Phase IIa Study to Investigate the Biological Activity of Oral FX125L

• Research type

  Research Study

• Full title

  An Exploratory Phase IIa Study to Investigate the Biological Activity of Oral FX125L in Adult Patients with Chronic Inflammatory Disease

• IRAS ID

  92623

• Contact name

  Jorg Taubel

• Sponsor organisation

  Funxional Therapeutics Ltd.

• Eudract number

  2011-005036-26

• ISRCTN Number

  n/a

• Research summary

  We are conducting a clinical trial with a new experimental drug called FX125L in up to 119 volunteers with chronic inflammation diseases such as asthma, chronic obstructive pulmonary disease (COPD), rheumatoid arthritis (RA) and psoriasis to find out more information about the safety of the drug and explore how the drug works; to enable us to carry out further research on a larger number of patients. The study design will be double-blinded, randomized and placebo-controlled which means patients will receive either FX125L or placebo (dummy drug) and neither the doctor or the patient will know whether each patient has taken the drug or placebo. The study will be conducted at a single centre and will last approximately 17 weeks including the time when we determine who is suitable for taking part in the study, and the follow-up at the end of the study. Patients will attend our unit for 6 visits in total and will be treated for 56 days, mainly at home. The main clinical assessments will include blood tests to make sure it is safe to give volunteers the drug, to assess how the drug is handled by the body and to measure specific markers which give us information on how the drug is working. Volunteers will also be asked to complete a questionnaire about themselves and will have to fill out a diary during the treatment to confirm they have taken the medicine and note any side effects they may experience. Patients with chronic inflammatory diseases often experience pain, fatigue, digestive problems, and other symptoms caused by the inflammation and side effects from the drugs they have to take so there is an unmet need for new medicines.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/1747

• Date of REC Opinion

  25 Nov 2011

• REC opinion

  Further Information Favourable Opinion