Status:
TERMINATED
A Study of PRN1008 in Patients With Pemphigus
Lead Sponsor:
Principia Biopharma, a Sanofi Company
Conditions:
Pemphigus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment \[BT\] period) followed by an open-label extension \[OLE\] period intended to evaluate the effi...
Detailed Description
A total of 131 male or female participants with newly diagnosed or relapsing moderate to severe pemphigus (pemphigus vulgaris \[PV\] or pemphigus foliaceus \[PF\]) were enrolled in the trial worldwide...
Eligibility Criteria
Inclusion
- Male or female participants, aged 18 to 80 years old with moderate to severe, newly diagnosed or relapsing PV or PF, with a clinical presentation and histopathology consistent with PV or PF.
- Positive circulating anti-desmoglein 1 (anti-dsg1) or 3 autoantibody titer.
- At screening, pemphigus disease area index score of at least 9 points for relapsing participants or at least 15 points for newly diagnosed participants.
- Adequate hematologic, hepatic, and renal function.
- Effective means of contraception.
Exclusion
- Suspected paraneoplastic pemphigus and other forms of pemphigus that were not PV or PF.
- Previous use of a Bruton tyrosine kinase inhibitor.
- Pregnant or lactating women.
- Electrocardiogram clinically significant abnormalities.
- A history of malignancy of any type within 5 years before Day 1, other than surgically excised non-melanoma skin cancers or in situ cervical cancer.
- Use of immunologic response modifiers as concomitant medication and with the washout period.
- Use of proton pump inhibitor drugs such as omeprazole and esomeprazole within 3 days of Day 1.
- Concomitant use of known strong-to-moderate inducers or inhibitors of cytochrome P450 3A (CYP3A) within 3 days or 5 half-lives (whichever is longer) of Day 1
- Use of CYP3A-sensitive substrate drugs.
- Had received any investigational drug within the 30 days before Day 1.
- History of drug abuse within the previous 12 months.
- Alcoholism or excessive alcohol use.
- Any other clinically significant disease, condition or medical history that, in the opinion of the Investigator, would interfere with participant safety, trial evaluations, and/or trial procedures.
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2021
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT03762265
Start Date
January 8 2019
End Date
December 17 2021
Last Update
August 2 2023
Active Locations (88)
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1
Central Recruiting (Principia Biopharma)
Boca Raton, Florida, United States, 33433
2
Central Recruiting (Principia Biopharma)
Coral Gables, Florida, United States, 33134
3
Central Recruiting (Principia Biopharma)
Atlanta, Georgia, United States, 30322
4
Central Recruiting (Principia Biopharma)
Ann Arbor, Michigan, United States, 48103