Date: 2017-07-27
Type of
information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Boehringer Ingelheim (Germany)
Product: BI 695501 (biosimilar version of adalimumab Humira®)
Action
mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor.
Disease: psoriasis
Therapeutic
area: Autoimmune diseases - Dermatological diseases
Country:
Trial
details:
- The VOLTAIRE-X study is being conducted in 240 patients with moderate-to-severe chronic plaque psoriasis. The study will compare the pharmacokinetics and clinical outcomes between patients receiving Humira® continuously, versus those who switch repeatedly between Humira® and BI 695501. The study will also assess safety, immunogenicity and efficacy. (NCT03210259)
Latest
news:
- • On July 27, 2017, Boehringer Ingelheim announced that the first patient has been enrolled into its VOLTAIRE-X interchangeability study. The goal of the study is to demonstrate that BI 695501 is interchangeable with the U.S.-marketed formulation of Humira®* 40mg/0.8mL.
- This is the first study in the U.S. to investigate an interchangeability designation for an adalimumab biosimilar candidate. Results are expected in the second half of 2019.
Is
general: Yes
