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NCT06226883PHASE2Recruiting

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

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

Start Date

7/18/2024

Completion Date

6/1/2030

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).

Detailed Description

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 3 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Long-Term Extension.

Eligibility Criteria

Age Range: 18 years to 85 years

Key Inclusion Criteria: * Has signs/symptoms of CD for at least 90 days prior to screening * Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points * Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum) * Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase \[JAK\] inhibitors, applicable investigational products) Key Exclusion Criteria: * Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC * Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement * Has had extensive bowel resection (\>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome * Is currently receiving total parenteral nutrition, tube feeding, or a formula diet * Has positive findings on a subjective neurological screening questionnaire * Has a concurrent, clinically significant, serious, unstable comorbidity * Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors * Is currently participating in any other interventional study or has received any investigational therapy within 30 days * Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057 * Unable to attend study visits or comply with study procedures * Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease

Interventions

DRUG

Placebo

DRUG

MORF-057

Interested in This Trial?

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Conditions

Inflammatory Bowel DiseasesCrohn's Disease

Locations

Gastro Care Institute

Lancaster, California 93534

United States

Infinity Clinical Research

San Diego, California 92108

United States

Peak Gastroenterology Associates - Colorado Springs

Colorado Springs, Colorado 80921

United States

Clinical Research of Osceola

Kissimmee, Florida 34741

United States

Bioresearch Partner-Kendale Lakes

Miami, Florida 33155

United States

Endoscopic Research Inc

Orlando, Florida 32803

United States

Tropical Clinical Trials

Palmetto Bay, Florida 33176

United States

Atlanta Gastroenterology Specialists, PC

Atlanta, Georgia 30024

United States

Atlanta Gastroenterology Associates (Part of United Digestive)

Atlanta, Georgia 30342

United States

Tandem Clinical Research

Houma, Louisiana 70360

United States

SSM Health DePaul Hospital- St. Louis

Bridgeton, Missouri 063044

United States

Las Vegas Clinical Trials

North Las Vegas, Nevada 89030

United States

Cross Creek Medical Clinic

Fayetteville, North Carolina 28304

United States

Peters Medical Research

High Point, North Carolina 27260

United States

Wake Research Associates

Raleigh, North Carolina 27612

United States

Palmetto Gastroenterology Clinical Research

Summerville, South Carolina 29486

United States

Gastrointestinal Associates of Northeast Tennessee

Johnson City, Tennessee 44060

United States

GI Alliance - Cedar Park

Cedar Park, Texas 78613

United States

North Texas Gastroenterology

Denton, Texas 76210

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

Prime Clinical Research - Lewisville

Lewisville, Texas 75067

United States

Prime Clinical Research

Mansfield, Texas 76063

United States

Tyler Research Institute, LLC

Tyler, Texas 75701

United States

Care Access Research - Ogden

Ogden, Utah 84403

United States

Gastroenterology Associates of Central Virginia

Lynchburg, Virginia 24502

United States

Southern Adelaide Local Health Network

Bedford Park, 5042

Australia

Royal Brisbane and Women's Hospital

Herston, 4029

Australia

IBD SA SA Group of Specialists

Kurralta Park, 5037

Australia

The Alfred Hospital

Melbourne, 3004

Australia

St. Vincent's Hospital

Melbourne, 3065

Australia

Royal Perth Hospital

Perth, 6000

Australia

Sir Charles Gairdner Hospital

Perth, 6009

Australia

Princess Alexandra Hospital, Metro South Health

Woolloongabba, QLD, 4102

Australia

Medical University Hematology

Innsbruck, 6020

Austria

Salzburg Regional Hospital

Salzburg, 5020

Austria

University Hospital St. Poelten

Sankt Pölten, 3100

Austria

Medical University of Vienna

Vienna, 1090

Austria

University Clinical Centre of the Republic of Srpska

Banja Luka, 78000

Bosnia and Herzegovina

Hospital Plava Medical Group

Tuzla, 75000

Bosnia and Herzegovina

Cantonal Hospital Zenica, Department of Internal Medicine

Zenica, 72000

Bosnia and Herzegovina

NewData FBHC, NewData Clinical Research

Aracaju, 49075-000

Brazil

Faculdade de Medicina da UNESP

Botucatu, 18618-687

Brazil

Chronos Pesquisa Clínica

Brasília, 72145-450

Brazil

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

Campinas, 13093-133

Brazil

Pesquisare

Santo André, 09080-110

Brazil

Clínica Hepatogastro JK

São Paulo, 04543-011

Brazil

"Medical Center Kanev" EOOD

Rousse, 7002

Bulgaria

Diagnostic Consultative Center XX - Sofia

Sofia, 1618

Bulgaria

CaRe Clinic

Alberta, T4P 1K4

Canada

Integrated University Health and Social Services Center of Saguenay-Lac-Saint-Jean

Chicoutimi, G7H 5H6

Canada

Nova Scotia Health Authority

Halifax, B3H 1V7

Canada

Prairie Institute of Liver and Luminal Advanced Research

Lethbridge, T1J 4G9

Canada

London Health Sciences Centre

London, N6A 4L6

Canada

London Digestive Disease Institute

London, N6K 1M6

Canada

Clinique IMD

Montreal, H3H 1E8

Canada

Diex Recherche Quebec Inc.

Québec, G1V 4T3

Canada

Scarborough Center for Inflammatory Bowel Disease

Scarborough, M1B 3V4

Canada

Mount Sinai Hospital

Toronto, M5G 1X5

Canada

St Joseph'S Health Centre Toronto

Toronto, M6R 1B5

Canada

Toronto Digestive Disease Associates, Inc.

Vaughan, L4L 4Y7

Canada

Cardiomet Cequin S.A.S., Research Unit

Armenia, 630004

Colombia

Fundación Valle del Lili

Cali, 760032

Colombia

Cardiovascular Foundation of Colombia

Floridablanca, 681017

Colombia

Corporation for Health Studies "CES"

Medellín, 050012

Colombia

Hospital Pablo Tobon Uribe

Medellín, 050034

Colombia

Northern University Foundation Hospital

Soledad, 083001

Colombia

Poliklinika Borzan

Osijek, 31000

Croatia

Specialty hospital Medico Rijeka

Rijeka, 51000

Croatia

General Hospital Zadar

Zadar, 23000

Croatia

Poliklinika Solmed

Zagreb, 10000

Croatia

SurGal Clinic s.r.o.

Brno, 602 00

Czechia

Military Hospital Brno,

Brno, 615 00

Czechia

Clinoxus s.r.o., Outpatient Clinic Budejovicka

Prague, 140 00

Czechia

Axon Clinical, s.r.o.

Prague, 14000

Czechia

East Tallinn Central Hospital

Tallinn, 10138

Estonia

West Tallinn Central Hospital

Tallinn, 10617

Estonia

Tartu University Hospital, Department of Gastroenterology

Tartu, 50406

Estonia

Hospices Civils de Lyon - Lyon Sud

Pierre-Bénite, 69310

France

CHRU Nancy Brabois - Hôpital d'Enfants

Vandœuvre-lès-Nancy, 54500

France

High Technology Hospital Medcenter LLC

Batumi, 6010

Georgia

Emergency Cardiology Center by Academician G. Chapidze LLC

Tbilisi, 0159

Georgia

LTD Institute of Clinical Cardiology

Tbilisi, 0159

Georgia

LTD Aversi Clinic

Tbilisi, 0160

Georgia

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, 0178

Georgia

LTD The First Medical Center

Tbilisi, 0180

Georgia

Charite - University Hospital Berlin

Berlin, 10117

Germany

DRK Clinic Berlin-Koepenick

Berlin, 12559

Germany

Medical Care Unit Dachau

Dachau, 85221

Germany

Sana Hospital Duisburg

Duisburg, 53119

Germany

Agaplesion Markus Hospital

Frankfurt am Main, 60431

Germany

University Hospital Halle (Saale)

Halle, 06120

Germany

Universitätsklinikum Heidelberg

Heidelberg, 69120

Germany

University Hospital Schleswig-Holstein

Kiel, 24105

Germany

University of Leipzig Medical Cent

Leipzig, 04103

Germany

GastroPraxis Magdeburg

Magdeburg, 110 39104

Germany

Hospital Ludwig-Maximilians-University Munich, Campus Grosshadern

Munich, 81377

Germany

Group Practice Jakobeit

Wipperfürth, 51688

Germany

Wolfsburg Hospital Department of internal Medicine

Wolfsburg, 38440

Germany

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

Békéscsaba, 5600

Hungary

Semmelweis Medical University

Budapest, 1083

Hungary

Markhot Ferenc Oktatókórház

Eger, 3300

Hungary

Bugat Pal Hospital Gyongyos

Gyöngyös, 3200

Hungary

CLINFAN Szolgáltató Kft

Szekszárd, 7100

Hungary

Fejer County St. Gyorgy University Teaching Hospital

Székesfehérvár, H-8000

Hungary

Navneet Memorial Hospital SUSHRUSHA

Ahmedabad, 380009

India

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

Bhubaneswar, 751003

India

Apollo Cancer Centre

Chennai, 600035

India

VGM Hospital

Coimbatore, 641005

India

SMS Medical College Hospital

Jaipur, 302004

India

S R Kalla Memorial Gastro and General Hospital

Jaipur, 302006

India

Lisie Hospital

Kochi, 682017

India

Amrita Institute of Medical Sciences and Research Centre

Kochi, 682041

India

Dayanand Medical College and Hospital

Ludhiana, 141001

India

Max Super Speciality Hospital

New Delhi, 110 017

India

Noble Hospital Pvt Ltd

Pune, 411013

India

Prime Institute of Digestive Sciences

Rajkot, 360001

India

Shree Giriraj Multispeciality Hospital

Rajkot, 360005

India

Yashoda Hospital

Secunderabad, 500003

India

SIDS Hospital and Research Centre

Surat, 395002

India

Samvedna Hospital

Varanasi, 221005

India

Policlinico S. Orsola-Malpighi

Bologna, 40138

Italy

Poliambulanza Hospital

Brescia, 25124

Italy

Universita Degli Studi-Magna Graecia-de Catanzaro

Catanzaro, 88100

Italy

Big Metropolitan Hospital Niguarda Regional Health Authority

Milan, 20162

Italy

IRCCS San Raffaele

Milan, 20132

Italy

Ospedale Sacro Cuore Don G. Calabria

Negrar, 37024

Italy

Hospital of Padova

Padova, 35128

Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, 00152

Italy

IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali

Rozzano, 20089

Italy

IRCCS Policlinico San Donato

San Donato Milanese, 20097

Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013

Italy

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

Turin, 10126

Italy

Asahikawa Medical College Hospital

Asahikawa, 078-8510

Japan

Institute of Science Tokyo Hospital

Bunkyō, 113-8519

Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, 818-8502

Japan

Kokikai Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, 277-0871

Japan

Kobe University Hospital

Kobe, 650-0017

Japan

Yamanashi Prefectural Central Hospital

Kofu, 400-0027

Japan

Nagasaki University Hospital

Nagasaki, 852-8501

Japan

Nara Prefecture General Medical Center

Nara, 630-8054

Japan

Osaka Metropolitan University Hospital

Osaka, 5450051

Japan

Saga University Hospital

Saga, 849-8501

Japan

Tokitokai Tokito Clinic

Saitama, 336-0963

Japan

Saitama Medical Center

Saitama-Ken, 350 8550

Japan

Toho University Sakura Medical Center

Sakura, 285-8741

Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, 065-0033

Japan

Tokyo Yamate Medical Center

Tokyo, 169-0073

Japan

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

Almaty, 050000

Kazakhstan

National Research Medical Center

Astana, Z00P6K6

Kazakhstan

Sana Clinic

Astana, Z00P6K6

Kazakhstan

Karaganda Medical University

Karaganda, 100000

Kazakhstan

Semey Medical University

Semey, 071400

Kazakhstan

"Gastromed" Medical Center

Shymkent, 160005

Kazakhstan

Diagnostic Center of Shymkent

Shymkent, 160021

Kazakhstan

Liepaja Regional Hospital

Liepāja, LV-3414

Latvia

Pauls Stradins Clinical Univeristy Hospital

Riga, LV-1002

Latvia

Applied Neuroscience Research Institute A.C.

Durango, 34000

Mexico

Proactive CR México SA de CV

Irapuato, 36520

Mexico

Medical Clinical Surgical Center Specialized in Research

Jalisco, 45640

Mexico

Key Stone Clinical Trials

Mexico City, Distrito Federal, 06100

Mexico

Medical Care and Research SA de CV

Mérida, 97070

Mexico

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

Morelia, 58260

Mexico

Oaxaca Site Management Organization

Oaxaca City, 68000

Mexico

Centro de Estudios Clínicos de Querétaro (CECLIQ)

Querétaro, 76000

Mexico

PMSI "Timofei Mosneaga" Republican Clinical Hospital, Outpatient Department

Chisinau, MD-2025

Moldova

PMSI "Timofei Mosneaga" Republican Clinical Hospital, Therapy Department, Division of Gastroenterology

Chisinau, MD-2025

Moldova

"Sfanta Treime" Municipal Clinical Hospital

Chisinau, MD-2068

Moldova

Rtl Sm Srl

Chisinau, MD2072

Moldova

"MEDIS" Medical Center

Bydgoszcz, 85-229

Poland

Non-public Health Care Center KERmed Medical Centre

Bydgoszcz, 85-231

Poland

CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska

Bydgoszcz, 85-794

Poland

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

Częstochowa, 42-202

Poland

St. John Paul 2nd Municipal Hospital in Elblag

Elblag, 82-300

Poland

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

Gdansk, 80-382

Poland

Synexus Polska - Katowicach

Katowice, 40-040

Poland

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

Katowice, 40-748

Poland

PLEJADY Medical Centre

Krakow, 30-363

Poland

"Landa" Specialist Doctor's Offices

Krakow, 31-156

Poland

Oslomed Medical Center

Krakow, 31-228

Poland

GLOBE Clinical Research Sp. z o.o.

Kłodzko, 57-300

Poland

Twoja Przychodnia Medical Centre of Opole

Opole, 45-819

Poland

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

Poznan, 60-309

Poland

Twoja Przychodnia Medical Centre of Poznan

Poznan, 60-324

Poland

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

Poznan, 81-537

Poland

Endoskopia Sp. z.o.o.

Sopot, 81-756

Poland

Twoja Przychodnia-Szczecinskie Centrum Medyczne

Szczecin, 71-434

Poland

H-T. Medical Center

Tychy, 43-100

Poland

MDM Healthcare Centre

Warsaw, 00-189

Poland

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

Warsaw, 02-672

Poland

ETG Warszawa

Warsaw, 02-677

Poland

WSD Medi

Warsaw, 02-786

Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 04-501

Poland

Synexus Polska Sp. z o.o.

Wroclaw, 50-381

Poland

Medical Centre Oporow

Wroclaw, 52-416

Poland

"Sfanta Vineri" Medical Center

Bucharest, 011273

Romania

Monza Oncology Hospital SRL

Bucharest, 013823

Romania

Colentina Clinical Hospital

Bucharest, 020125

Romania

Oncohelp Association

Timișoara, 300239

Romania

Zvezdara University Medical Center

Belgrade, 11 000

Serbia

Clinical Center " Dr Dragisa Misovic Dedinje"

Belgrade, 11000

Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11000

Serbia

General Hospital Leskovac

Leskovac, 16000

Serbia

General Hospital Uzice

Užice, 31000

Serbia

General Hospital "Djordje Joanovic"

Zrenjanin, 23000

Serbia

Cliniq s.r.o.

Bratislava, 811 09

Slovakia

ENDOMED s.r.o.

Košice, 04013

Slovakia

GASTRO I., s.r.o.

Prešov, 08001

Slovakia

Gastro LM s.r.o.

Prešov, 08001

Slovakia

Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval

Ferrol, 15405

Spain

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, 25198

Spain

Hospital Universitario La Paz

Madrid, 28046

Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, 28222

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

University and Polytechnic Hospital La Fe

Valencia, 46026

Spain

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, 60002

Taiwan

National Taiwan University Hospital

Hsinchu, 302

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807377

Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362

Taiwan

Far Eastern Memorial Hospital

New Taipei City, 22060

Taiwan

China Medical University Hospital

Taichung, 404327

Taiwan

Taichung Veterans General Hospital

Taichung, 407219

Taiwan

Chi Mei Medical Center

Tainan, 71004

Taiwan

National Taiwan University Hospital

Taipei, 100225

Taiwan

Mackay Memorial Hospital

Taipei, 10449

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan City, 333

Taiwan