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A study to evaluate the safety, tolerability, processing by the body and mechanism of action of RO7486967 in participants with ulcerative colitis
Randomized, double-blind, sponsor-open, phase 1b study to assess the safety, pharmacokinetics and to explore the pharmacodynamics of RO7486967 in patients with moderate to severe active ulcerative colitis
Autoimmune Disorder Inflammatory Bowel Disease (IBD) Ulcerative Colitis
Basic Details
Male and Female
18 to 75 Years
No
Study Identifier
BP43099
Who can participate?
People aged between 18 to 75 years with moderate to severe active ulcerative colitis.
What does the study involve?
Participants will be randomly assigned by a computer program to one group (drug or placebo), i.e. randomized. This means that participants are put into a group by chance (like tossing a coin). Neither a participant nor the study doctor may choose the group to be in. RO7486967 or placebo is provided in gelatin capsules which the participant needs to swallow with a bit of water. A participant will take 3 capsules each day for 7 days consecutively. The total length of time in the study, including the screening, dosing period(s), and follow-up periods, will be approximately 6 weeks. First part involves the study screening which includes discussion of the study, medical history check, physical examination, vital signs check, blood and urine sample collection, measurement of the electrical activity of the heart and pregnancy testing (if female). Then, RO7486967 or placebo is provided in gelatin capsules which one needs to swallow with a bit of water.
What are the possible benefits and risks of participating?
RO7486967 is being given to participants purely for research purposes; it is not intended that one will receive any benefit from it, as the treatment duration of 7 days is too short. New, more effective, and convenient medicines can only be developed by performing research studies such as this one. Information from this study may help doctors learn more about RO7486967 and the treatment of UC. Ultimately, it is the future patients who will hopefully benefit from the results of this study.
Participants may have side effects from the medications or procedures used in this study. However, Roche, the study doctor, and other doctors do not know all of the side effects that could occur. Side effects can vary from mild to very serious and may vary from person to person. Many side effects go away soon after participants stop what is causing them. In some cases, side effects can be serious (in very rare cases may be fatal) and may be long lasting or may never go away. Participants should talk to the study doctor about any side effects that one has have while taking part in the study. Everyone taking part in the study will be watched carefully for any side effects and cared for as appropriate. The study doctors may give medications to help lessen side effects.
Where is the study run from?
Charité Research Organisation GmbH
When is the study starting and how long is it expected to run for?
December 2020 to June 2022
Who is funding the study?
F. Hoffmann-La Roche Ltd (Switzerland)
Who is the main contact?
[email protected]
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
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For the latest version of this information please go to www.forpatients.roche.com