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A Study of PRN1008 in Patients With Pemphigus
A Study of PRN1008 in Patients With Pemphigus

NCT03762265

TerminatedPhase 3

Sponsor: Principia Biopharma, a Sanofi Company

Conditions: Pemphigus

Interventions: Rilzabrutinib, Placebo

Countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Croatia, France

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 efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the open-label extension period, eligible participants might continue in a long term extension (LTE) Period of 48 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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.
Locations (88)
  • Boca Raton, Florida, United States
  • Coral Gables, Florida, United States
  • Atlanta, Georgia, United States
  • Ann Arbor, Michigan, United States
  • Ann Arbor, Michigan, United States
  • Rochester, Minnesota, United States
  • Albuquerque, New Mexico, United States
  • New York, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Austin, Texas, United States
  • Murray, Utah, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • San Nicolás, Argentina
  • Fremantle, Western Australia, Australia
  • Melbourne, Australia
  • Sydney, Australia
  • Campinas, Brazil
  • Campo Grande, Brazil
  • Ribeirão Preto, Brazil
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Winnipeg, Manitoba, Canada
  • Osijek, Croatia
  • Zagreb, Croatia
  • Bobigny, France
  • + 58 more on CT.gov