Study on the Effects of Eclitasertib in Adults 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 medication called SAR443122 in adults with moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of the large intestine. The purpose of the study is to assess how effective and safe different doses of SAR443122 are for treating this condition.

Participants in the study will receive either the medication SAR443122 or a placebo, which looks like the medication but does not contain the active ingredient. The medication is taken orally in the form of a hard capsule. The study will last for up to 52 weeks, during which participants will be monitored to see how well the treatment works and to check for any side effects. The main goal is to see if participants achieve clinical remission, meaning their symptoms improve significantly, by the 12th week of the study.

Throughout the study, various assessments will be conducted to evaluate the participants’ response to the treatment. These assessments include checking for improvements in symptoms, such as stool frequency and rectal bleeding, as well as examining the condition of the colon through endoscopy, a procedure that allows doctors to look inside the colon. The study will also track any adverse events, which are any unwanted effects that occur during the treatment period. The results will help determine the most effective dose of SAR443122 for managing ulcerative colitis.

1 joining the study

Upon joining the study, you will be randomly assigned to receive either the study medication, SAR443122, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

2 medication administration

You will take the medication in the form of a hard capsule by mouth. The specific dosage and frequency will be determined by the study team and may vary as the study aims to find the most effective dose.

3 treatment period

The treatment period will last for 12 weeks. During this time, you will continue to take the assigned medication as instructed.

4 regular assessments

Throughout the study, you will undergo regular assessments to monitor your health and the effects of the medication. These assessments may include physical exams, blood tests, and questionnaires about your symptoms and quality of life.

5 end of treatment evaluation

At the end of the 12-week treatment period, your condition will be evaluated to determine if there has been any improvement in your symptoms. This will involve a review of your symptom scores and possibly an endoscopy, which is a procedure to look inside your colon.

6 follow-up

After the treatment period, there may be additional follow-up visits to monitor your health and gather further information about the long-term effects of the medication.

Who Can Join the Study?

  • Participants must have clinical evidence of active Ulcerative Colitis (UC) for at least 3 months before the screening, confirmed by a procedure called endoscopy during the screening period.
  • Participants must have a minimum disease extent of 15 centimeters from the anal verge (the opening of the anus).
  • Participants must have not responded well, stopped responding, or cannot tolerate at least one of the following approved treatments: amino-salicylate, corticosteroids, immunosuppressants, biologics (except natalizumab, also known as Tysabri®), or small molecules.
  • Participants taking corticosteroids (a type of medication that reduces inflammation) must be on a stable dose for at least 2 weeks before and during the screening period.
  • Participants taking methotrexate, azathioprine, or 6-mercaptopurine (medications that suppress the immune system) must have been on treatment for at least 8 weeks before screening and on a stable dose for at least 4 weeks before and during the screening period.
  • Participants taking oral 5-aminosalicylates, mesalamine, or sulfasalazine (medications used to treat inflammation) must be on a stable dose for at least 4 weeks before and during the screening period.
  • Participants on advanced therapies must have either had their last dose at least 5 half-lives before randomization or have undetectable levels of the biologic in their blood before randomization. A half-life is the time it takes for the concentration of a drug in the body to reduce by half.
  • Participants must use contraception according to local regulations. Women should not be pregnant or breastfeeding.

Who Cannot Join the Study?

  • Patients with any other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who have had recent surgery or are planning to have surgery during the study period.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients with certain infections that could affect the study results.
  • Patients who are taking medications that might interfere with the study treatment.
  • Patients with a history of certain types of cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Futuremeds Sp. z o.o. Wroclaw Poland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Gyncentrum Sp. z o.o. Katowice Poland

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
Wsd Medi Clinical Sp. z o.o. Warsaw Poland
Bekes Varmegyei Koezponti Korhaz Bekescsaba Hungary
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Semmelweis University Budapest Hungary
Philipps-Universitaet Marburg Marburg Germany
Clinexpert Kft. Budapest Hungary
IRCCS Policlinico San Donato San Donato Milanese Italy
Central Hospital Of Bolzano Bolzano Italy
Centre Hospitalier Regional Universitaire De Nancy Nancy France
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Hospital Ruber Juan Bravo Madrid Spain
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
KM Management spol. s r.o. Nitra Slovakia
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Centrum Diagnostyczno Lecznicze Barska Sp. z o.o. Wloclawek Poland
Centro Medico Teknon-Grupo Quironsalud Barcelona Spain
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Iscare a.s. Prague Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Virgen Del Consuelo Valencia Spain
Vita Longa Sp. z o.o. Katowice Poland
MEDIC KRAL s.r.o. Prague Czechia
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Nemocnice Ceske Budejovice a.s. Ceske Budejovice Czechia
Gastro Jeka s.r.o. Klatovy Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Lecznej Leczna Poland
Specjalistyczne Gabinety Lekarskie LANDA Cracow Poland
Aanasne Couzqaj Spjyif Bucharest Romania
Shgoqbeyp Rawmbkd Uriwpipwep Mbqqspx Ctwmhz Nijmegen The Netherlands
Prfhojasi Ipjicyuv Mubsgnqz Mewhpasemfge Sysnq Wlbylgxksdyf I Agubrurslfzgl Warsaw Poland
Sut Mfzfae Uno Sop Aogvephrxdtgnokjdlbvl Ludwigshafen Am Rhein Germany
Ahnnouo Oohpxentjxv Osxmvawg Riuivgw Vbwjr Sdrai Cyyzyfmr Palermo Italy
Acyfpqifr Ufw Amsterdam The Netherlands
Aedlmfqdyl Pwmlckqg Hadurwnq Dh Mpgdpxppm Marseille France
Svv Ezlsfpltg Hhwnbhck Txfoyga Tilburg The Netherlands
Ufpszdnpuv Mnjzl Gnbfguz Ob Cqntytzxo Catanzaro Italy
Fhyhvbabc Pbgk Lu Ikunkbjitkjvx Bfouyjoxq Dbu Htryrcey Ulderfhpmewli Ls Pam Madrid Spain
Ialtjdou Oghjwakptkdserd Dk llqnfuflwudqs Jewke Vjybf Nantes France
mnrelh Kfdjqhqg giqpy Ostfildern Germany
Mzrqqgn Cgzcdn Hyviudaey Dkogkls Flozoa Budapest Hungary

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
30.04.2023
Czechia Czechia
Not recruiting
30.04.2023
France France
Not recruiting
30.04.2023
Germany Germany
Not recruiting
30.04.2023
Hungary Hungary
Not recruiting
30.04.2023
Italy Italy
Not recruiting
30.04.2023
Poland Poland
Not recruiting
30.04.2023
Romania Romania
Not recruiting
30.04.2023
Slovakia Slovakia
Not recruiting
30.04.2023
Spain Spain
Not recruiting
30.04.2023
The Netherlands The Netherlands
Not recruiting
30.04.2023

Trial locations

Investigated drugs:

SAR443122 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 and rectum. This medication is being tested to see if it can reduce the symptoms of ulcerative colitis and improve the quality of life for patients. The study is looking at how effective and safe this medication is when used during the initial treatment period. By participating in this trial, researchers hope to find out if SAR443122 can be a beneficial treatment option for those suffering from this condition.

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. The disease typically begins in the rectum and can extend to involve the entire colon. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The inflammation can lead to frequent and urgent bowel movements. Over time, the disease can cause complications such as severe bleeding or perforation of the colon.

Trial ID:
2022-500290-14-01
Protocol code:
DRI16804
NCT ID:
NCT05588843
Trial Phase:
Therapeutic exploratory (Phase II)

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