This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee.

After a screening period of up to 3 weeks and radiographic evaluation of the target knee joint space, 225 subjects will be randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group (i.e., 2 subjects to active treatment and 1 subject to placebo):

Group A: 8.75 mg X0002/knee (2 sprays/knee, one spray to the medial surface and one spray to the lateral surface of the knee), twice daily (BID, approximately every 12 hours; n=50) or placebo (2 sprays/knee), BID (approximately every 12 hours; n=25) for a total of 4 sprays per knee per day; Group B: 17.5 mg X0002/knee (4 sprays/knee, one spray to the medial surface and one spray to the lateral surface of the knee, and one spray to front and one spray to the back of the knee), BID (approximately every 12 hours; n=50) or placebo (4 sprays/knee), BID (approximately every 12 hours; n=25) for a total of 8 sprays per knee per day; Group C: 35 mg X0002/knee (8 sprays/knee, each spray is to be applied to a different non-overlapping area around the knee, and the areas are to be uniformly distributed around the knee), BID (approximately every 12 hours; n=50) or placebo (8 sprays/knee), BID (approximately every 12 hours; n=25) for a total of 16 sprays per knee per day.

Safety and efficacy assessments will be performed at at 2, 4, 8, and 12 weeks of treatment.

Read more: http://www.clinicaltrials.gov/ct2/show/NCT02067611?cond=%22Arthritis%22&lup_s=01/29/2014&lup_d=30