Repeat Doses of HF1020 in Patients with Moderate to Severe Psoriasis

• Research type

  Research Study

• Full title

  Study to Investigate the Safety, Tolerability, Mechanism of Action and Exploratory Clinical Efficacy of Repeat Dose HF1020 in Patients with Moderate to Severe Psoriasis

• IRAS ID

  108583

• Contact name

  Christopher Griffiths

• Sponsor organisation

  Trident Pharmaceuticals Inc

• Eudract number

  2012-002114-39

• Research summary

  Trident Pharmaceuticals, the sponsor, is developing HF1020 for the treatment of inflammatory conditions including psoriasis, asthma and rheumatoid arthritis. In this study, carried out for the company by ICON, a population of psoriatic patients will each receive oral doses of the drug daily over two weeks and the effect on their disease will be evaluated for an extended period after the last dose of the drug. This will help Trident Pharmaceuticals understand how safe the drug is when given in multiple once-a-day doses. In addition, using a number of different techniques, including tissue sampling, the company will gather data in order to better understand how HF1020 works and its potential to reduce the signs and symptoms of psoriasis. Sixteen male psoriatic patients with moderate to severe disease will be enrolled into the study. They will be randomized to receive either HF1020 or placebo aftermscreening; 12 patients will receive HF1020, and 4 will receive placebo. Besides daily visits to the clinic to receive study drug, patients will return to the clinic formsafety tests and disease assessments during the study and two weeks, four weeks, and six weeks afterestopping the study drug. In pre-clinical research HF1020 has demonstrated an ability to down regulate the inflammatory response that is at the heart of not only psoriasis but also asthma, rheumatoid arthritis and inflammatory bowel disease. Treatment of patients with psoriasis remains problematic as few drugs have any lasting effect on the progression of the disease. Positive results from this trial would representan early demonstrate that HF1020 has the potential to provide long term benefit to patients with psoriasis and related inflammatory conditions.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0459

• Date of REC Opinion

  15 Aug 2012

• REC opinion

  Further Information Favourable Opinion