A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)

Inclusion Criteria:

• Male or female participants aged 18 years or above;
• Participant diagnosed with mild to moderate ulcerative colitis and on a fixed dose of 5-ASA treatment and have been on a stable dose for at least 2 weeks prior to screening;
• Participants at screening (Visit 1) and baseline (Visit 2) with a MAYO assessment score of greater than or equal to 4 (≥ 4) but less than or equal to 10 (≤ 10) and with an endoscopy score of at least 1 (≥ 1) , following an adequate exposure to oral and/ or topical 5-ASA, in the opinion of the investigator;
• In the opinion of the investigator, capable of complying with the study requirements and completing the study;
• Willing and able to give informed consent;
• Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study;

Exclusion Criteria:

• Severe ulcerative colitis (MAYO score of greater than 10 (> 10));
• Ulcerative colitis only affecting the rectum i.e. Proctitis
• Gastrointestinal infection evident from stool culture and testing for clostridium difficile toxin (in the opinion of the investigator);
• Previous non-responders to mono or polyclonal anti-Tumour Necrosis Factor antibodies;
• Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for 3 months from the date of last dose;
• Female participants of child bearing potential, unless willing to use two forms of contraception, one of which must be a barrier contraception (e.g. female condom or occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months from the date of last dose (however a male condom should not be used in conjunction with the female condom);
• Male participants whose partner is of child bearing potential, unless willing to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (e.g. occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months from date of last dose (however a male condom should not be used in conjunction with a female condom);
• Travel outside the country of residence planned during the treatment phase of the study;
• Received an Investigational Medicinal Product (IMP) within 30 days prior to the screening visit;
• In the opinion of the investigator, is not considered to be suitable for the study;
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, may influence the result of the study, or the participant's ability to participate in the study;
• Following a physical examination, the participant has any abnormalities that, in the opinion of the investigator would prevent the participant from safe participation in the study;
• Unwilling to abstain from donation of blood during the study;
• Participants previously randomised into this study.