A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: GWP42003; Placebo
Intervention description: 1 to 5 50 mg capsules taken BID; 1 to 5 matching capsules taken BID
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mild to Moderate Ulcerative Colitis; GWP42003

Summary:

      This study was conducted to determine the efficacy and safety of GWP42003 compared with
      placebo by the percentage of participants achieving remission quantified as a Mayo score of 2
      or less (with no sub-score >1) after 10 weeks of treatment.
    

Eligibility criteria:

        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-Aminosalicylic (5-ASA) treatment and have been on a stable dose for at least 2 weeks
             prior to screening (0 mg dose of 5-ASA was acceptable);

          -  Participants at screening and baseline 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 for his or her name to be notified to the responsible authorities for
             participation in this study, as applicable;

          -  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 (proctitis)

          -  Gastrointestinal infection evident from stool culture and testing for Clostridium
             difficile toxin (in the opinion of the investigator);

          -  Currently using or had used recreational cannabis, medicinal cannabis, cannabinoid
             medications (including Sativex®), or synthetic cannabinoid-based medications within 1
             month prior to study entry and unwilling to abstain for the duration of the study;

          -  Any known or suspected history of alcohol or substance abuse, epilepsy or recurrent
             seizures, or hypersensitivity to cannabinoids;

          -  Was receiving a prohibited medication prior to screening and for the duration of the
             study;

          -  Previous non-responders to mono or polyclonal anti-Tumor Necrosis Factor antibodies;

          -  Personal or first degree relative, with history of schizophrenia or other psychosis;

          -  History of other significant psychiatric disorder or severe personality disorder (at
             the discretion of the investigator);

          -  Any known or suspected history of depression sufficient to require treatment with
             antidepressants or disrupt ordinary life (excluding episodes of reactive depression at
             the discretion of the investigator);

          -  Clinically significant cardiac, renal or hepatic impairment in the opinion of the
             investigator;

          -  Female participants who were 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 2 forms of
             contraception, 1 of which must have been a barrier contraception (for example, a
             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 have been used in conjunction with the female condom);

          -  Male participants whose partner was 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 (for example, an
             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 have been used
             in conjunction with a female condom);

          -  Planned to travel outside the country of residence 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, was not considered to be suitable for the study;

          -  Any other significant disease or disorder which, in the opinion of the investigator,
             may either have put the participant at risk because of participation in the study, or
             may have influenced the result of the study or the participant's ability to
             participate in the study;

          -  Participant with 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 randomized into this study.