A Phase 1, drug-drug interaction trial of IMU-838 with oral contraceptives in women
This Phase 1 clinical trial investigates how an experimental medication for multiple sclerosis (MS), known as IMU-838, interacts with standard birth control pills. Many women diagnosed with MS are of childbearing age and rely on oral contraceptives for family planning. When two different medicines are taken at the same time, they can sometimes change how each other is absorbed or broken down by the body. This study aims to check whether IMU-838 alters the levels of contraceptive hormones in the bloodstream, which could make the pill less effective, or if the pill changes the way IMU-838 works. Participants in this trial are adult women who will take the treatments under close medical monitoring. The goal is to collect vital safety information so doctors can safely guide women with MS who need reliable contraception in the future.
At a glance
What is this study about?
Multiple sclerosis (MS) is a long-term condition affecting the brain and spinal cord, which can cause problems with vision, balance, and muscle movement. Many people diagnosed with MS are young adult women. Finding effective, easy-to-take treatments is essential, and scientists are currently testing a new daily tablet called IMU-838.
Because many women take the contraceptive pill, doctors must confirm whether taking IMU-838 at the same time affects how well birth control works. In some cases, one medication can speed up or slow down how the body processes another. If IMU-838 were to lower the hormone levels provided by the pill, it could increase the risk of an unplanned pregnancy.
This study is known as a 'drug-drug interaction' trial. It is designed to measure the levels of both medications in the blood to ensure they do not interfere with each other. By monitoring participants carefully, the researchers can see exactly how the body handles both treatments when they are taken together.
While this trial does not test how well IMU-838 treats MS symptoms, it provides crucial safety information. Understanding how the drug interacts with common medications helps ensure that future treatments are safe and practical for women in everyday life.
Key takeaways
- Tests how a potential MS tablet (IMU-838) interacts with oral contraceptive pills.
- Open to adult women aged 18 and older.
- Helps make sure future MS treatments do not reduce the effectiveness of birth control.
- Requires clinic visits for regular blood tests and health checks.
- Participation is completely voluntary, and you can leave at any time.
Who may be eligible?
This study is open to adult women aged 18 and over. Because the trial looks at how birth control pills behave alongside the study drug, participants must be able and willing to take oral contraceptives.
Before taking part, volunteers will have a health check to make sure it is safe for them to join. Women who are currently pregnant, planning a pregnancy, or breastfeeding will not be able to participate, as the effects of the study drug on unborn babies are not yet fully known.
The medical team will review your health history and any other medications you take. Certain existing medical conditions or treatments that could interfere with the study results may mean you cannot take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a woman aged 18 or older.
- I am able and willing to take oral contraceptive pills.
- I am not pregnant and not breastfeeding.
- I can attend regular appointments and have blood tests at the study centre.
- I am willing to use barrier contraception (such as condoms) as a backup during the trial.
What does participation involve?
Taking part involves taking the study medicine (IMU-838) alongside oral contraceptive pills according to a clear schedule provided by the doctors. You will need to attend appointments at a trial clinic so the medical team can monitor your health closely. During these visits, nurses will take blood samples to check drug levels, measure your blood pressure, and carry out routine health checks. Because this is an early pharmacology study, you may need frequent daytime visits or a short stay at the clinic. The study typically lasts several weeks, including an initial screening visit and a final follow-up check once you finish taking the tablets.
Potential risks and benefits
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Common questions
What is IMU-838?
IMU-838 is an experimental tablet being developed to help manage autoimmune conditions, including multiple sclerosis.
Will this replace my regular MS treatment?
No. This is a short-term safety study to see how medications interact, not a long-term treatment plan for MS.
Could my birth control pill stop working during the trial?
Because researchers are testing this exact question, you will be asked to use backup barrier contraception, such as condoms, throughout the study.
Do I have to pay to take part?
No. All study medicines, visits, and tests are free, and travel expenses to the clinic are often covered.
What happens if I decide to leave the study early?
You are free to stop participating at any point. Your decision will not change the standard of healthcare you receive from your normal doctor.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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