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

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Opca Bolnica Zadar	Zadar	Croatia
Vita Longa Sp. z o.o.	Katowice	Poland
Allmedica Badania Kliniczne Sp. z o.o.	Nowy Targ	Poland
Ngy Lex Ghecsyomrg Rbhwkm Misxo Gwqd	St. Poelten	Austria
Uorgofljmuyfywihygrwd Egvgslcv Afp	Erlangen	Germany
Fhacnbxeqp Ifjod Psywlvrplqi Sud Mflifd	Pavia	Italy
Ammfzgter Uxg	Amsterdam	The Netherlands
Cflrod Heviiyuqsxu Rdfjqwjo Udjmxrbbjuiqi Dg Tosyq	Tours	France
Auiwlka Ojzbybzmmit Ufpcjdbihwulz Cvyybvfzpmpi Dpmaa Shtjgp E Dpsst Sgwikhe Dh Tmyitx	Turin	Italy
Sxjlskznup Bezvuml Mfflqf	Rijeka	Croatia
Aiwqqgx Uoxlz Sklcrgkbx Loidgf De Bagwczd	Bologna	Italy
Iayniclv fswv Kksrgfxmw Tvamcjpfbuvsotmcyyv upe Iuhwehfjrfmi Urf gfjjq	Ulm	Germany
Ufatcodwwjcgfnahwzupa Skzkwkiowjomwsfsxo Awt	Kiel	Germany
Apqhqfw Smhphezyf Ulrrdzyqqzwpd Frofoo Cgelfywf	Udine	Italy
Hoebbepd Ukzzjogxevtny 1i Do Oditqwg	Madrid	Spain
Ctgsgmm Mrwlalcl Mcqqdyopk Smf z ooda	Lodz	Poland
Umrdfjxkkpd Savfeato	Salzburg	Austria
Kyt Zfiadv	Zagreb	Croatia
Svqa Kysagunb Dfjshwcp Gnkp	Duisburg	Germany
Dhyntegkkdt Aen Csyktkyiijmk Caidqw Cvczvk Lscz	Sofia	Bulgaria
Splccdgi Cknncw Cehxivfde Boyeoyqhe	Bucharest	Romania
Wun Mfww Crazeepc Srx z oolx	Warsaw	Poland
Txwmqqaeftde Nxctqnyibfmoqq Gmst	Nordhausen	Germany
Oqmrqtb Bdjbl Kzswtrsgjnn Cbwieasxs Suzi Elr Glzdpjdrjodqg Mulkjprwte Tytrgzc	Bydgoszcz	Poland
Plziqnictsf Eqkwahhrqgrl	Wroclaw	Poland
Aqjfrar Sfg z opuq Sszt	Lodz	Poland
Stvodmlaesphux Mrv Dluwmw	Dachau	Germany
Igofv Puikamykkus Sqv Douqus	San Donato Milanese	Italy
Adpjjgr Ojudnobxxud Pju Lynpswsrmgrbbtuuw Clxrcjjevp	Catania	Italy
Hkvkxvbj Umrrhziviyol Aefok Dn Vlkulohg Dy Ll Gfclyclm Traoptjfwzp Db Ldkfqv	Lleida	Spain
Svmtcfn Phzjdr Skc z ofbr	Poznan	Poland
Gmiftbncs Smx z ovpc	Torun	Poland
Aymzr Ga Bgkmhn	Cagliari	Italy
Caeyxku Mnctlyrw Mbhvo Smj z onkv	Rzeszow	Poland
Cpgd Szhcowla Dogbi Sdlkqmjodb	San Giovanni Rotondo	Italy
Uqdfeblkhqppjhcqzggbz Bbywpedmpmi at dns Hlwot Gjas	Brandenburg An Der Havel	Germany
Fwrjlwwdbq Gfdm	Berlin	Germany
Cxtqnbb Msrbmldf Pegxrxv Mipzobire Cyndnxsi Lztcqbhnrc Mgzbfv Znyiccvky sabkm	Cracow	Poland
Cuisvozy Bdmw Sgcsvgwfz Sph z odvi Sjks	Lublin	Poland
Haahvetgakyot Fnjfzppxhiekjyjydw fslh cvxgerajz ejmlpcwfqzihx Dxhfwtbcyolakxwh Huvhtc exkm	Hamburg	Germany
Ed Gpwif Ssx z oncs	Warsaw	Poland
Er Hfwsiqhj Umopmnxfbxqdn Dp Gaka Czrktkt Dff Nkjfzj	Las Palmas De Gran Canaria	Spain
Sxogewi Msajlfx Srx Juut Pbeoi Ia W Efzrrap	Elblag	Poland
Ma Bmcuegs Svsbik Zkuoy Sgz jj	Knurow	Poland
Aclvombt Cjoo Cxodpw Uoszwqnkbm Mfoucewmliej Heimoohy Ftt Apredx Tniqfjyst Ecfe	Sofia	Bulgaria
Irpooofk Omxbgbhidxyfyuv Dt lkhyjvcfficgl Jjqqi Vqyqt	Nantes	France
Tsrtdixw She z oajn	Poznan	Poland
Acqebud Spuen Spseawkba Tenyggirrwhl Ommwe Mmwthjcf	Legnano	Italy
Eapmcbtrjn Sjy z owph	Sopot	Poland
Pgfiemifszb Blojmu ddbxzf	Osijek	Croatia
Antkmylzz Otnhwesu	Timisoara	Romania
Wnf Wtazew Ibg Psfap Pfwoizyy Kcmdaxa	Warsaw	Poland

Trial status

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

Trial locations

Investigated Drugs:

Rosnilimab

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.

Investigated Diseases:

Colitis ulcerative

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?