Status:
RECRUITING
MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
JP Moulton Charitable Foundation
MitoQ
Conditions:
Ulcerative Colitis Flare
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2b, multi-centered, randomized, placebo-controlled trial with treatment phase over 24 weeks. Ulcerative Colitis (UC) is a condition that causes inflammation and ulceration of the inne...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04276740
Start Date
May 31 2022
End Date
December 31 2025
Last Update
December 5 2024
Active Locations (1)
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1
NHS Lothian
Edinburgh, United Kingdom