Filgotinib in Phase 2 Trials for Psoriatic Arthritis, Sjogren’s Syndrome and Ankylosing Spondylitis

Filgotinib in Phase 2 Trials for Psoriatic Arthritis, Sjogren’s Syndrome and Ankylosing Spondylitis

Galapagos has initiated three Phase 2 clinical trials to evaluate filgotinib for the treatment of psoriatic arthritis, Sjogren’s syndrome, and ankylosing spondylitis.

According to a press release, in psoriatic arthritis, the therapeutic effectiveness of filgotinib will be evaluated in EQUATOR, a multicenter, double-blind, placebo-controlled Phase 2 clinical trial (NCT03101670).

A total of approximately 124 patients with moderately to severely active disease who have an inadequate response or are intolerant to conventional disease-modifying therapy, will be recruited and randomized to either oral filgotinib tablets ,or matching placebo tablets.

The trial’s primary endpoint is the number of patients achieving at least 20% improvement in the signs and symptoms of psoriatic arthritis at week 16, compared to placebo. This will be assessed by the American College of Rheumatology’s 20 percent improvement score (ACR20).

Secondary endpoints include the effectiveness of filgotinib in improving skin manifestations of psoriasis, as well as other domains like fingers, tendon insertions, spine involvement, and nail involvement.

In Sjögren’s syndrome — a long-term autoimmune disease mainly characterized by the development of a dry mouth and dry eyes —  the clinical effectiveness and safety of filgotinib will be evaluated in a double-blind, placebo-controlled, Phase 2 clinical trial (NCT03100942) which will enroll about 140 adult patients.

Patients will be randomized to treatment with either filgotinib, placebo or two other investigational regimens (GS-9876 and GS-4059) administered once daily for up to 48 weeks. The primary endpoint is the number of patients fulfilling protocol-specified response criteria at Week 12, as compared to baseline.

In ankylosing spondylitis (AS) — a type of arthritis in which there is long-term inflammation of the joints of the spine — the potential therapeutic benefit of filgotinib will be evaluated in TORTUGA. This is a Phase 2 clinical trial in which about 100 patients will be randomized to treatment with either filgotinib (200 mg), or placebo for 12 weeks.

The primary endpoint is the effectiveness of filgotinib in improving the signs and symptoms of AS, compared to placebo. This will be assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12.

Filgotinib is a highly selective JAK1 inhibitor that, in addition to these three new Phase 2 proof-of-concept clinical trials, also isbeing investigated in the ongoing FINCH Phase 3 program in rheumatoid arthritis, as well as in the DIVERSITY Phase 3 trial in Crohn’s disease, and in the SELECTION Phase 2b/3 trial in ulcerative colitis, all initiated in 2016.

Galapagos and Gilead Sciences entered into a global collaboration in 2015, for the development and commercialization of filgotinib in inflammatory indications.

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