Galapagos announces start of Phase 2 study with selective TYK2 inhibitor, GLPG3667, in patients with active systemic lupus erythematosus

The GALACELA Phase 2 trial (NCT05856448) is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3667 in adults with active SLE. A once-daily oral administration of GLPG3667 or placebo will be investigated in approximately 140 adult patients with SLE for 32 weeks. The primary endpoint is the proportion of patients who achieve the SLE responder index (SRI)-4 response at Week 32. The secondary efficacy endpoints are the proportion of patients who achieve the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 32, proportion of patients with >=50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score at Week 16, proportion of patients who achieve Lupus Low Disease Activity State (LLDAS) at Week 32 and change from baseline in the 28-joint count for tender, swollen, and tender and swollen (active) joints at Week 32.

“We are proud to have reached this important milestone in our journey to improve the lives of patients living with autoimmune diseases. Although significant progress has been made in the management of SLE over the past decade, flares, morbidity, and mortality continue to remain a significant concern and quality of life is poor among patients living with SLE,” said Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head Immunology, at Galapagos. “We are excited about GLPG3667’s potential to make a meaningful difference for people living with SLE and look forward to advancing this candidate medicine in clinical development.”

GLPG3667 is an investigational drug and is not approved by any regulatory authority. Its efficacy and safety have not been established or fully evaluated by any regulatory authority.