group and 122 days for the placebo group. For one of the secondary (additional) goals, the reported data shows that approximately 17.6% of participants in the ofatumumab group and 5.6% in the placebo group achieved remission on a low steroid dose at the week 60 mark. The "time to remission" figures were listed as not able to be calculated in either group. One secondary measure — whether anyone achieved remission while completely off steroids — could not be analysed at all because no participants were able to stop their steroid medication during the trial. The reported data shows this was a relatively small trial with a high number of participants who did not complete the full study period, which is noted in the results as submitted. 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 between 18 and 70 years old and have been officially diagnosed with Pemphigus Vulgaris (PV) for more than 2 months but less than 10 years.
- You have a history of a skin biopsy that confirmed your PV diagnosis, or you are willing to have one done during the screening period.
- You have had at least one occasion in the past where your PV got worse or came back even while taking steroid tablets (prednisone/prednisolone) at a dose higher than 10 mg per day, and your doctor had to adjust your treatment as a result.
- Your blood tests during screening show specific antibodies (anti-Dsg3) that are consistent with a PV diagnosis.
- You have been taking a stable dose of steroid tablets (between 20 mg/day and 120 mg/day, or based on your body weight) for at least 2 weeks before joining the trial.
- Your PV has been under control, meaning no new skin sores or blisters have appeared for at least 2 weeks.
- If you are a woman, you are either past menopause (confirmed by blood tests if needed) or have had a surgical procedure that means you cannot become pregnant.
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 been diagnosed with a different type of pemphigus or another autoimmune blistering skin disease (other than Pemphigus Vulgaris).
- You have had an allergic reaction or significant side effects to any ingredient in the study drug, or to antihistamines (such as cetirizine) or paracetamol/acetaminophen (such as Tylenol).
- You were previously treated with a medicine called rituximab but your PV did not come under control within 6 months of starting it.
- You have recently taken certain medicines that suppress or modify the immune system within specific time periods set by the trial (confirm with trial site).
- You have a history of serious infections, or currently have one (in Japan, this also specifically includes certain lung infections).
- You have a current or past history of cancer, unless it was a very early-stage cervical cancer, a non-invasive skin cancer, or a cancer for which you have been fully cancer-free for more than 5 years.
- You have another serious, uncontrolled medical condition that could affect your safety, your ability to take part reliably, or that requires steroid treatment for a reason other than PV.
- You have taken part in another drug trial or used an experimental treatment within approximately 4 weeks or more before screening (confirm exact timeframe with trial site).
- Your heart tracing (ECG) shows a significant abnormality or a specific heart rhythm measurement that is too high (confirm with trial site).
- You are currently breastfeeding.
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
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
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 2 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy; Duration of Remission on Minimal Steroid Therapy
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.