MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis

Launched by UNIVERSITY OF EDINBURGH · Feb 17, 2020

Keywords

ClinConnect Summary

The MARVEL study is exploring a new treatment called MitoQ for people with Ulcerative Colitis (UC) who are experiencing a flare-up. UC is a condition that causes inflammation and ulcers in the large intestine, leading to symptoms like painful diarrhea and fatigue. The goal of this clinical trial is to find out if MitoQ can help reduce inflammation in the gut and improve symptoms for those affected by UC. Participants will take either MitoQ or a placebo (a harmless pill that looks the same but has no active ingredients) for 24 weeks, alongside standard medication. Researchers will check how well the treatment works at 12 and 24 weeks by looking at improvements in symptoms and inflammation levels.

To be eligible for the trial, participants must be at least 18 years old and diagnosed with active UC. They should have certain levels of inflammation indicated by a scoring system used by doctors. People currently on stable doses of specific UC medications may also join, but those with severe forms of UC or certain other health issues won't be included. This study is important because if MitoQ proves effective, it could offer a safer and more affordable treatment option compared to stronger medications that suppress the immune system.

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Eligibility criteria

• • Inclusion Criteria: • Active UC (Mayo of score 6 or greater with endoscopy subscore of 2 or more); or Partial Mayo Score 4-9 (e.g. without the endoscopic score)
• • Baseline rectal bleeding Mayo score of 1 or more
• • ≥18 years old
• • Confirmed diagnosis of UC confirmed on histology and endoscopic evidence for ≥3 months prior to screening.
• • Able to start taking prednisolone at the same time as the study drug/placebo
• • Subjects currently receiving the following treatment for UC are eligible providing they have been on stable dose for designated period of time
• • Oral 5-ASA or sulfasalazine stable dose for at least 4 weeks prior to inclusion and during the study period.
• • Azathioprine, 6-mercaptopurine stable dose for 8 weeks prior to study.
• • Topical treatment (5-ASA or steroid based) for active UC flare including suppository and enema.
• • Able and willing to give informed consent.
• Exclusion Criteria:
• * Severe extensive colitis as evidenced by:
• • Physician judgement that the subject is likely to require hospitalisation for medical care or surgical intervention of any kind for UC (e.g. colectomy) within 12 weeks of baseline.
• • Evidence of fulminant colitis, toxic megacolon or recent history of toxic megacolon within the last 6 months; or bowel perforation.
• • Evidence of acute severe UC fulfilling Truelove and Witts Criteria (\>6 bloody stools/day with evidence of any of these features: tachycardia \[\>90bpm\], fever \[\>37.8C\], anaemia \[Hb \<10.5g/dl\], low albumin \[\<30g/l\]).
• • Any current or previous biologic treatment including anti-TNF therapy or anti-α4β7 therapy; and oral JAK-inhibitors
• • Previous treatment for UC, except those listed in the inclusion criteria.
• • UC confined to proctitis (distal 15 cm or less)
• • UC with Primary Sclerosing Cholangitis (PSC)
• • Diagnosis of Crohn's disease or indeterminate colitis
• • Pregnancy (Current or attempting to become pregnant during trial period) or breastfeeding
• • Cyclosporine, mycophenolate, or tacrolimus administration within 8 weeks of screening.
• • Intravenous corticosteroids for treatment of colitis within 8 weeks of screening
• • Subjects with current - or recent history of - severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic (including uncontrolled hypercholesterolemia), endocrine, pulmonary, cardiac, neurological disease.
• • Subjects who have positive stool examinations for enteric pathogens or Clostridium difficile toxin at screening.
• • Subjects with a known allergy/contraindication to MitoQ.
• • Subjects currently taking any products containing Mitoquinol mesylate (Coenzyme Q10) or any products containing Coenzyme derivatives such as Coenzyme A (CoA, SCoA, CoASH). If subjects are on these products, they can enter the trial after a 7-day washout period.
• • Subjects with current barriers in language or communication that in the judgement of local PI will impede the completion of the trial.
• • A history of overdose or suicide, or significant active mental health problems.