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CLINICAL TRIAL

Crohn's Disease:
Developing a New Treatment for Patients

If you suffer from Crohn’s disease, this study with a new active substance could be interest-ing for you. Fill out this non-binding questionnaire to find out whether you’re eligible.

Dear Patient,

Whether at work, in family life, or at home: Crohn’s disease, a chronic inflammatory bowel disease, can restrict many areas of life and be a burden. The search for effective treatment can be draining and may even require injections, visits to the doctor, or stays in the hospital.

Development of a new treatment for Crohn’s disease
But the development of new therapies for Crohn’s disease is making progress. We are currently conducting the YELLOWSTONE Study Programme. These are global phase III clinical trials for patients with moderate to severe Crohn’s disease. We are testing the efficacy and tolerability of new investigational medicine. The investigational drug is swallowed as a capsule, reduces the activity of the immune system, and could thus reduce inflammation in the gut. This is indicated by results from the previous phase II clinical trial1. Can the investigational drug possibly reduce disease activity and therefore alleviate symptoms? The YELLOWSTONE Study Programme aims to answer questions like these. A total of 1,200 patients worldwide are planned to participate.

Crohn’s disease patients can now participate
If you suffer from Crohn’s disease, this study programme could be interesting for you. Participation in the study is entirely free of charge. You can find out more about the clinical trial on our website. Feel free to use our non-binding questionnaire to find out whether you are eligible to participate.

Thank you for your interest in the YELLOWSTONE Study Programme,

Dr. Peter Irving

National Coordinating Investigator

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"The investigational drug can be swallowed as a capsule."

Dr. Peter Irving


National Coordinating Investigator

Consultant Gastroenterologist

St Thomas’ Hospital, London

STUDY MANAGEMENT

The national coordinating investigator of the YELLOWSTONE Study Programme

United Kingdom

Dr. Peter Irving

Consultant Gastroenterologist
St Thomas’ Hospital, London

About Dr. Irving

STUDY PROGRAMME

What Is the YELLOWSTONE Study Programme?

The YELLOWSTONE Study Programme comprises three clinical studies: an entry study (also called an induction study), a maintenance study, and an open-label extension study. Patients who want to take part in the YELLOWSTONE Study Programme first start with the induction study. Depending on your clinical improvement, you decide with the investigator whether you wish to continue participating in the study programme. You can also drop out at any time. You can find out more here. The YELLOWSTONE Study Programme at a glance:

CRITERIA

Are You Eligible for the Induction Study?

The YELLOWSTONE induction study is aimed at adults with moderate to severe Crohn’s disease.

You may be eligible to participate in the induction study if:

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You are between 18 and 75 years old.

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A doctor has diagnosed you with Crohn's disease.

You have already received at least one medication for Crohn's disease, and it has not led to a lasting improvement, or you have had to stop it due to side effects.

Participation in the induction study is not possible if, for example, the following applies:

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You also have another chronic inflammatory bowel disease such as ulcerative colitis.

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You have a surgical procedure on the gastrointestinal tract within the next three months.

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You cannot have a colonoscopy.

PARTICIPATION

How to Participate in the YELLOWSTONE Study Programme

STEP

1

Obtain information

Find out the details of the YELLOWSTONE Study Programme at your leisure on this website. Answers to the most important questions about the study programme can be found here.

STEP

2

Fill in the questionnaire

A questionnaire will tell you whether you are eligible to take part in the YELLOWSTONE Study Programme. Afterwards, our Patient Information Service will be available to answer your questions and clarify the next steps with you.

STEP

3

Make an appointment

If you are interested in participating, talk to a study doctor without obligation. Only after your appointment will you decide together with your attending doctor whether to participate.

AT A GLANCE

What Will I Face during the Induction Study?

You will not incur any costs by participating in the study. Read more.
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12

weeks

of treatment.

5

visits

on site.

3

ECGs

will be performed.

2

colonoscopies with biopsies

will be conducted.

MorbusCrohn-Studie_Mann_schau_aus_Fenster_Foto_web-V1

12

weeks

of treatment.

5

visits

on site.

3

ECGs

will be performed.

2

colonoscopies with biopsies

will be conducted.

STUDY SITES

Location of the YELLOWSTONE Study Programme

United Kingdom

6

Locations

Worldwide

1,200

Participants

PROCEDURE

This is how the induction study works in detail

CONTACT

Are there any unanswered questions? Get in touch!

ONLINE GUIDE

Living with
Crohn's disease: Compact guide 2021

STUDY SITES

Conducted by

FAQ

Frequently Asked Questions

An investigational drug is a medicine not yet approved for a specific disease. It is therefore being studied in clinical trials for the treatment of said specific disease. The active substance contained in the investigational drug may be already approved for treating other diseases.
In patients with Crohn’s disease, certain signalling molecules cause more immune cells to migrate into the intestinal mucosa, accumulate there and promote inflammation. The investigational drug leads to a certain type of immune cells (especially T cells) no longer being able to leave the lymphatic tissue. Scientists assume that this also means that fewer of these cells can migrate into the intestinal mucosa. This may reduce the inflammation in the gut.
Yes. The investigational drug is suitable for treating various diseases involving chronic inflammation caused by an overactive immune system. These diseases include the chronic inflammatory bowel disease ulcerative colitis or the neurological disorder multiple sclerosis (short: MS). In total, more than 5,000 people have already received the active substance within various clinical studies. The active substance has been approved to treat relapsing-remitting multiple sclerosis (RRMS) in the USA, Europe and Switzerland since 2020.2,3,4 In addition, the phase III study programme in ulcerative colitis was completed this year. In this trial, the active substance was able to significantly and sustainably improve symptoms. Since May 2021, it has also been available to patients with ulcerative colitis in the USA.5. The European authorities are currently reviewing the application for approval. And: There are preliminary results from a phase II study in the treatment of patients with Crohn’s disease, which indicate that the investigational drug could be effective and tolerable as well.6. In order for the investigational drug to be approved in the treatment of Crohn’s disease, we are now conducting the phase III trials as part of the YELLOWSTONE Study Programme.
Yes, this is generally possible, but it depends on the medication you are currently taking. If you qualify to take part in the study, your study doctor will again clarify with you whether you can continue to take your current medication. If you wish, you can also involve your treating doctor in the decision-making process. Generally, common medicines for Crohn’s disease, such as aminosalicylates or cortisone, can still be taken in a certain dosage as basic therapy. However, the dose of these medications must not be changed, at least during the induction study.
The YELLOWSTONE induction study has a 2:1 ratio of investigational drug to placebo. So the probability that you will receive the investigational drug containing the active substance is 67 per cent (2 out of 3). The probability that you will receive the placebo is 33 per cent. In the maintenance study, the investigational drug is also controlled with placebo using a ratio of 1:1. Here, the probability for receiving either the investigational drug and the placebo is, therefore 50 per cent each. If you have received a placebo during the induction study and showed a clinical response, you will continue to take a placebo during the maintenance study. Neither you nor your study doctor or anyone else involved in the study will be told which treatment you are receiving. This is also called “blinding”. In certain situations, such as a medical emergency, you may be unblinded. This means that your study doctor or the study team will then learn whether you are receiving the study drug or placebo.

Are you interested in the YELLOWSTONE Study Programme?

Find out now, without obligation, via our questionnaire whether you are eligible for study participation.

  • Feagan et al., Lancet Gastroenterol Hepatol 2020 Jun 15;S2468-1253(20)30188-6.
  • Bristol Myers Squibb. Press Release, 26 March 2020. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-approves-bristol-myers-squibbs (last accessed April 2020).
  • European Medicines Agency: Assessment Report. 9 April 2020. https://www.ema.europa.eu/en/documents/assessment-report/zeposia-epar-public-assessment-report_en.pdf (last accessed August 2020).
  • Approval of Zeposia in Switzerland, https://www.swissmedic.ch/swissmedic/de/home/humanarzneimittel/authorisations/new-medicines/zeposia_hartkapseln_ozanimodum.html (last accessed June 2021)
  • Bristol Myers Squibb. Press Release. https://news.bms.com/news/corporate-financial/2021/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Zeposia-ozanimod-an-Oral-Treatment-for-Adults-with-Moderately-to-Severely-Active-Ulcerative-Colitis1/default.aspx (last accessed June 2021)
  • Sandborn WJ, et al. N Engl J Med. 2016; 374:1745-1762