Study on the Effectiveness and Safety of Rosnilimab for Patients with Moderate to Severe Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Ulcerative Colitis, a condition that causes inflammation and sores in the lining of the large intestine. The treatment being tested is called Rosnilimab, which is given as a solution for injection. The study aims to evaluate how effective and safe Rosnilimab is for people with moderate to severe forms of this disease. Participants in the study will receive either Rosnilimab or a placebo, which is a substance with no active medication, to compare the outcomes.

The study will take place over several weeks, during which participants will receive regular injections and attend scheduled visits to monitor their health and the effects of the treatment. The goal is to see if Rosnilimab can help reduce the symptoms of Ulcerative Colitis and improve the quality of life for those affected by this condition. Throughout the study, participants will be closely monitored for any changes in their condition and any potential side effects of the treatment.

By participating in this trial, researchers hope to gather important information that could lead to better treatment options for people with Ulcerative Colitis. The study is designed to ensure the safety and well-being of all participants while providing valuable insights into the potential benefits of Rosnilimab for managing this challenging condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of ulcerative colitis, and previous treatment history.

A surveillance colonoscopy must have been performed within one year prior to the start of the study to rule out dysplasia or colon cancer.

2 baseline assessment

Initial assessments are conducted to establish baseline measurements. This includes a review of medical history and current symptoms.

Participants are required to complete electronic diary entries to document symptoms and bowel movements.

3 treatment administration

Participants receive either rosnilimab or a placebo. Rosnilimab is administered as a solution for injection under the skin (subcutaneous).

The frequency and dosage of the injections are determined by the study protocol and are administered regularly throughout the trial.

4 ongoing assessments

Regular assessments are conducted to monitor the effectiveness and safety of the treatment. This includes measuring changes in symptoms and conducting endoscopic evaluations.

Participants are monitored for any side effects or adverse events, and adjustments to the treatment may be made if necessary.

5 end of treatment evaluation

At the end of the treatment period, a final evaluation is conducted to assess the overall impact of the treatment on ulcerative colitis symptoms.

This includes a comprehensive review of all collected data, including symptom diaries, endoscopic results, and any side effects experienced.

6 follow-up

Participants may be required to attend follow-up visits to monitor long-term effects and gather additional data on the treatment’s impact.

These visits help ensure the continued safety and well-being of participants after the trial concludes.

Who Can Join the Study?

  • Must be a male or female who is 18 years or older.
  • Must have a clinical diagnosis of Ulcerative Colitis (UC) for more than 90 days before the start of the study. This includes having biopsy results that confirm UC, as assessed by the study doctor.
  • Must have moderate to severe active UC, which means a specific score of 5 or more on a test called mMS, with an endoscopy subscore of 2 or more, as reviewed by a central reader at the start of the study.
  • Must have had a surveillance colonoscopy within one year before the study start date, which did not find any potential dysplasia (abnormal cells) or colon cancer.
  • Must have completed at least 3 consecutive or 4 nonconsecutive entries in an eDiary (an electronic diary) within 7 days before the study start date, not counting days when preparing for an endoscopy.
  • Must have a history of not responding well, losing response, or not tolerating at least two different types of standard UC treatments. These treatments include:
    • Aminosalicylates (e.g., sulfasalazine, mesalamine)
    • Corticosteroids (e.g., prednisone, budesonide, dexamethasone)
    • Immunosuppressants (e.g., azathioprine, methotrexate)
    • Calcineurin inhibitors (e.g., cyclosporine, tacrolimus)

Who Cannot Join the Study?

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer in the past five years, except for certain types of skin cancer.
  • Patients who have a history of certain heart conditions.
  • Patients who have a history of certain liver or kidney problems.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Specjalistyczne Gabinety Lekarskie Landa Cracow Poland

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Wsd Medi Clinical Sp. z o.o. Warsaw Poland
Amicare Sp. z o.o. S.K. Lodz Poland
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Universitaetsklinikum Brandenburg an der Havel GmbH Brandenburg An Der Havel Germany
Hospital Universitario 12 De Octubre Madrid Spain
FutureMeds GmbH Berlin Germany
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Eb Group Sp. z o.o. Warsaw Poland
Vita Longa Sp. z o.o. Katowice Poland
Centrum Medyczne Med-Gastr Sp. z o.o. Lodz Poland
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Szpital Miejski Sw. Jana Pawla II W Elblagu Elblag Poland
Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOOD Sofia Bulgaria
Azienda Socio Sanitaria Territoriale Ovest Milanese Legnano Italy
Endoskopia Sp. z o.o. Sopot Poland
Poliklinika Borzan d.o.o. Osijek Croatia
Hamburgisches Forschungsinstitut fuer chronisch entzuendliche Darmerkrankungen HaFCED e.K. Hamburg Germany
Mz Badania Slowik Zymla Sp. j. Knurow Poland
Termedia Sp. z o.o. Poznan Poland
KBC Zagreb Zagreb Croatia
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Opca Bolnica Zadar Zadar Croatia
Universitaetsklinikum Erlangen AöR Erlangen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Synexus Polska Sp. z o.o. Poznan Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Specijalna Bolnica Medico Rijeka Croatia
Gastromed Sp. z o.o. Torun Poland
ARNAS G. Brotzu Cagliari Italy
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Allmedica Badania Kliniczne Sp. z o.o. Nowy Targ Poland
Uniklinikum Salzburg Salzburg Austria
Asociatia Oncohelp Timisoara Romania
Tjktfldgsids Nssjqembebpwcn Gxal Nordhausen Germany
Scqo Kfrpaief Dmjhzukv Gded Duisburg Germany
Oxsvdow Bxgjv Kbzbvxajmcv Ckablvqkz Sejs Egp Gvusbpeqynhea Mrqsdnbxwj Tvmhvry Bydgoszcz Poland
Pwtrfyemrpe Efnzmatrdfns Wroclaw Poland
Scqysjfnfrvsap Mvu Dsaikl Dachau Germany
Ayehhqevr Uud Amsterdam The Netherlands
Aojjhni Oskzwalvksc Pur Ltswrildefsmwurpn Ceuoycydih Catania Italy
Cubvsg Hwckjrlbcgi Rewkdesy Utefynuluooju Dq Trwhq Tours France
Azjvbef Ojmetfzaibk Uqcawlvhjinql Ctrnjtgenzjn Dfnks Sauqje E Dfkqp Sktsbsj Dk Tkmmpd Turin Italy
Aalhhvk Ugeds Svofjedil Larzhe Df Bdmrcuj Bologna Italy
Inaweidk Ozxibmvztraqwpv Du lazuluwocipfk Jwmiw Vqjho Nantes France
Wom Wiwvbm Iej Pmzga Plyqqltl Kuxxhtr Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.05.2024
Bulgaria Bulgaria
Not recruiting
01.05.2024
Croatia Croatia
Not recruiting
01.05.2024
France France
Not recruiting
01.05.2024
Germany Germany
Not recruiting
01.05.2024
Italy Italy
Not recruiting
01.05.2024
Poland Poland
Not recruiting
01.05.2024
Romania Romania
Not recruiting
01.05.2024
Spain Spain
Not recruiting
01.05.2024
The Netherlands The Netherlands
Not recruiting
01.05.2024

Trial locations

Investigated drugs:

Rosnilimab is a medication being studied for its potential to help people with moderate to severe ulcerative colitis, a condition that causes inflammation and sores in the colon. The trial aims to see how well this medication works in reducing the symptoms of ulcerative colitis and improving the overall health of the colon.

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission. Over time, the inflammation can cause the colon to become less effective at absorbing water and nutrients, leading to further complications. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response in the gut. Environmental factors, genetics, and an imbalance in gut bacteria may also play a role in its development.

Trial ID:
2023-508679-34-00
Protocol code:
ANB030-204
Trial Phase:
Therapeutic exploratory (Phase II)

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