Clinical Trial Resource Center


Clinical Trial Resource Center

New Medical Therapies™

Latest New Medical Therapy Trial Results

Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results are also searchable by therapeutic area beginning with the most recent updates.

Week of November 17, 2014

Amgen and AstraZeneca issued results of a phase III study of brodalumab compared with both Stelara (ustekinumab) and placebo for moderate-to-severe plaque psoriasis. Enrolling more than 1,800 subjects, the pivotal, multi-arm study began with a 12- week, double-blind, active comparator- and placebo-controlled induction phase, in which patients were randomized in a 2:2:1:1 ratio to receive brodalumab (210mg or 140mg), Stelara (per the labeled dose) or placebo. At week 12, patients originally randomized to either brodalumab arm were re-randomized 2:2:2:1 into the maintenance phase to receive brodalumab 210mg or 140mg at four different maintenance regimens. Results showed 36.7% of patients in the brodalumab 210mg group, 27% of patients in the brodalumab 140mg group, 18.5% of patients in the Stelara group and 0.3% of patients in the placebo group achieved total clearance of skin disease (Psoriasis Area Severity Index: PASI 100). In addition, 85.1% of patients in the brodalumab 210mg group, 69.2% of patients in the brodalumab 140mg group, 69.3% of patients in the Stelara group and 6% of patients in the placebo group achieved PASI 75.

Cardiome Pharma released results of a phase III study of Brinavess (vernakalant intravenous, RSD 1235) in the Asia-Pacific (A-P) region in patients with recent-onset atrial fibrillation (AF) lasting three hours to seven days. The study randomized 123 patients. Of the 111 treated patients, 53% of those receiving an IV dose of Brinavess converted to normal heart rhythm within 90 minutes, compared to 12% of placebo patients (95% CI; 23%, 58%, p<0.001). The A-P study data suggested Brinavess generally was well-tolerated in the targeted patient population. In the 30-day interval following drug administration, serious adverse events occurred in six (11%) placebo patients and seven (13%) patients dosed with Brinavess. Potentially drug-related serious adverse events occurred in one (2%) patient receiving Brinavess. There were no cases of drug-related torsades de pointes, a well-characterized arrhythmia that is an occasional side effect of many current antiarrhythmic drugs. The company plans to apply for Brinavess approvals in A-P countries including Taiwan and Korea.

D-Pharm issued results of phase II trials of THR-18 in acute ischemic stroke (AIS) patients treated with tissue plasminogen activator (tPA). This phase III study of THR-18 was the first double-blind, placebo-controlled, escalating single-dose study to assess THR-18 0.18mg/kg or 0.54mg/kg in 30 AIS patients treated with tPA. In contrast to the placebo group, no patients treated with THR-18 had an intracranial hemorrhage (p=0.02). Similarly, THR-18 reduced by more than twice the occurrence of brain edema (p<0.05). These results correlate well with the interim analysis performed on the first treatment groups that completed the 30-day follow-up period. The interim data show THR-18 markedly reduced the degree of disability and enhanced neurological recovery of stroke patients compared to placebo.

Pfizer reported results of a phase IV study of Pristiq Extended Release Tablets 50mg and 100mg doses v. placebo focused on sexual function in adult patients diagnosed with major depressive disorder (MDD). In the phase IV, multi-center, randomized, double-blind placebo-controlled study, a total of 924 patients, 18-years or older, with a baseline HAM-D17 score of ≥20, were randomly assigned to Pristiq 50mg/day, Pristiq 100 mg/ day or placebo in a 1:1:1 ratio over an eight-week period. The primary efficacy end point for the study was the change from baseline in HAM-D17 total score at week eight. Incidence of sexual dysfunction was assessed using the ASEX data. In adult outpatients with MDD with baseline sexual activity and at least one post-baseline assessment, effects on ASEX total and item scores were comparable for the Pristiq 50mg and Pristiq 100mg groups and placebo. Rates of sexual dysfunction were comparable between each Pristiq dose and placebo at baseline (placebo, 52%; Pristiq 50mg/d, 56%; Pristiq 100mg/d, 54%) and at week eight (placebo, 45%; Pristiq 50mg/d, 49%; Pristiq 100mg/d, 47%).