A Phase 2 clinical trial testing the efficacy and safety of three investigational therapies — filgotinib, GS-9876, and tirabrutinib — in adults with active Sjögren’s syndrome is recruiting participants.
The study (NCT03100942) is being conducted by Gilead Sciences, in collaboration with Galapagos. It is expected to enroll 140 patients with active Sjögren’s syndrome at 60 centers across the U.S., Spain and the U.K.
Additional sites, possibly in other countries, are expected to open. Enrollment information is available by clicking on the trial’s identification number.
Participants will be randomly assigned one of three treatments — filgotinib (Galapagos), GS-9876 (Gilead) or tirabrutinib (Ono Pharmaceutical/Gilead) — given orally once a day for up to 48 weeks.
A fourth group will receive placebo for 24 weeks, after which participants will be re-randomized to one of the three active treatments that will be given through week 48.
The trial’s primary endpoint is the proportion of patients who responded to the treatment at week 12. Response is defined as a combined improvement in biologic and patient-reported outcomes.
Additional, or secondary, study goals include changes in disease activity, measured using the European League Against Rheumatism (EULAR) Sjogren’s Syndrome disease activity index (ESSDAI), and changes in patient symptoms like dryness, pain, and fatigue — assessed with the EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI).
Filgotinib is a highly selective inhibitor of the Janus kinase 1 (JAK1), a key factor in certain immune responses. The investigational drug has been tested as a potential therapy for inflammatory conditions, including rheumatoid arthritis, Crohn’s disease and ulcerative colitis (UC). The new trial will determine filgotinib’s efficacy in Sjögren patients.
GS-9876 is an inhibitor of the spleen tyrosine kinase or Syk, an important modulator of immune signalling. Gilead is developing GS-9876 as a therapy for inflammatory conditions like rheumatoid arthritis, cutaneous lupus erythematosus, and Sjogren’s syndrome.
Tirabrutinib is a potent and orally active inhibitor of the Bruton tyrosine kinase (BTK) found on certain immune cells, called B-cells. B-cells are tightly involved in inflammatory processes and blocking their development by targeting BTK is thought to ease inflammation in auto-immune diseases.
In December 2015, Galapagos formed a global collaboration with Gilead allowing it to develop and commercialize filgotinib for the treatment of inflammatory indications.
“We look forward to seeing the study results which will show whether filgotinib can impact signs and symptoms [of Sjogren’s syndrome patients],” Dr. Walid Abi-Saab, chief medical officer of Galapagos, said in a press release.
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