A Study of PRN1008 in Patients With Pemphigus

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Pemphigus

In brief

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.

Key facts

Study ID: NCT03762265
Run by: Principia Biopharma, a Sanofi Company
People needed: 131
Starts: 2019-01-08
Expected to finish: 2021-12-17
Last updated by the study team: 2023-08-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Central Recruiting (Principia Biopharma) — Coral Gables, Florida, United States
Central Recruiting (Principia Biopharma) — Atlanta, Georgia, United States
Central Recruiting (Principia Biopharma) — Ann Arbor, Michigan, United States
Central Recruiting (Principia Biopharma) — Ann Arbor, Michigan, United States
Central Recruiting (Principia Biopharma) — Rochester, Minnesota, United States
Central Recruiting (Principia Biopharma) — Albuquerque, New Mexico, United States
Central Recruiting (Principia Biopharma) — New York, New York, United States
Central Recruiting (Principia Biopharma) — New York, New York, United States
Central Recruiting (Principia Biopharma) — Chapel Hill, North Carolina, United States
Central Recruiting (Principia Biopharma) — Durham, North Carolina, United States
Central Recruiting (Principia Biopharma) — Cleveland, Ohio, United States
Central Recruiting (Principia Biopharma) — Austin, Texas, United States
Central Recruiting (Principia Biopharma) — Murray, Utah, United States
Central Recruiting (Principia Biopharma) — Buenos Aires, Argentina
Central Recruiting (Principia Biopharma) — Buenos Aires, Argentina
Central Recruiting (Principia Biopharma) — San Nicolás, Argentina
Central Recruiting (Principia Biopharma) — Fremantle, Western Australia, Australia
Central Recruiting (Principia Biopharma) — Melbourne, Australia
Central Recruiting (Principia Biopharma) — Sydney, Australia
Central Recruiting (Principia Biopharma) — Campinas, Brazil
Central Recruiting (Principia Biopharma) — Campo Grande, Brazil
Central Recruiting (Principia Biopharma) — Ribeirão Preto, Brazil
Central Recruiting (Principia Biopharma) — Pleven, Bulgaria
Central Recruiting (Principia Biopharma) — Plovdiv, Bulgaria
Central Recruiting (Principia Biopharma) — Boca Raton, Florida, United States

Full record on ClinicalTrials.gov

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