Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Product Code: GWP42003
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Not applicable
CAS Number: 13956-29-1
Current Sponsor cod
Sponsors
GW Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion 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-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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 57 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Severe ulcerative colitis (MAYO score of greater than 10 (>10)). • Ulcerative colitis only affecting the rectum i.e. Proctitis • Infection evident from stool culture and testing for clostridium difficile toxin (in the opinion of the investigator); • Currently using or has used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid based medications within one 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 - hypersensitivity to cannabinoids • Receiving a prohibited medication according to the protocol prior to screening and for the duration of the study; • Previous non-responders to mono or polyclonal anti-Tumour Necrosis Factor antibodies; • Personal or first degree relative, with history of schizophrenia, other psychotic illness, severe personality disorder, or other significant psychiatric disorder; • 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 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 participant 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 subject 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; • Previously randomised into this
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of GWP42003 compared with placebo by the percentage of participants achieving remission quantified as a MAYO score of 2 or less (with no subscore>1) after 10 weeks treatment.; Secondary Objective: To evaluate the efficacy of GWP42003 compared with placebo on: • C-reactive protein (CRP) • Plasma levels of inflammatory cytokines • Faecal inflammatory markers • Inflammatory Bowel Disease Questionnaire (IBDQ) • Subject’s global impression of change (SGIC) • Physician’s global assessment of illness severity (PGAS) • Stool frequency (NRS scale) • Rectal bleeding (NRS scale) • Pain Score (NRS scale) • Endocannabinoid plasma levels as an exploratory endpoint (where required storage facilities allow) • MAYO score • Responder analysis defined as participants at the end of treatment with a decrease in their MAYO score of =3 compared to baseline (with a reduction of at least 1 in endoscopic subscore). • Body weight To assess the safety and tolerability of GWP42003 compared with placebo. ;Primary end point(s): The primary efficacy endpoint will be the percentage of subjects at the end of treatment achieving remission quantified as a MAYO score of 2 or less (with no subscore>1) after 10 weeks treatment.;Timepoint(s) of evaluation of this end point: 10 weeks post treatment (with potential added time to allow for visit windows) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: • CRP • Plasma Il-2, Il-6, TNFa • Faecal calprotectin • IBDQ • SGIC • PGAS • Stool frequency (NRS scale) • Rectal bleeding (NRS scale) • Pain Score (NRS scale) • Endocannabinoid plasma levels as an exploratory endpoint (where required storage facilities allow) • MAYO score • Number of subjects at the end of treatment with a decrease in their MAYO score of 3 or more compared to baseline (with a reduction of at least 1 in endoscopic subscore) • Body Weight Secondary Safety Endpoints: • To assess the safety and tolerability of GWP42003 compared with placebo in terms of the incidence, type and severity of AEs, and changes in vital signs, ECG, laboratory and physical examination parameters. ;Timepoint(s) of evaluation of this end point: 10 weeks post treatment (with potential added time to allow for visit windows) | — |
Countries
Czech Republic, United Kingdom
Contacts
Public ContactGW Pharma Ltd. Switchboard
GW Pharma Ltd.
Outcome results
None listed