Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Ulcerative Colitis

This research study is looking into a new medication called Rosnilimab for adults who have Ulcerative Colitis that is moderate to severe. Ulcerative Colitis is a condition where the lining of your large intestine becomes inflamed. The study aims to find out if Rosnilimab can help improve symptoms, such as how often you need to go to the toilet and how much blood is in your stools. It also checks if the medicine improves the appearance of the bowel lining when seen during an endoscopy. Half the participants will receive Rosnilimab, and the other half will get a placebo (a dummy medicine that looks the same) to fairly compare its effects and safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Anaptysbio Inc.

Enrolment target

Start

28 Mar 2024

Ulcerative Colitis

What is this study about?

If you have Ulcerative Colitis, you know how challenging it can be. This study is exploring a new treatment option called Rosnilimab. It's designed for people whose Ulcerative Colitis is causing noticeable symptoms and affecting their daily lives. The main goal is to see if Rosnilimab can make a real difference in how you feel and how your bowel looks inside, especially compared to not receiving the active medicine. This type of study, called a "Phase 2" trial, is an important step in developing new medicines. It helps us understand if a new drug works as expected and if it's safe enough to continue testing on more people.

To ensure fair results, this study uses a method called "double-blinding." This means that neither you nor your doctor will know whether you are receiving Rosnilimab or a placebo (an inactive substance that looks just like the real medicine). This helps prevent any personal beliefs or hopes from influencing the results. The placebo group is crucial for understanding the true effects of Rosnilimab, as it allows researchers to compare the outcomes in people who received the active drug versus those who didn't.

Throughout the study, doctors and researchers will carefully monitor your symptoms and overall health. They will check how well the medicine is working by looking at your symptoms, like how often you need the toilet, and by examining the lining of your bowel using endoscopies. They will also keep a very close eye on any side effects you might experience to make sure the treatment is safe. Your participation is vital in helping to potentially bring new treatments to people living with Ulcerative Colitis.

Key takeaways

This study is for adults with moderate to severe Ulcerative Colitis.
It tests a new medicine called Rosnilimab against a dummy treatment (placebo).
Neither you nor your doctor will know if you're getting the active medicine or the placebo.
The study aims to see if Rosnilimab improves symptoms and bowel health.
Your safety will be carefully monitored throughout the study.
You can withdraw from the study at any time, for any reason.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The most important thing for joining is that you have been diagnosed with Ulcerative Colitis, and your condition is currently considered moderate to severe. This means your symptoms are likely active and affecting your daily life. The study doctors will perform a check-up and tests to make sure you fit these specific criteria.

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.

Are you 18 years old or older?
Have you been diagnosed with Ulcerative Colitis?
Is your Ulcerative Colitis currently considered moderate to severe by your doctor?
Are you willing to have regular clinic visits, blood tests, and endoscopies?
Are you willing to receive injections as part of the study treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved for about a year. You would have regular visits to the clinic, which will include physical examinations, blood tests, and other health checks. You'll be given either the study medicine (Rosnilimab) or a placebo (a dummy medicine) as an injection. The injections will be given regularly throughout the study period. You and your study doctor won't know whether you are receiving the active medicine or the placebo.

During the trial, you'll be asked to report your symptoms and how you are feeling. Doctors will also perform endoscopies (a procedure to look inside your bowel with a tiny camera) at certain times to see how the lining of your bowel is responding. All these procedures are part of carefully tracking the medicine's effects and ensuring your safety. After you finish receiving the medicine, there will be some follow-up visits to ensure your well-being.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from the new treatment, but there's also a chance you could receive the placebo, which won't directly treat your condition. There could be side effects from the study medicine, even if we don't know what they all are yet, or from the procedures involved. All potential risks and benefits will be fully explained to you before you agree to participate. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Germany
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Unverified
Austria
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Unverified
Spain
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Unverified
Netherlands
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Unverified
Croatia
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Unverified
Romania
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Unverified
Bulgaria
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Unverified
Italy
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Unverified
Poland

Common questions

What is Ulcerative Colitis?

Ulcerative Colitis is a long-term condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops tiny ulcers. This can cause symptoms like tummy pain, diarrhoea, and blood in your stools.

What is Rosnilimab?

Rosnilimab is a new medicine being tested. Researchers believe it might help reduce the inflammation in your bowel that causes Ulcerative Colitis symptoms.

What is a 'placebo'?

A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It's used to fairly compare the real medicine's effects against receiving no active treatment.

Will I know if I'm getting the real medicine?

No, neither you nor your study doctor will know if you are receiving Rosnilimab or the placebo. This is to make sure the study results are as fair and accurate as possible.

How long will the study last?

If you decide to join, your participation in the study, including follow-up, will be for about a year.