Study of Tulisokibart for Patients with Moderately to Severely Active Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying a condition called Ulcerative Colitis, which is a chronic disease that causes inflammation and sores in the digestive tract, specifically affecting the colon and rectum. The study is testing a new treatment called PRA023 to see how safe and effective it is for people with moderate to severe forms of this condition. The treatment will be compared to a placebo to understand its effects better.

The purpose of the study is to evaluate the safety and tolerability of PRA023 over a 12-week period. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor how well the treatment works in helping patients achieve clinical remission, which means a reduction in symptoms and inflammation, by the end of the 12 weeks.

Throughout the study, participants will be closely observed for any side effects or changes in their condition. The goal is to determine if PRA023 can help improve the quality of life for those living with Ulcerative Colitis by reducing symptoms and promoting healing in the colon. This research is important for finding new and effective treatments for this challenging condition.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose and procedures. Written consent is required to confirm understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying a diagnosis of ulcerative colitis and ensuring the participant meets specific health criteria.

3 treatment phase

The treatment phase involves receiving the study medication, PRA023, or a placebo. The medication is administered through an intravenous infusion.

Participants will receive the treatment over a period of 12 weeks. The frequency and dosage will be determined by the study protocol.

4 monitoring and follow-up

Throughout the study, participants will undergo regular monitoring to assess the medication’s effects and any side effects. This includes clinical evaluations and laboratory tests.

Participants will be required to attend scheduled visits to track progress and ensure safety.

5 completion of the study

At the end of the 12-week treatment period, a final assessment will be conducted to evaluate the overall impact of the treatment.

Participants will be informed of the study’s findings and any further steps if necessary.

Who Can Join the Study?

Must be a male or female who is 18 years of age or older.
Must have been diagnosed with Ulcerative Colitis (UC) at least 3 months before the screening. This diagnosis should be confirmed by a procedure called endoscopy (a test that looks inside the body) and histology (examining tissue under a microscope). If there is no previous confirmation, the diagnosis must be confirmed during a screening procedure called a colonoscopy.
Must have moderately to severely active UC. This is determined by a score called the Modified Mayo score, which looks at rectal bleeding, stool frequency, and endoscopy results. The score should be between 4 and 9, with specific scores for endoscopy and rectal bleeding.
Must meet at least one of the following treatment criteria:
- In the past, had an inadequate response to certain treatments like oral prednisone, budesonide, beclomethasone, immunosuppressants (such as azathioprine or 6-mercaptopurine), anti-TNF agents, vedolizumab, JAK inhibitors, anti-IL-12/23, or S1PR modulators.
- Had been intolerant to one or more of these treatments due to side effects.
- Currently receiving certain treatments like oral prednisone or immunosuppressants.
Women who can become pregnant must use two highly effective methods of contraception (birth control) for at least 4 weeks before starting the study and continue until at least 12 weeks after the last dose of the study drug.
Men must use two highly effective methods of contraception with their female partner who can become pregnant and must not donate sperm from the screening to 12 weeks after the last dose of the study drug.
Must meet drug stabilization requirements, meaning certain medications should be at a stable dose for a specific period before starting the study.
Must be able to provide written informed consent, which means agreeing to participate in the study after understanding what it involves.
For a specific group in the study (Cohort 2), subjects must be CDx+ (a specific requirement for that group).

Who Cannot Join the Study?

Patients who have a different condition than Ulcerative Colitis cannot participate. Ulcerative Colitis is a condition where the lining of the large intestine becomes inflamed.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it is important to be within the required age group.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have other health conditions that might interfere with the study or put them at risk cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medication or similar medications cannot participate.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Futuremeds Sp. z o.o.	Wroclaw	Poland
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz	Warsaw	Poland

Other Sites

Site Name	City	Country
Reumed Sp. z o.o.	Lublin	Poland
Sonomed Sp. z o.o.	Szczecin	Poland
Eb Group Sp. z o.o.	Warsaw	Poland
Centrum Medyczne Oporow	Wroclaw	Poland
Vita Longa Sp. z o.o.	Katowice	Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie	Lublin	Poland
Rivermed Sp. z o.o.	Poznan	Poland
Bonifraterskie Centrum Medyczne Sp. z o.o.	Lodz	Poland
Melita Medical sp. z o.o.	Wroclaw	Poland
Semmelweis University	Budapest	Hungary
Hepato-Gastroenterologie HK s.r.o.	Hradec Kralove	Czechia
Centre Hospitalier Universitaire De Nice	Nice	France
Vojenska Nemocnice Brno	Brno-Zidenice	Czechia
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o.	Wloclawek	Poland
Centrum Medyczne Medyk Sp. z o.o.	Rzeszow	Poland
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Ptgbt Ita Cgyszd Swyelj	Neuilly-Sur-Seine	France
Cnqo Dp Nbyqp	Vandoeuvre Les Nancy	France
Wmn Wxqohu Iio Plzum Ppfefxay Kewzbag	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	07.10.2021
France	Not recruiting	07.10.2021
Hungary	Not recruiting	07.10.2021
Poland	Not recruiting	07.10.2021

Trial locations

Investigated drugs:

Tulisokibart

PRA023 is a medication being studied for its potential to help people with moderately to severely active ulcerative colitis. The trial aims to see if PRA023 can safely and effectively reduce the symptoms of ulcerative colitis over a 12-week period. The study will also look at how the body processes the medication. Participants will receive PRA023 to see if it can help them achieve clinical remission, which means a significant reduction or disappearance of symptoms.

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 begins gradually and can become more severe over time, with periods of exacerbation and remission. The inflammation typically starts in the rectum and can extend to involve the entire colon. The exact cause of ulcerative colitis is unknown, 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:

2023-509741-12-00

Protocol code:

PR200-102

NCT ID:

NCT04996797

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tulisokibart for Patients with Moderately to Severely Active Ulcerative Colitis

What is this study about?

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