Clinical Trials

Date: 2017-01-10

Type of information: Results

phase: 3

Announcement:

Company: Coherus Biosciences (USA - CA)

Product: CHS-1420 (biosimilar version of Humira® (adalimumab))

Action mechanism: monoclonal antibody/biosimilar product/TNF alpha inhibitor. CHS-1420 is a biosimilar version of the monoclonal antibody adalimumab (Humira®). Adalimumab specifically binds to tumor necrosis factor (TNF)-alpha. Samsung Bioepis has initiated a phase 3 study in psoriasis in 2015.

Disease: plaque psoriasis

Therapeutic area: Autoimmune diseases - Dermatological diseases

Country: USA

Trial details: This is a 3-part study comparing CHS-1420 to Humira® in patients with chronic plaque psoriasis. (NCT02489227)

Latest news:

• • On January 10, 2017,  Coherus BioSciences reported results from an ongoing 3-Part, Phase 3 clinical study of CHS-1420, an adalimumab biosimilar candidate. As previously reported, this study met its primary endpoint demonstrating similarity between CHS-1420 and Humira® with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at week 12. The 95% confidence intervals for the difference between treatment groups fell well within the pre-specified margin.
• Results from Part 2 of the study focused on maintenance of response through Week 24. At the start of Part 2 (Week 16), 80.3% of subjects in the CHS-1420 group and 77.5% of subjects in the Humira® group achieved PASI-75. In Part 2 (weeks 16-24), half of the subjects who were initially treated with Humira® were switched to CHS-1420, modeling a chronic patient’s transition to a biosimilar. In Part 2, maintenance of PASI-75 was similar across the 3 subsequent treatment groups: CHS-1420 followed by CHS-1420, Humira® followed by CHS-1420, and HUMIRA followed by Humira®. CHS-1420 and Humira® were similarly well tolerated in all groups during Part 2. Anti-drug antibody results are preliminary at this time, but have not identified any clinically significant differences between the treatment groups.
• This is a confirmatory, randomized, double-blind, active-control, parallel-group, 3-part study in patients with active, moderate to severe, chronic plaque psoriasis. In Part 3, all subjects receive CHS-1420 for an additional 24 weeks. Data from this study will be presented at an upcoming scientific conference. Cohrerus Biosciences currently anticipates filing the Biologic License Application (BLA) submission in the first half of 2017.

 

Is general: Yes