Two novel autoimmune therapies have progressed into Phase III clinical development according to recent US trial registry postings. Bristol Myers Squibb (BMS) has commenced the Breakfree-SSc study, a randomised, open-label trial evaluating its CD19 CAR-T therapy, zolacaptagene autoleucel, against standard treatments in 92 patients with active systemic sclerosis (SSc). The primary endpoint is the absolute change in forced vital capacity (FVC) at 12 months. This follows promising Phase I data which showed an unprecedented 10% median improvement in predicted FVC at six months in patients with SSc-related interstitial lung disease.

Separately, Merck KGaA has initiated the Phase III Elowen-1 trial for enpatoran, an oral TLR7/8 inhibitor, in patients with lupus and active skin symptoms. The global, randomised, double-blind study aims to assess the proportion of patients achieving a CLASI 70 response. While earlier Phase II studies showed positive trends, the therapy did not meet the primary endpoint for a dose-response relationship. Both trials represent significant steps in developing new treatment modalities for complex autoimmune conditions.

PharmCube's TrialiCube™ database lists 127 Phase III immunology trials set to commence, with China accounting for the largest number. Click here to request a free trial for TrialiCube™.