Multicentre Phase III SU study, Final Version 1.0, 22 October 2009

• Research type

  Research Study

• Full title

  A Phase III, Multicentre, Double–Blind, Placebo Controlled, Crossover Study to Evaluate the Safety and Efficacy of Subcutaneous Bioresorbable Implants of Afamelanotide in the Treatment of Solar Urticaria (SU.

• IRAS ID

  32308

• Contact name

  Lesley Rhodes

• Sponsor organisation

  Clinuvel Pharmaceuticals Limited

• Eudract number

  2008-002143-16

• Research summary

  This is a multicentre, double-blind study in subjects with solar urticaria confirmed by photoprovocation to produce a wheal (oedema) and flare (diffuse erythema). A measurement of baseline MUD by provocation will be determined using an artificial light source emitting wavelengths across ultraviolet A, ultraviolet B and into the visible spectrum. Subjects will be randomized in equal numbers to one of two treatment groups and will receive either afamelanotide (16mg implants) or placebo on Day 0 followed by the alternate treatment on Day 90. - Group A will receive an afamelanotide implant on Day 0 and placebo implant on Day 90. - Group B will receive a placebo implant on Day 0 and an afamelanotide implant on Day 90. The MUD will be determined on the skin surface of the participant's mid-back or buttocks at Screening, Day 30, Day 90 and Day 120. Melanin density levels will be measured at each of these timepoints. A photograph of the entire phototested area will be taken after MUD has been determined. The number of naturally occurring urticarial reactions, along with the participant's sun exposure behaviour will be documented. As part of the documentation, a paper diary will be completed daily by the subject for their duration in the study to investigate sun exposure while outdoors. The diary uses the word 'outdoors', which equates to time exposed to the sun. A diary review will be conducted monthly to ensure compliance. Two quality of life questionnaires (DLQI and Skindex-29) will be completed at the site during the clinic visit at Screening, Day 30, 90 and 120. Safety and concomitant medication will be assessed at every clinic visit except Screening for the duration of the study.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/140

• Date of REC Opinion

  4 Feb 2010

• REC opinion

  Further Information Favourable Opinion