Ulcerative Colitis FlarePhase 2MARVELNCT04276740
MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis
A Phase 2 study testing MitoQ in people with Ulcerative Colitis Flare, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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 inner lining of the rectum and colon (the large bowel). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis Flare
- What is being tested?
- MitoQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 31 May 2022to 30 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC
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 inner lining of the rectum and colon (the large bowel). In UC, ulcers develop on the surface of the lining and these may bleed and produce mucus. Individuals with UC can become very unwell with disabling bloody diarrhoea, uncontrollable bowel habit and profound tiredness. In very severe cases, UC carry the risks of rupture of the inflamed bowel wall requiring an emergency operation to remove the colon.
Read more
The MARVEL study investigates whether MitoQ is a beneficial drug treatment for UC.
Earlier studies have shown that the inflamed UC gut lining releases 'danger signals' arising from the mitochondria. These 'danger signals' attract immune cells and make inflammation worse.
Mitochondria are the 'batteries' or 'power stations' that reside within, and provide energy for living cells. In the gut lining of individuals with UC, the mitochondria are more prone to damage that increases the release of these danger signals.
MitoQ protects the mitochondria and exerts an anti-inflammatory effect. The investigators hypothesise that MitoQ will improve UC and allow the bowels to heal properly following a disease flare.
In the MARVEL study, individuals with an active flare of UC requiring standard oral Prednisolone will be given either MitoQ or placebo as a daily capsule for 24 weeks.
The Investigators will carry out an assessment after 12 and 24 weeks to find out if MitoQ will result in higher rates of improvement in the participants' symptoms and gut lining inflammation. Furthermore, the investigators will investigate if their UC will be better controlled and that they are less likely to need further steroids or more potent forms of drugs.
MitoQ has been shown to be safe in 2 large human clinical studies in Parkinson's disease and Hepatitis C, but the MARVEL study will be the first study in UC. At low doses, MitoQ is used as a nutritional supplement that has an anti-oxidant effect.
Currently, many drug treatments in UC are very strong, expensive and aimed at suppressing the immune system. If the MARVEL study provides supportive data, MitoQ can be a safe and cost-effective new treatment that works at blocking the specific inflammatory signal found in the gut lining of individuals with UC.
- Conditions
- Ulcerative Colitis Flare
- Being tested
- MitoQ, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQDietary supplement
MitoQ in inflammation: In the experimental setting, MitoQ has been extensively studied with clear mode of action on inflammatory mechanisms relevant to IBD:
- MitoQ can limit the damage to mitochondria caused by mitochondrial ROS and thereby reducing the leak and oxidisation of mtDNA that are critical to its pro-inflammatory actions within the cell.
- MitoQ reduces the inflammatory potential of mitochondrial DNA which have escaped or released from dying inflammatory cells.
- MitoQ can influence how the immune cells generate their energy, diverting it away from a more inflammatory type of metabolism (glycolysis)
- MitoQ can induce autophagy, a cellular recycling mechanism that removes damaged mitochondria. Defective autophagy is heavily implicated in the pathogenesis of IBD.
- Hence collectively, MitoQ acts upstream of several pro-inflammatory mechanisms with the net effect to promote resolution of inflammation and mucosal healing.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MitoQ | Active comparator | Participants will take oral MitoQ 40 mg daily Receives: Dietary Supplement: MitoQ |
| Placebo | Placebo comparator | Participants will take an oral matched placebo daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of subjects achieving clinical response at Week12
Defined by a decrease from baseline of Mayo Score of at least 3 points and at least 30%, with accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of rectal bleeding of 0 or 1.
treatment in ulcerative colitis (UC).
Measured: 12 weeks
Secondary outcomes (6)
Clinical remission at week 12
A complete Mayo score of ≤2 points and no individual subscore >1 point.
Measured: 12 weeks
Clinical response and remission based on Partial Mayo Score at Week 24
Defined by a Mayo Clinic score of 2 or less + no subscore >1
Measured: 24 weeks
Longitudinal Analysis of Mucosal healing
- Longitudinal Analysis of Mucosal healing - Endoscopic Mayo Score of 0 or 1 at Week 12 and in comparison with baseline Week 0.
Measured: 12 weeks
Normalization of faecal calprotectin
Normalization of faecal calprotectin (<250ug/ml) at week 12 and 24 compared to baseline.
Measured: 24 weeks
Normalization of faecal haemoglobin
Normalization of faecal haemoglobin (<10 ugHb/ g faeces) at week 12 and 24 compared to baseline.
Measured: 24 weeks
Proportions of participants with primary treatment failure with 24 week study period requiring change in medical treatment as below:
- Re-treatment with oral or intravenous corticosteroids
- Inability to wean off steroids, requiring further increase of Prednisolone during weaning stage due to flare symptoms
- Biologics (anti-TNF, anti-α4β7, anti-IL23 or Jak-inhibitors)
- Azathioprine or 6-mercaptopurine in participants who are currently not on a thiopurines
- Oral or intravenous ciclosporin
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start31 May 2022
- Primary completion14 Dec 2025
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis FlareStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- JP Moulton Charitable Foundation, MitoQ
- Responsible party
- Sponsor
- Investigators
- David Wilson, MD, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276740
- Sponsor's protocol ID
- AC19100
- Acronym
- MARVEL
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2020
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC
- ClinicalTrials.gov ID
- NCT04276740
- Acronym / sponsor ID
- MARVEL / AC19100
- Conditions
- Ulcerative Colitis Flare
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- JP Moulton Charitable Foundation, MitoQ
- Study start
- 31 May 2022 (actual)
- Primary completion
- 14 Dec 2025 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 inner lining of the rectum and colon (the large bowel). In UC, ulcers develop on the surface of the lining and these may bleed and produce mucus. Individuals with UC can become very unwell with disabling bloody diarrhoea, uncontrollable bowel habit and profound tiredness. In very severe cases, UC carry the risks of rupture of the inflamed bowel wall requiring an emergency operation to remove the colon.
The MARVEL study investigates whether MitoQ is a beneficial drug treatment for UC.
Earlier studies have shown that the inflamed UC gut lining releases 'danger signals' arising from the mitochondria. These 'danger signals' attract immune cells and make inflammation worse.
Mitochondria are the 'batteries' or 'power stations' that reside within, and provide energy for living cells. In the gut lining of individuals with UC, the mitochondria are more prone to damage that increases the release of these danger signals.
MitoQ protects the mitochondria and exerts an anti-inflammatory effect. The investigators hypothesise that MitoQ will improve UC and allow the bowels to heal properly following a disease flare.
In the MARVEL study, individuals with an active flare of UC requiring standard oral Prednisolone will be given either MitoQ or placebo as a daily capsule for 24 weeks.
The Investigators will carry out an assessment after 12 and 24 weeks to find out if MitoQ will result in higher rates of improvement in the participants' symptoms and gut lining inflammation. Furthermore, the investigators will investigate if their UC will be better controlled and that they are less likely to need further steroids or more potent forms of drugs.
MitoQ has been shown to be safe in 2 large human clinical studies in Parkinson's disease and Hepatitis C, but the MARVEL study will be the first study in UC. At low doses, MitoQ is used as a nutritional supplement that has an anti-oxidant effect.
Currently, many drug treatments in UC are very strong, expensive and aimed at suppressing the immune system. If the MARVEL study provides supportive data, MitoQ can be a safe and cost-effective new treatment that works at blocking the specific inflammatory signal found in the gut lining of individuals with UC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitoQ | Active comparator | Dietary Supplement: MitoQParticipants will take oral MitoQ 40 mg daily |
| Placebo | Placebo comparator | Other: PlaceboParticipants will take an oral matched placebo daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Severe extensive colitis as evidenced by:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoQMitoQ in inflammation: In the experimental setting, MitoQ has been extensively studied with clear mode of action on inflammatory mechanisms relevant to IBD: * MitoQ can limit the damage to mitochondria caused by mitochondrial ROS and thereby reducing the leak and oxidisation of mtDNA that are critical to its pro-inflammatory actions within the cell. * MitoQ reduces the inflammatory potential of mitochondrial DNA which have escaped or released from dying inflammatory cells. * MitoQ can influence how the immune cells generate their energy, diverting it away from a more inflammatory type of metabolism (glycolysis) * MitoQ can induce autophagy, a cellular recycling mechanism that removes damaged mitochondria. Defective autophagy is heavily implicated in the pathogenesis of IBD. * Hence collectively, MitoQ acts upstream of several pro-inflammatory mechanisms with the net effect to promote resolution of inflammation and mucosal healing. | Dietary supplement | MitoQ |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
The proportions of subjects achieving clinical response at Week12
Time frame: 12 weeks
Defined by a decrease from baseline of Mayo Score of at least 3 points and at least 30%, with accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore of rectal bleeding of 0 or 1. treatment in ulcerative colitis (UC).
6 secondary outcomes
Clinical remission at week 12
Time frame: 12 weeks
Clinical response and remission based on Partial Mayo Score at Week 24
Time frame: 24 weeks
Longitudinal Analysis of Mucosal healing
Time frame: 12 weeks
Normalization of faecal calprotectin
Time frame: 24 weeks
Normalization of faecal haemoglobin
Time frame: 24 weeks
Proportions of participants with primary treatment failure with 24 week study period requiring change in medical treatment as below:
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wilson, MD principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MitoQ in people with Ulcerative Colitis Flare, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportions of subjects achieving clinical response at Week12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.