A Study of PRN1008 in Patients With Pemphigus

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of oral PRN1008 in moderate to severe pemphigus.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Julia Lehman, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20461207

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