Trial Results

Celgene announced OTEZLA study Showed Improvements in Patients with Oral Ulcer

February 26, 2018

Celgene announced that data from the Phase III RELIEF clinical trial of OTEZLA(apremilast) in patients with active Behçet’s Disease with oral ulcers showed statistically significant reductions in oral ulcers with apremilast 30mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4). The RELIEF study is a Phase III randomized, placebo-controlled, double-blind study evaluating apremilast 30mg BID in 207 patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication. This 52-week study was conducted at 63 sites across ten countries. In the study, a total of 207 patients were randomized to apremilast 30mg BID or placebo. At week 12, the area under the curve (AUC) for the number of oral ulcers was statistically significantly reduced with apremilast 30mg BID versus placebo (129.5 vs. 222.1; P<0.0001), the trial’s primary endpoint. The most common adverse events observed in the trial were diarrhea (41.3 percent with apremilast, 19.4 percent for placebo), nausea (19.2 percent with apremilast, 10.7 percent for placebo), headache (14.4 percent for apremilast, 9.7 percent for placebo) and upper respiratory tract infection (11.5 percent for apremilast, 4.9 percent for placebo). This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication.

AbbVie Presents New Data on Upadacitinib in Atopic Dermatitis
AbbVie presented new positive results from a Phase II dose-ranging study evaluating upadacitinib, an investigational, once-daily oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis. This dose-ranging study is an ongoing 88-week Phase II, randomized, double-blind, parallel-group, placebo-controlled multicenter study designed to evaluate the safety and efficacy of upadacitinib in adult patients with moderate to severe atopic dermatitis. In Period 1, subjects were randomized in a 1:1:1:1 ratio to one of four treatment for 16 weeks. At week two of treatment with upadacitinib showed all dose groups (30/15/7.5mg once-daily) achieved significant improvement in extent and severity of atopic dermatitis. Secondary endpoints included a proportion of patients achieving EASI 90, EASI 75, an Investigator Global Assessment (IGA) of 0 or 1 and percent change in pruritus/itch numerical rating scale from day one to week 16 in comparison with placebo.

Aimmune Therapeutics announced AR101 met Primary Endpoint for Peanut Allergies
Aimmune Therapeutics announced that its pivotal Phase III PALISADE efficacy trial of AR101 met the primary endpoint. In the United States, AR101 has U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for peanut-allergic patients ages 4–17. PALISADE was an international, randomized 3:1, double-blind, placebo-controlled, Phase III trial of the efficacy and safety of AR101 in a Characterized Oral Desensitization ImmunoTherapy (CODIT) approach in patients with peanut allergy. PALISADE enrolled 499 patients ages 4–17, 496 of whom received treatment. After approximately one year of treatment, patients completed an exit double-blind, placebo-controlled food challenge (DBPCFC). In the primary analysis of 496 patients ages 4–17, 67.2 percent of AR101 patients tolerated a single highest dose of at least 600mg of peanut protein (1043mg cumulative) with no more than mild symptoms in the exit DBPCFC, compared to 4.0 percent of placebo patients. The corresponding difference in response rates was 63.2 percent (p<0.00001, 95 percent CI=53.0–73.3 percent), and, at 53 percent, the lower bound of the 95 percent confidence interval greatly exceeded the pre-specified success criterion, which was 15 percent. Of patients ages 4–17, 296 patients (79.6 percent) from the AR101 arm completed the trial, compared to 116 patients (93.5 percent) from the placebo arm. Of these AR101 completers, 96.3 percent tolerated a single highest dose of at least 300mg (443mg cumulative) of peanut protein in the exit DBPCFC, 84.5 percent tolerated at least 600mg (1043mg cumulative), and 63.2 percent tolerated 1000mg (2043mg cumulative). Additionally, AR101 significantly reduced symptom severity at each exit DBPCFC dose level, compared to placebo.