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A Study of PRN1008 in Patients With Pemphigus

NCT03762265 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2023-08-02

Study results available
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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 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.

Conditions

  • Pemphigus

Interventions

DRUG

Rilzabrutinib

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Placebo

Pharmaceutical form: Tablet Route of administration: Oral

Sponsors & Collaborators

  • Principia Biopharma, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2021-07-30
Completion
2021-12-17
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Poland
  • Serbia
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03762265 on ClinicalTrials.gov