P144 extension study

• Research type

  Research Study

• Full title

  Open Label Extension (OLE) for the patients treated in the ISD002-P144-07 study with P144 topical administration for skin fibrosis in patients with systemic sclerosis.

• IRAS ID

  4039

• Sponsor organisation

  ISDIN

• Eudract number

  2008-001265-28

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Systemic sclerosis is a generalized disorder of connective tissue of unknown origin. It is characterized clinically by fibrosis of skin, blood vessels and visceral organs, including the gastrointestinal tract, lungs, heart and kidneys. TGF-ß1is one of the principal mediators in the induction of fibrosis and Peptide 144, TGF-ß1-inhibitor, has been specifically designed to block the interaction between this protein and TGF-ß1 type III receptor. The main objective of the study is to assess the long term safety of Disitertide cream topically administered in skin manifestations of systemic sclerosis in terms of the incidence of treatment related adverse events during the treatment. All patients must have previously completed ISD002-P144-07 clinical trial, in which it was compared with placebo on small areas of both forearms. All patients participating in the proposed study will receive P144 once daily for 6 months on up to 10% of their affected skin. It is an open study, there are no comparative treatments. If P144 is effective then patients may experience improvement in their symptoms, but this is not certain. Participating patients will need to attend 5 hospital visits (however, the first of these visits, the baseline visit in the extension protocol, should be combined whenever possible with the third visit of the subject in the previous study (ISD002-P144-07), which will reduce the subject's burden to 4visits). They will have physical examinations at each visit. 1-2 blood samples and a urine sample will be taken on 3 of the visits. Skin tests will be performed on 3 of the visits and a quality-of-life questionnaire will be completed at the same 3 visits (the number of tests / questionnaires may be reduced to 2 if the subject's baseline visit is combined with Visit 3 in the preceding study). Female patients will have pregnancy tests if appropriate. The proposed study is sponsored by the pharmaceutical company ISDIN. Five European countries are involved. Within the UK, the study will be performed at2 locations.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  08/H0502/115

• Date of REC Opinion

  14 Nov 2008

• REC opinion

  Further Information Favourable Opinion