NCT01920477

Who might be able to join this trial:

• 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:

• 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.