Allakos Inc. announced positive top-line results for the Xolair-naïve chronic spontaneous urticaria (CSU) cohort from its Phase 2 study. The study is being conducted at 4 sites in the U.S. and Germany. The principle investigator is Dr. Marcus Maurer, MD, Professor of Dermatology and Allergy at Charité University in Berlin. The Xolair-naïve chronic spontaneous urticaria cohort enrolled 13 patients with uncontrolled urticaria despite treatment with H1 antihistamines at doses of up to 4 times the labeled dosage. Antihistamine medication was maintained throughout the screening period and during the study. Baseline symptom scores, as measured by Urticaria Control Test (UCT) and Urticaria Activity Score (UAS7) were collected over a 4-week screening period. Patients with baseline UCT scores of less than 12, indicative of poorly controlled urticaria, were enrolled in the study and treated with up to 6 doses of AK002 given once monthly. Patients received an initial dose of 0.3 mg/kg at baseline, followed by a dose of 1.0 mg/kg on day 28, and then received monthly doses of either 1.0 or 3.0 mg/kg for a total of 6 doses. The primary efficacy endpoint was change from baseline in UCT assessed at week 22, two weeks after the last dose of AK002. AK002 was generally well tolerated. The most common adverse event was mild to moderate infusion-related reactions (flushing, feeling of warmth, headache, nausea, and dizziness) which occurred mostly during the first infusion. Data from the three remaining urticaria cohorts (dermatographic urticaria, cholinergic urticaria, and patients with chronic spontaneous urticaria who failed to respond to treatment with Xolair) are expected in the first quarter of 2019. The open label Phase 2 study is being conducted at 4 sites in the U.S. and Germany. The study enrolled 45 patients with uncontrolled chronic urticaria with a UCT score less than 12 despite treatment with H1 antihistamines at doses up to 4 times the labeled dosage. Patients were enrolled in 4 cohorts depending on the form of urticaria and prior treatment: chronic spontaneous urticaria Xolair naïve (N=13), chronic spontaneous urticaria Xolair failures (N=11), cholinergic urticaria (N=11) and dermatographic urticaria (N=10). Antihistamine medication was maintained throughout the screening period and study. Baseline symptom scores, including UCT, were collected over a 4-week screening period. Patients with baseline UCT scores of less than 12 were enrolled in the study and treated with up to 6 doses of AK002 given monthly. Patients received an initial dose of 0.3 mg/kg, 1.0 mg/kg on day 28, and then received monthly doses of either 1.0 or 3.0 mg/kg for a total of 6 doses. Efficacy was assessed at week 22 using the urticaria control test (UCT) and UAS7 (for patients with chronic spontaneous urticaria only).