MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL)
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|ClinicalTrials.gov Identifier: NCT04276740|
Recruitment Status : Not yet recruiting
First Posted : February 19, 2020
Last Update Posted : October 6, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Flare||Dietary Supplement: MitoQ Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC|
|Estimated Study Start Date :||November 1, 2021|
|Estimated Primary Completion Date :||October 2, 2023|
|Estimated Study Completion Date :||October 2, 2023|
Active Comparator: MitoQ
Participants will take oral MitoQ 40 mg daily
Dietary Supplement: MitoQ
MitoQ in inflammation: In the experimental setting, MitoQ has been extensively studied with clear mode of action on inflammatory mechanisms relevant to IBD:
Placebo Comparator: Placebo
Participants will take an oral matched placebo daily
- 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).
- Clinical remission at week 12 [ Time Frame: 12 weeks ]A complete Mayo score of ≤2 points and no individual subscore >1 point.
- Clinical response and remission based on Partial Mayo Score at Week 24 [ Time Frame: 24 weeks ]Defined by a Mayo Clinic score of 2 or less + no subscore >1
- Longitudinal Analysis of Mucosal healing [ Time Frame: 12 weeks ]• Longitudinal Analysis of Mucosal healing - Endoscopic Mayo Score of 0 or 1 at Week 12 and in comparison with baseline Week 0.
- Normalization of faecal calprotectin [ Time Frame: 24 weeks ]Normalization of faecal calprotectin (<250ug/ml) at week 12 and 24 compared to baseline.
- Normalization of faecal haemoglobin [ Time Frame: 24 weeks ]Normalization of faecal haemoglobin (<10 ugHb/ g faeces) at week 12 and 24 compared to baseline.
- Proportions of participants with primary treatment failure with 24 week study period requiring change in medical treatment as below: [ Time Frame: 24 weeks ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04276740
|Contact: Lisa Derr||01316519918 ext firstname.lastname@example.org|
|Contact: Gwo-tzer Ho, MDemail@example.com|
|Principal Investigator:||Gwo-tzer Ho, MD||NHS Lothian|