MONOlith Study

Written By sanja frkanec

Patients with Ulcerative Colitis (UC) are being recruited for a clinical study currently ongoing at Charité Research Organisation (study site) in Berlin, Germany.

This study is aiming to investigate a new investigational medicinal product and to better understand its safety and effects in patients with UC.

Participation in this study is entirely voluntary.

The study has been approved by the competent national authority (Paul-Ehrlich Institut [PEI]) with the involvement of the responsible Ethics Committee and is conducted in accordance with Good Clinical Practice (GCP) and the German Medicines Act (AMG).

What is this study about?

This is a clinical research study for adults with Ulcerative Colitis. The study is testing a new investigational medicine to learn more about its safety and effects.

Your participation will contribute to advance research and to further improve understanding of Ulcerative Colitis

Who may be able to take part?

German-speaking patients can participate in the study.

You can participate if you: *

  • Are a man or a woman >18 years of age

  • Have been diagnosed with Ulcerative Colitis (UC)

  • have a body mass index (BMI) between 18 and 32 and a total body weight between 50 - 100 kg

  • Smoke no more than 10 cigarettes a day or don't smoke at all.

*Other eligibility criteria also apply. Only the study team at the study site can confirm whether someone is eligible after providing detailed information and performing screening assessments.

Do I have to join if I ask for information?

No. Asking for information does not mean you have to take part. The decision is always yours.

There are also information sessions available at the study site. Please refer to the contact details below.

What else do I need to know?

If you contact the study site, the study team will give complete information about:

  • The care and study medication provided (all at no cost for you)

  • The investigational medicinal product that you will receive during the study treatment period which you will get for either 8 consecutive weeks or 4 weeks of placebo + 4 consecutive weeks of investigational medicinal product.

  • What examinations and study visits are planned (e.g. inpatient stays, outpatient appointments at the study site, study participation duration etc.)

  • Possible risks and potential benefits

  • Your rights as a study participant

  • Entitled compensation for time, effort and travel expenses.

You will have sufficient time to ask questions before deciding whether to take part. Participation requires written informed consent, and you may withdraw from the study at any time.

Can I stop participating?

Yes. Taking part is voluntary. You can stop at any time without giving a reason and without any disadvantage for your medical care.

Is my data protected?

Yes. Your personal data will be treated confidentially and protected according to data protection laws (GDPR).

Interested in learning more?

For further information about the investigational treatment, the examinations and the required visits, contact the study team at Charité Research Organisation (Berlin) directly:

https://probanden.charite-research.de/colitis_ulcerosa_studie?cro=ifcca

Requesting information does not obligate you to participate.

Official Study Brief Title: A study in healthy volunteers and patients with ulcerative colitis to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GRT-001 (MONOlith trial).

Protocol number: GRT-1C101

Ethics/Regulatory approval: Responsible EC and Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines

Study ID (EU-CT): 2023-507547-11

Status: Ongoing / Enrolling

sanja frkanec
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