MitoQ treatment for inflammation in ulcerative colitis

Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC

This study is testing if a new antioxidant called MitoQ can help reduce inflammation and improve symptoms in people with active ulcerative colitis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Edinburgh (Academic / other)
• Locations: 1 site (Edinburgh)
• Trial ID: NCT04276740 on ClinicalTrials.gov

What this trial studies

This Phase 2b clinical trial investigates the efficacy of MitoQ, a mitochondrial antioxidant, in treating active ulcerative colitis (UC) over a 24-week period. The study is multi-centered and randomized, comparing MitoQ to a placebo to assess its impact on inflammation and symptoms associated with UC. Participants must have a confirmed diagnosis of UC and meet specific eligibility criteria, including certain Mayo score thresholds. The trial aims to determine if MitoQ can reduce inflammation by targeting mitochondrial dysfunction in the gut.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with active ulcerative colitis and specific Mayo score criteria.

Not a fit: Patients with severe extensive colitis or those unable to provide informed consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis and enhance patients' quality of life.

How similar studies have performed: Previous studies have indicated that targeting mitochondrial dysfunction may be a promising approach, but this specific application of MitoQ in UC is novel.

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.

Where this trial is running

Edinburgh

• NHS Lothian — Edinburgh, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Gwo-tzer Ho, MD — NHS Lothian
• Study coordinator: Lisa Derr

Conditions Ulcerative Colitis Flare