Study on the Effects of MORF-057 for Adults with Moderate to Severe Crohn’s Disease

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for Crohn’s Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The treatment being tested is called MORF-057, which is taken in the form of a capsule. The study will compare the effects of two different doses of MORF-057 to a placebo, which looks like the treatment but does not contain the active medicine.

The purpose of the study is to evaluate the safety and effectiveness of MORF-057 in adults with moderately to severely active Crohn’s Disease. Participants will be randomly assigned to receive either MORF-057 or a placebo. The study will last for several weeks, during which participants will take the capsules and attend regular check-ups to monitor their health and the effects of the treatment.

Throughout the study, doctors will use a method called endoscopy to look inside the digestive tract and assess how well the treatment is working. The main goal is to see if MORF-057 can help reduce the inflammation and improve symptoms by the end of the study period. Participants will also be monitored for any side effects or changes in their health to ensure the treatment is safe.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

The assessment ensures that the participant has moderately to severely active Crohn’s disease, confirmed by specific scores from medical evaluations.

2 treatment allocation

Participants are randomly assigned to receive either the active medication, MORF-057, or a placebo. The study is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

The medication is provided in capsule form for oral use.

3 medication administration

Participants take the assigned capsule daily. The dosage and specific regimen are determined by the study protocol.

The treatment period lasts for 14 weeks, during which the participant’s response to the medication is closely monitored.

4 monitoring and assessments

Regular assessments are conducted to monitor the participant’s health and response to the treatment. This includes checking for any side effects and evaluating the effectiveness of the medication.

Endoscopic evaluations are performed to assess the condition of the intestines at the end of the 14-week period.

5 final evaluation

At the end of the treatment period, a final evaluation is conducted to determine the participant’s response to the treatment.

The primary goal is to assess the proportion of participants who show an endoscopic response, indicating improvement in the condition.

Who Can Join the Study?

  • Must be a male or female between 18 to 85 years old.
  • Must have been diagnosed with Crohn’s Disease (CD) for at least 3 months. This diagnosis should be supported by symptoms, an endoscopy (a procedure to look inside the digestive tract), and a biopsy (a small tissue sample).
  • Must have moderately to severely active Crohn’s Disease, confirmed by specific scores during the screening period.
  • Must have an average daily stool score of 4 or more points and/or an average daily abdominal pain score of 2 or more points.
  • Must have shown an inadequate response, loss of response, or intolerance to at least one treatment for Crohn’s Disease, such as corticosteroids, immunosuppressants, or advanced therapies.
  • Must meet specific washout criteria for previous Crohn’s Disease therapies, meaning certain medications must be stopped for a specific time before starting the study.
  • If taking certain non-prohibited medications for Crohn’s Disease, must stop them at least 5 half-lives before the study or agree to maintain stable doses, except for tapering oral corticosteroids after the induction period.
  • Must have a body mass index (BMI) of 18.0 or higher. BMI is a measure of body fat based on height and weight.
  • Must be able to fully participate in all aspects of the study, as determined by the investigator.
  • Must agree to follow guidelines regarding contraception. This includes using effective birth control methods or abstaining from sexual intercourse during the study and for a specified time after the last dose of the study medication.
  • Must agree not to donate sperm or eggs during the study and for a specified time after the last dose of the study medication.
  • Must be capable of giving signed informed consent, which means understanding and agreeing to the study’s requirements and restrictions.

Who Cannot Join the Study?

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
Hospital Universitario Y Politecnico La Fe Valencia Spain
Opca Bolnica Virovitica Virovitica Croatia
Centrul Medical Sfanta Vineri S.R.L. Bucharest Romania
Medical University Of Vienna Vienna Austria
DRK Kliniken Berlin Berlin Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
IRCCS Humanitas Research Hospital Rozzano Italy
Specjalistyczne Gabinety Lekarskie Landa Cracow Poland

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
Pauls Stradins Clinical University Hospital Riga Latvia
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Wsd Medi Clinical Sp. z o.o. Warsaw Poland
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
San Camillo Forlanini Hospital Rome Italy
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Area Sanitaria De Ferrol Ferrol Spain
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
Eb Group Sp. z o.o. Warsaw Poland
Centrum Medyczne Oporow Wroclaw Poland
Vita Longa Sp. z o.o. Katowice Poland
Szpital Miejski Sw. Jana Pawla II W Elblagu Elblag Poland
Endoskopia Sp. z o.o. Sopot Poland
SurGal Clinic s.r.o. Brno-Sever Czechia
Poliklinika Borzan d.o.o. Osijek Croatia
Gastro LM s.r.o. Presov Slovakia
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Clinfan Kft. Szekszard Hungary
Opca Bolnica Zadar Zadar Croatia
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Lleida Spain
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Synexus Polska Sp. z o.o. Poznan Poland
Liepajas Regionala Slimnica SIA Liepaja Latvia
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Specijalna Bolnica Medico Rijeka Croatia
Cliniq s.r.o. Bratislava Slovakia
H-T. Centrum Medyczne Sp. z o.o. Tychy Poland
Poliklinika Solmed d.o.o. Zagreb Croatia
Spitalul De Oncologie Monza S.R.L. Bucharest Romania
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Etg Neuroscience Sp. z o.o. Warsaw Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
IRCCS Ospedale Sacro Cuore Don Calabria Negrar di Valpolicella Italy
Uniklinikum Salzburg Salzburg Austria
EMC Instytut Medyczny S.A. Poznan Poland
Clinoxus s.r.o. Prague Czechia
Asociatia Oncohelp Timisoara Romania
R57 Sp. z o.o. Cracow Poland
Aaeo Cyxqhcvq stlpyy Prague Czechia
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Mxnjidaozndcuilngxxulacmfb Hdpsgtwsjcnxwzve Halle (Saale) Germany
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Ncbicnu Rybkzg Kappbvl Bytom Poland
Oukudkc Biqns Kmmnwpdsbub Cwlibqsqg Sdca Ebc Guzecncnhszrn Mmpizuubhq Tcokrkc Bydgoszcz Poland
Mwtfqxjf Sw z orlk Bydgoszcz Poland
Cgnm Dh Nvkcg Vandoeuvre Les Nancy France
Akkhrrw Usfkq Spzzyopim Lpwpvw Dt Blserlb Bologna Italy
Flfbdfplw Poca Lh Imhiraeekiocr Bsmaqzvtw Dzf Hhwsirkr Ucbvtvnxsmcfy Lv Pxp Madrid Spain
Grcct Bwckrgl Kuttudajv Sfx z ozas Klodzko Poland
Slvzndvrzoecyr Myz Dcxlvw Dachau Germany
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Wph Wnjfyw Ild Ptetx Plhepgbp Kxyhrtm 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
Recruiting
21.06.2024
Croatia Croatia
Recruiting
21.06.2024
Czechia Czechia
Recruiting
21.06.2024
France France
Recruiting
21.06.2024
Germany Germany
Recruiting
21.06.2024
Hungary Hungary
Recruiting
21.06.2024
Italy Italy
Recruiting
21.06.2024
Latvia Latvia
Recruiting
21.06.2024
Poland Poland
Not recruiting
21.06.2024
Romania Romania
Recruiting
21.06.2024
Slovakia Slovakia
Recruiting
21.06.2024
Spain Spain
Recruiting
21.06.2024

Trial locations

Investigated drugs:

MORF-057 is a medication being studied for its potential to help people with moderately to severely active Crohn’s Disease. The trial aims to see how well this medication works in reducing inflammation in the intestines, which is checked through a procedure called an endoscopy. The study will assess the effects of this medication over a period of 14 weeks to determine its safety and effectiveness in improving the symptoms of Crohn’s Disease.

Investigated diseases:

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active symptoms and remission. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can lead to complications such as strictures or fistulas. The exact cause is unknown, but it involves an abnormal immune response. The disease can vary greatly in severity and progression among individuals.

Trial ID:
2023-508158-24-00
Protocol code:
MORF-057-203
NCT ID:
NCT06226883
Trial Phase:
Therapeutic exploratory (Phase II)

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