Galapagos and Gilead Plan Phase 2 Trial of Filgotinib for Skin Lupus

Galapagos will collaborate with Gilead on a Phase 2 trial evaluating the effectiveness and safety of filgotinib as a treatment for the skin disease cutaneous lupus erythematosus (CLE).

Lupus is an autoimmune disease affecting many systems and organs, which means many symptoms are associated with it.

CLE is a skin lupus that can be triggered or worsened by exposure to sunlight. It is most often found in women 20-50 years, although it can occur at any age. About a third of women with CLE also develop systemic lupus erythematosus (SLE).

Filgotinib is a Jak-1 inhibitor. Jak-1, or Janus kinase 1, is a naturally occurring protein that takes part in a chain of events leading to inflammation.  That propensity has prompted researchers to test Jak-1 inhibitors as a treatment for many autoimmune disorders. These disorders, caused by injury or damage to the immune system, lead to abnormal inflammation.

The trial will be a Phase 2 proof-of-concept study. It will look at the drug’s safety and establish the dose that’s required for it to have an impact on the disease. It will be a multi-center, randomized, double-blind, placebo-controlled study in women with CLE.

The 50 patients will come from 18 centers in the United States and Canada. Some patients will receive filgotinib, some another drug, and a control group a placebo.

Researchers will measure the success of the treatment by comparing patients’ disease at the beginning of the trial and after 12 weeks.

The yardstick will be patients’ Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores. The index measures CLE damage and the level of the disease’s activity.

“We are very excited with the initiation of this Proof-of-Concept study with filgotinib in CLE. This is the first time we will evaluate filgotinib in an autoimmune skin disorder, and specifically, one with a significant unmet need,” Walid Abi-Saab, Galapagos’ chief medical officer, said in a press release. “This study represents another cornerstone in Gilead and Galapagos’ efforts to explore filgotinib in inflammation. We look forward to seeing whether filgotinib can impact signs and symptoms of CLE.”

Galapagos is a biotechnology company specializing in the discovery and development of small molecules with novel modes of action. Gilead is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.