Clinical Trials in Crohn’s Disease
Human Paratuberculosis Foundation would like to sponsor innovative human MAP trials in the future. Some research groups have begun trialing therapies that treat human MAP in Crohn’s disease. As the research progresses, HPF will provide information on newly initiated human MAP trials and give updates on the current trial results. The following trials seek to treat human MAP in Crohn’s disease:
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn’s Disease (MAPUS).
Also known as the RedHill study, this Phase III trial of RHB-104 seeks to measure effectiveness and safety in 410 moderate to severe Crohn’s disease adult patient as compared to a placebo. Half of the patients enrolled will be given the active medication, half will receive the placebo. All patients must be taking a concurrent therapy. RHB-104 is a proprietary AMAT combination consisting of 950 mg. of clarithromycin, 450 mg. of rifabutin and 100 mg. clofazimine daily (at the highest dose). It was purchased from Dr. Thomas Borody’s company Giaconda in 2010. The study began in 2013 and the estimated completion date is April 2018. There are a number of inclusion and exclusion criteria, and currently 87 study locations in 7 different countries. RedHill has set up a website for potential participants to learn about the study, which includes an online screener. Patients can find out if they would prequalify for the study, and can choose a doctor’s office where they can get further information about MAP and the RHB-104-01 study information. Please go to MAPmyCrohn’s for more information or to take the online screener.
Open Label Efficacy and Safety of Anti-MAP (Mycobacterium avium spp. paratuberculosis) Therapy in Adult Crohn’s Disease (MAPUS2).
An open-label continuation of the above RedHill blinded study, this separate Phase III study allows Crohn’s disease patients who completed 26 weeks in the above MAPUS study an opportunity to receive RHB-104 for 52 weeks if they have a CDAI of greater than 150 after their initial 26 week trial period. This could yield further long term data on the effectiveness of RHB-104 while giving patients who received the placebo in the above trial an opportunity to take the active medication. The study is currently recruiting and has an estimated completion date of October 2019. 100 adult patients will be enrolled at the study locations listed on ClinicalTrials.gov. Click on the title link for more information.
A Study to Determine the Safety and Immunogenicity of a Candidate MAP Vaccine ChAdOx2 HAV in Healthy Adult Volunteers.
Eagerly anticipated by many in our community, this is the Phase I trial of the Crohn’s MAP vaccine. Initiated in January 2017, the Jenner Institute in Oxford, United Kingdom is recruiting 18 healthy volunteers to test for safety only. (Phase II will begin trials on Crohn’s disease patients.) This step up trial will initially test a lower dose of the vaccine for safety, then progress to intermediate and high doses if there are no adverse reactions. The study completion date is estimated to be April 2018. Click on the title link above for more detailed information.