Clinical Trials

Inclusion Criteria:

• Male or female aged 18-80 years old with moderate to severe pemphigus, newly diagnosed or relapsing pemphigus vulgaris (PD) or pemphigus foliaceus (PF); positive anti-dsg1 or 3 autoantibody titer.
• Laboratory clearance with adequate hematologic, hepatic, and renal function.
• Female patients who are of reproductive potential must agree for the duration of active treatment to use an effective means of contraception.
• Able to provide written informed consent.

Exclusion Criteria: 

• Previous use of a Bruton's tyrosine kinase (BTK) inhibitor.
• Pregnant or lactating women.
• Clinically significant abnormalities, ECG findings or poorly controlled atrial fibrillation.
• A history of malignancy of any type, other than surgically excised non-melanoma skin cancers or in situ cervical cancer within 5 years before Day 1.
• Use of excluded medications within specified timeframes (proton pump inhibitors, immunologic response modifiers, investigational drugs, CYP3A inducers or inhibitors, CYP3A-sensitive substrates).
• History of drug abuse or excessive alcohol use.
• Blood or blood product donation of a unit or more within 4 weeks.
• Live vaccine within 28 days prior to Day 1 or plan to receive one during the trial.
• Clinically significant diseases, positive at Screening of HIV and hepatitis A and B, history of serious infections and active latent tuberculosis (TB).