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Study on the Effects of MORF-057 for 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 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 MORF-057, which is taken as a capsule. The study aims to evaluate how well this treatment works in helping patients achieve a state where their symptoms are significantly reduced or gone, known as clinical remission, by the 12th week of the study.

Participants in the study will be randomly assigned to receive either the MORF-057 capsule or a placebo, which looks like the treatment but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations about the treatment’s effectiveness.

The study will last for up to 52 weeks, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The main goal is to see how many participants achieve clinical remission by the 12th week, with additional observations continuing throughout the study period to assess longer-term effects and safety. This research is important for understanding how MORF-057 might help people with moderately to severely active ulcerative colitis manage their condition more effectively.

1 beginning of the trial

Upon joining the study, you will be randomly assigned to receive either the investigational medication MORF-057 or a placebo. A placebo is a capsule that looks like the medication but does not contain the active substance.

The study is designed to be double-blind, meaning neither you nor the study team will know which treatment you are receiving. This is to ensure unbiased results.

2 medication administration

You will take the assigned capsule orally. The dosage and frequency will be determined by the study protocol, and you will be informed of these details at the start of the trial.

The treatment period is planned to last for 12 weeks, during which you will continue taking the capsules as instructed.

3 regular assessments

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

The primary goal is to evaluate the effects of MORF-057 on achieving clinical remission by Week 12.

4 end of treatment period

At the end of the 12-week treatment period, your response to the medication will be evaluated using the Modified Mayo Clinic Score (mMCS), which assesses stool frequency, rectal bleeding, and endoscopic findings.

You may be asked to continue with follow-up visits to monitor your condition and any long-term effects of the treatment.

5 follow-up period

After completing the treatment period, there will be a follow-up period to observe your health status and any changes in your condition.

This period may include additional assessments at specified intervals, such as Weeks 52 and 104, to gather further data on the long-term effects of the treatment.

Who Can Join the Study?

  • Must be a male or female aged between 18 and 85 years old.
  • Must agree to follow the study’s guidelines on contraception (methods to prevent pregnancy) during the study and for a short period after.
  • Must agree not to donate sperm or eggs during the study and for a short period after.
  • Must be able to give informed consent, meaning you understand the study and agree to participate.
  • Must have been diagnosed with ulcerative colitis (UC) for at least 3 months before the study starts.
  • Must have moderately to severely active UC, confirmed by specific medical tests.
  • Must have UC that affects at least 15 cm from the anal verge (the end of the digestive tract).
  • Must have tried and not responded well to, or not tolerated, at least one previous treatment for UC, such as certain medications or therapies.
  • Must meet specific washout criteria, meaning you have stopped certain UC medications for a specified time before starting the study.
  • If taking certain allowed medications for UC, must either stop them before the study or agree to keep the dose stable during the study.
  • If you have had UC for more than 7 years, must have had a full colonoscopy (a test to look inside the colon) in the last 2 years or agree to have one at the start of the study.
  • Must be considered able to fully participate in the study by the study doctor.
  • Must have a body mass index (BMI) of at least 18.0, which is a measure of body weight based on height and weight.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a history of heart disease or stroke.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of liver or kidney disease.
  • Patients who have a history of mental health disorders that are not well controlled.
  • Patients who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Centre Hospitalier Universitaire De Lille Lille France
Futuremeds Sp. z o.o. Wroclaw Poland
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Laane-Tallinna Keskhaigla AS Pohja-Tallinna Linnaosa Estonia
Liepajas Regionala Slimnica SIA Liepaja Latvia
Centre Hospitalier Universitaire De Nice Nice France
Cliniq s.r.o. Bratislava Slovakia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Pauls Stradins Clinical University Hospital Riga Latvia
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Semmelweis University Budapest Hungary
Javorszky Odon Korhaz Vac Hungary
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
PreventaMed s.r.o. Olomouc Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Krankenhaus Waldfriede e.V. Berlin Germany
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Medical Center Teodora EOOD Ruse Bulgaria
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j. Staszow Poland
Vita Longa Sp. z o.o. Katowice Poland
Ip Clinic Sp. z o.o. Lodz Poland
Centrul De Diagnostic Si Tratament Provita S.A. Bucharest Romania
Szpital Miejski Sw. Jana Pawla II W Elblagu Elblag Poland
Endoskopia Sp. z o.o. Sopot Poland
Respublikine Panevezio ligonine VšĮ Panevezys Lithuania
Gastro LM s.r.o. Presov Slovakia
EMC Instytut Medyczny S.A. Wroclaw Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Uniklinikum Salzburg Salzburg Austria
Clinoxus s.r.o. Prague Czechia
Innomedica OÜ Nomme Linnaosa Estonia
Cwmt Da Nfjzp Vandoeuvre Les Nancy France
Ewtmozx seegkt Kosice Slovakia
Pxhbffv Mhdyed Szz z Okss Ejt Pzpfnqdem Poniatowa Poland
Oikqmrl Bbjiq Kuaynvnvokd Cbspmibry Shwg Ese Gjaevpulflehf Mqfrjfsxmq Tcgtgmk Bydgoszcz Poland
Nafxzdg Rcoyse Klpqtar Bytom Poland
Eii Lohikc Lublin Poland
Ohetngovyvxgkx Llrj Gkhq Linz Austria
Ivbttchw dp Cxysfroqrvrq Hfbtjohqshi Ufargvifbgodt dr Spfrq Ecrvccs (qbiqeje Saint Priest En Jarez France
Wom Webvzp Itv Ptswo Pfqqumnz Kkykyfl Warsaw Poland
Eglr Tkvkwxr Cxtxhdx Huwhvzwe Tallin Estonia

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
15.03.2023
Bulgaria Bulgaria
Not recruiting
15.03.2023
Czechia Czechia
Not recruiting
15.03.2023
Estonia Estonia
Not recruiting
15.03.2023
France France
Not recruiting
15.03.2023
Germany Germany
Not recruiting
15.03.2023
Hungary Hungary
Not recruiting
15.03.2023
Italy Italy
Not recruiting
15.03.2023
Latvia Latvia
Not recruiting
15.03.2023
Lithuania Lithuania
Not recruiting
15.03.2023
Poland Poland
Not recruiting
15.03.2023
Romania Romania
Not recruiting
15.03.2023
Slovakia Slovakia
Not recruiting
15.03.2023

Trial locations

Investigated drugs:

MORF-057 is a medication being tested to see if it can help people with ulcerative colitis, which is a condition that causes inflammation and sores in the colon. The trial is looking at how well this medication can help patients achieve clinical remission, meaning that their symptoms are reduced or disappear, after 12 weeks of treatment. The study is designed to compare different amounts of MORF-057 to see which one works best and is safest for patients.

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 the colon to lose its ability to function properly.

Trial ID:
2022-500953-17-00
Protocol code:
MORF-057-202
Trial Phase:
Therapeutic exploratory (Phase II)

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