RecruitingPhase 2NCT06226883

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)

Sponsor

Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Enrollment

385 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Inflammatory Bowel Diseases Crohn's Disease

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called MORF-057 for adults with moderate to severe Crohn's disease — a chronic inflammatory bowel condition. It is a Phase 2 study looking at how well and safely the drug works. **You may be eligible if...** - You have had signs and symptoms of Crohn's disease for at least 90 days - Your disease is moderately to severely active based on standard scoring tools - You have not responded well to, lost response to, or cannot tolerate at least one previous treatment (such as steroids, immunosuppressants, or biologics) **You may NOT be eligible if...** - You have been diagnosed with a different bowel condition such as ulcerative colitis, microscopic colitis, or ischemic colitis - You have not tried any prior Crohn's treatment - You have certain infections or other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPlacebo

Matching placebo (identical appearance to MORF-057) administered orally.

DRUGMORF-057

MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Locations(215)

Gastro Care Institute

Lancaster, California, United States

Infinity Clinical Research

San Diego, California, United States

Peak Gastroenterology Associates - Colorado Springs

Colorado Springs, Colorado, United States

Clinical Research of Osceola

Kissimmee, Florida, United States

Bioresearch Partner-Kendale Lakes

Miami, Florida, United States

Endoscopic Research Inc

Orlando, Florida, United States

Tropical Clinical Trials

Palmetto Bay, Florida, United States

Atlanta Gastroenterology Specialists, PC

Atlanta, Georgia, United States

Atlanta Gastroenterology Associates (Part of United Digestive)

Atlanta, Georgia, United States

Tandem Clinical Research

Houma, Louisiana, United States

SSM Health DePaul Hospital- St. Louis

Bridgeton, Missouri, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Cross Creek Medical Clinic

Fayetteville, North Carolina, United States

Peters Medical Research

High Point, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Palmetto Gastroenterology Clinical Research

Summerville, South Carolina, United States

Gastrointestinal Associates of Northeast Tennessee

Johnson City, Tennessee, United States

GI Alliance - Cedar Park

Cedar Park, Texas, United States

North Texas Gastroenterology

Denton, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Prime Clinical Research - Lewisville

Lewisville, Texas, United States

Prime Clinical Research

Mansfield, Texas, United States

Texas Digestive Disease Consultants

San Marcos, Texas, United States

Tyler Research Institute, LLC

Tyler, Texas, United States

Care Access Research - Ogden

Ogden, Utah, United States

Gastroenterology Associates of Central Virginia

Lynchburg, Virginia, United States

Southern Adelaide Local Health Network

Bedford Park, Australia

Royal Brisbane and Women's Hospital

Herston, Australia

IBD SA SA Group of Specialists

Kurralta Park, Australia

The Alfred Hospital

Melbourne, Australia

St. Vincent's Hospital

Melbourne, Australia

Royal Perth Hospital

Perth, Australia

Sir Charles Gairdner Hospital

Perth, Australia

Medical University Hematology

Innsbruck, Austria

Salzburg Regional Hospital

Salzburg, Austria

University Hospital St. Poelten

Sankt Pölten, Austria

Medical University of Vienna

Vienna, Austria

NewData FBHC, NewData Clinical Research

Aracaju, Brazil

Faculdade de Medicina da UNESP

Botucatu, Brazil

Chronos Pesquisa Clínica

Brasília, Brazil

Loema Clinical Research Institute and Consultants SS Ltda- i9 Clinical Research

Campinas, Brazil

Pesquisare

Santo André, Brazil

Clínica Hepatogastro JK

São Paulo, Brazil

"Medical Center Kanev" EOOD

Rousse, Bulgaria

Diagnostic Consultative Center XX - Sofia

Sofia, Bulgaria

Nova Scotia Health Authority

Halifax, Canada

London Health Sciences Centre

London, Canada

London Digestive Disease Institute

London, Canada

Clinique IMD

Montreal, Canada

Diex Recherche Quebec Inc.

Québec, Canada

CaRe Clinic

Red Deer, Canada

Scarborough Center for Inflammatory Bowel Disease

Scarborough, Canada

Mount Sinai Hospital

Toronto, Canada

St Joseph'S Health Centre Toronto

Toronto, Canada

Toronto Digestive Disease Associates, Inc.

Vaughan, Canada

Cardiomet Cequin S.A.S., Research Unit

Armenia, Colombia

Fundación Valle del Lili

Cali, Colombia

Cardiovascular Foundation of Colombia

Floridablanca, Colombia

Corporation for Health Studies "CES"

Medellín, Colombia

Hospital Pablo Tobon Uribe

Medellín, Colombia

Northern University Foundation Hospital

Soledad, Colombia

Poliklinika Borzan

Osijek, Croatia

Specialty hospital Medico Rijeka

Rijeka, Croatia

Virovitica General Hospital

Virovitica, Croatia

General Hospital Zadar

Zadar, Croatia

Poliklinika Solmed

Zagreb, Croatia

SurGal Clinic s.r.o.

Brno, Czechia

Military Hospital Brno,

Brno, Czechia

Clinoxus s.r.o., Outpatient Clinic Budejovicka

Prague, Czechia

Axon Clinical, s.r.o.

Prague, Czechia

East Tallinn Central Hospital

Tallinn, Estonia

West Tallinn Central Hospital

Tallinn, Estonia

Tartu University Hospital, Department of Gastroenterology

Tartu, Estonia

Hospices Civils de Lyon - Lyon Sud

Pierre-Bénite, France

CHRU Nancy Brabois - Hôpital d'Enfants

Vandœuvre-lès-Nancy, France

High Technology Hospital Medcenter LLC

Batumi, Georgia

Emergency Cardiology Center by Academician G. Chapidze LLC

Tbilisi, Georgia

LTD Institute of Clinical Cardiology

Tbilisi, Georgia

LTD Aversi Clinic

Tbilisi, Georgia

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, Georgia

LTD The First Medical Center

Tbilisi, Georgia

Charite - University Hospital Berlin

Berlin, Germany

DRK Clinic Berlin-Koepenick

Berlin, Germany

Medical Care Unit Dachau

Dachau, Germany

Sana Hospital Duisburg

Duisburg, Germany

Agaplesion Markus Hospital

Frankfurt am Main, Germany

University Hospital Halle (Saale)

Halle, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

University Hospital Schleswig-Holstein

Kiel, Germany

University of Leipzig Medical Cent

Leipzig, Germany

GastroPraxis Magdeburg

Magdeburg, Germany

Hospital Ludwig-Maximilians-University Munich, Campus Grosshadern

Munich, Germany

Group Practice Jakobeit

Wipperfürth, Germany

Wolfsburg Hospital Department of internal Medicine

Wolfsburg, Germany

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat

Békéscsaba, Hungary

Semmelweis Medical University

Budapest, Hungary

Markhot Ferenc Oktatókórház

Eger, Hungary

Bugat Pal Hospital Gyongyos

Gyöngyös, Hungary

CLINFAN Szolgáltató Kft

Szekszárd, Hungary

Fejer County St. Gyorgy University Teaching Hospital

Székesfehérvár, Hungary

Navneet Memorial Hospital SUSHRUSHA

Ahmedabad, India

Institute of Medical Sciences & SUM Hospital, Siksha 'O' Anusandhan, Department of Gastroenterology & Hepatology

Bhubaneswar, India

Apollo Cancer Centre

Chennai, India

SMS Medical College Hospital

Jaipur, India

S R Kalla Memorial Gastro and General Hospital

Jaipur, India

Lisie Hospital

Kochi, India

Amrita Institute of Medical Sciences and Research Centre

Kochi, India

Max Super Speciality Hospital

New Delhi, India

Noble Hospital Pvt Ltd

Pune, India

Prime Institute of Digestive Sciences

Rajkot, India

Shree Giriraj Multispeciality Hospital

Rajkot, India

Yashoda Hospital

Secunderabad, India

SIDS Hospital and Research Centre

Surat, India

Samvedna Hospital

Varanasi, India

Policlinico S. Orsola-Malpighi

Bologna, Italy

Poliambulanza Hospital

Brescia, Italy

Universita Degli Studi-Magna Graecia-de Catanzaro

Catanzaro, Italy

Big Metropolitan Hospital Niguarda Regional Health Authority

Milan, Italy

IRCCS San Raffaele

Milan, Italy

Ospedale Sacro Cuore Don G. Calabria

Negrar, Italy

Hospital of Padova

Padova, Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali

Rozzano, Italy

IRCCS Policlinico San Donato

San Donato Milanese, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

University Hospital City of Health and Science of Turin - Hospital Molinette

Turin, Italy

Asahikawa Medical College Hospital

Asahikawa, Japan

Institute of Science Tokyo Hospital

Bunkyō, Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, Japan

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Japan

Kobe University Hospital

Kobe, Japan

Yamanashi Prefectural Central Hospital

Kofu, Japan

Nagasaki University Hospital

Nagasaki, Japan

Nara Prefecture General Medical Center

Nara, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Saga University Hospital

Saga, Japan

Tokitokai Tokito Clinic

Saitama, Japan

Saitama Medical Center

Saitama-Ken, Japan

Toho University Sakura Medical Center

Sakura, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Japan

Tokyo Yamate Medical Center

Tokyo, Japan

Scientific Research Institute of Cardiology and Internal Disease of the Ministry of Health of the Republic of Kazakhstan

Almaty, Kazakhstan

National Research Medical Center

Astana, Kazakhstan

Sana Clinic

Astana, Kazakhstan

Karaganda Medical University

Karaganda, Kazakhstan

Semey Medical University

Semey, Kazakhstan

"Gastromed" Medical Center

Shymkent, Kazakhstan

Diagnostic Center of Shymkent

Shymkent, Kazakhstan

Liepaja Regional Hospital

Liepāja, Latvia

Pauls Stradins Clinical Univeristy Hospital

Riga, Latvia

Applied Neuroscience Research Institute A.C.

Durango, Mexico

Proactive CR México SA de CV

Irapuato, Mexico

Medical Clinical Surgical Center Specialized in Research

Jalisco, Mexico

Key Stone Clinical Trials

Mexico City, Distrito Federal, Mexico

Medical Care and Research SA de CV

Mérida, Mexico

Centro de Investigacion Clinica Chapultepec S.A. de C.V.

Morelia, Mexico

Oaxaca Site Management Organization

Oaxaca City, Mexico

Centro de Estudios Clínicos de Querétaro (CECLIQ)

Querétaro, Mexico

"MEDIS" Medical Center

Bydgoszcz, Poland

Non-public Health Care Center KERmed Medical Centre

Bydgoszcz, Poland

CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

Bydgoszcz, Poland

Synexus Polska Sp. Z o.o. Branch in Czestochowa

Częstochowa, Poland

St. John Paul 2nd Municipal Hospital in Elblag

Elblag, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, Poland

Synexus Polska - Katowicach

Katowice, Poland

"Vita Longa" Non-Public Healthcare Facility, Limited Liability Company

Katowice, Poland

PLEJADY Medical Centre

Krakow, Poland

"Landa" Specialist Doctor's Offices

Krakow, Poland

Oslomed Medical Center

Krakow, Poland

GLOBE Clinical Research Sp. z o.o.

Kłodzko, Poland

Twoja Przychodnia Medical Centre of Opole

Opole, Poland

EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1

Poznan, Poland

Twoja Przychodnia Medical Centre of Poznan

Poznan, Poland

Synexus Polska Sp. z o.o. Branch in Poznan

Poznan, Poland

Endoskopia Sp. z.o.o.

Sopot, Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, Poland

H-T. Medical Center

Tychy, Poland

MDM Healthcare Centre

Warsaw, Poland

Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, Poland

ETG Warszawa

Warsaw, Poland

WSD Medi

Warsaw, Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland

Synexus Polska Sp. z o.o.

Wroclaw, Poland

Medical Centre Oporow

Wroclaw, Poland

"Sfanta Vineri" Medical Center

Bucharest, Romania

Monza Oncology Hospital SRL

Bucharest, Romania

Colentina Clinical Hospital

Bucharest, Romania

Oncohelp Association

Timișoara, Romania

Zvezdara University Medical Center

Belgrade, Serbia

Clinical Center " Dr Dragisa Misovic Dedinje"

Belgrade, Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, Serbia

General Hospital Leskovac

Leskovac, Serbia

Clinical Center of Vojvodina

Novi Sad, Serbia

General Hospital Uzice

Užice, Serbia

General Hospital "Djordje Joanovic"

Zrenjanin, Serbia

Cliniq s.r.o.

Bratislava, Slovakia

ENDOMED s.r.o.

Košice, Slovakia

GASTRO I., s.r.o.

Prešov, Slovakia

Gastro LM s.r.o.

Prešov, Slovakia

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

Ferrol, Spain

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

University and Polytechnic Hospital La Fe

Valencia, Spain

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, Taiwan

National Taiwan University Hospital

Hsinchu, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Far Eastern Memorial Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

Chi Mei Medical Center

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan City, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06226883

Related Trials

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT0718494412 locations

FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

NCT062867095 locations

A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)

NCT0544256798 locations

An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab

NCT031674371 location

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931196 locations