TrialPath
← Back to searchRecruiting

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

NCT06226883 · Eli Lilly and Company
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
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)
About this study
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
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
Study design
Enrollment target: 385 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-07-18
Estimated completion: 2030-06
Last updated: 2026-04-17
Interventions
Drug: PlaceboDrug: MORF-057
Primary outcomes
  • Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD) (Baseline to Week 14)
Sponsor
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · study_director, Eli Lilly and Company
All locations (215)
Gastro Care InstituteRecruiting
Lancaster, California, United States
Infinity Clinical ResearchNot Yet Recruiting
San Diego, California, United States
Peak Gastroenterology Associates - Colorado SpringsNot Yet Recruiting
Colorado Springs, Colorado, United States
Clinical Research of OsceolaNot Yet Recruiting
Kissimmee, Florida, United States
Bioresearch Partner-Kendale LakesNot Yet Recruiting
Miami, Florida, United States
Endoscopic Research IncNot Yet Recruiting
Orlando, Florida, United States
Tropical Clinical TrialsNot Yet Recruiting
Palmetto Bay, Florida, United States
Atlanta Gastroenterology Specialists, PCNot Yet Recruiting
Atlanta, Georgia, United States
Atlanta Gastroenterology Associates (Part of United Digestive)Not Yet Recruiting
Atlanta, Georgia, United States
Tandem Clinical ResearchNot Yet Recruiting
Houma, Louisiana, United States
SSM Health DePaul Hospital- St. LouisNot Yet Recruiting
Bridgeton, Missouri, United States
Las Vegas Clinical TrialsNot Yet Recruiting
North Las Vegas, Nevada, United States
Cross Creek Medical ClinicNot Yet Recruiting
Fayetteville, North Carolina, United States
Peters Medical ResearchNot Yet Recruiting
High Point, North Carolina, United States
Wake Research AssociatesRecruiting
Raleigh, North Carolina, United States
Palmetto Gastroenterology Clinical ResearchRecruiting
Summerville, South Carolina, United States
Gastrointestinal Associates of Northeast TennesseeRecruiting
Johnson City, Tennessee, United States
GI Alliance - Cedar ParkRecruiting
Cedar Park, Texas, United States
North Texas GastroenterologyNot Yet Recruiting
Denton, Texas, United States
The University of Texas Health Science Center at HoustonRecruiting
Houston, Texas, United States
Prime Clinical Research - LewisvilleNot Yet Recruiting
Lewisville, Texas, United States
Prime Clinical ResearchNot Yet Recruiting
Mansfield, Texas, United States
Texas Digestive Disease ConsultantsRecruiting
San Marcos, Texas, United States
Tyler Research Institute, LLCRecruiting
Tyler, Texas, United States
Care Access Research - OgdenRecruiting
Ogden, Utah, United States
Gastroenterology Associates of Central VirginiaRecruiting
Lynchburg, Virginia, United States
Southern Adelaide Local Health NetworkNot Yet Recruiting
Bedford Park, Australia
Royal Brisbane and Women's HospitalNot Yet Recruiting
Herston, Australia
IBD SA SA Group of SpecialistsNot Yet Recruiting
Kurralta Park, Australia
The Alfred HospitalNot Yet Recruiting
Melbourne, Australia
St. Vincent's HospitalNot Yet Recruiting
Melbourne, Australia
Royal Perth HospitalNot Yet Recruiting
Perth, Australia
Sir Charles Gairdner HospitalNot Yet Recruiting
Perth, Australia
Medical University HematologyRecruiting
Innsbruck, Austria
Salzburg Regional HospitalRecruiting
Salzburg, Austria
University Hospital St. PoeltenRecruiting
Sankt Pölten, Austria
Medical University of ViennaRecruiting
Vienna, Austria
NewData FBHC, NewData Clinical ResearchNot Yet Recruiting
Aracaju, Brazil
Faculdade de Medicina da UNESPNot Yet Recruiting
Botucatu, Brazil
Chronos Pesquisa ClínicaRecruiting
Brasília, Brazil
Loema Clinical Research Institute and Consultants SS Ltda- i9 Clinical ResearchNot Yet Recruiting
Campinas, Brazil
PesquisareRecruiting
Santo André, Brazil
Clínica Hepatogastro JKRecruiting
São Paulo, Brazil
"Medical Center Kanev" EOODNot Yet Recruiting
Rousse, Bulgaria
Diagnostic Consultative Center XX - SofiaNot Yet Recruiting
Sofia, Bulgaria
Nova Scotia Health AuthorityRecruiting
Halifax, Canada
London Health Sciences CentreRecruiting
London, Canada
London Digestive Disease InstituteNot Yet Recruiting
London, Canada
Clinique IMDNot Yet Recruiting
Montreal, Canada
Diex Recherche Quebec Inc.Recruiting
Québec, Canada
CaRe ClinicNot Yet Recruiting
Red Deer, Canada
Scarborough Center for Inflammatory Bowel DiseaseNot Yet Recruiting
Scarborough, Canada
Mount Sinai HospitalRecruiting
Toronto, Canada
St Joseph'S Health Centre TorontoRecruiting
Toronto, Canada
Toronto Digestive Disease Associates, Inc.Recruiting
Vaughan, Canada
Cardiomet Cequin S.A.S., Research UnitRecruiting
Armenia, Colombia
Fundación Valle del LiliRecruiting
Cali, Colombia
Cardiovascular Foundation of ColombiaRecruiting
Floridablanca, Colombia
Corporation for Health Studies "CES"Recruiting
Medellín, Colombia
Hospital Pablo Tobon UribeRecruiting
Medellín, Colombia
Northern University Foundation HospitalRecruiting
Soledad, Colombia
Poliklinika BorzanRecruiting
Osijek, Croatia
Specialty hospital Medico RijekaRecruiting
Rijeka, Croatia
Virovitica General HospitalRecruiting
Virovitica, Croatia
General Hospital ZadarRecruiting
Zadar, Croatia
Poliklinika SolmedRecruiting
Zagreb, Croatia
SurGal Clinic s.r.o.Recruiting
Brno, Czechia
Military Hospital Brno,Recruiting
Brno, Czechia
Clinoxus s.r.o., Outpatient Clinic BudejovickaRecruiting
Prague, Czechia
Axon Clinical, s.r.o.Recruiting
Prague, Czechia
East Tallinn Central HospitalNot Yet Recruiting
Tallinn, Estonia
West Tallinn Central HospitalNot Yet Recruiting
Tallinn, Estonia
Tartu University Hospital, Department of GastroenterologyNot Yet Recruiting
Tartu, Estonia
Hospices Civils de Lyon - Lyon SudRecruiting
Pierre-Bénite, France
CHRU Nancy Brabois - Hôpital d'EnfantsRecruiting
Vandœuvre-lès-Nancy, France
High Technology Hospital Medcenter LLCRecruiting
Batumi, Georgia
Emergency Cardiology Center by Academician G. Chapidze LLCRecruiting
Tbilisi, Georgia
LTD Institute of Clinical CardiologyRecruiting
Tbilisi, Georgia
LTD Aversi ClinicRecruiting
Tbilisi, Georgia
LEPL The First University Clinic of Tbilisi State Medical UniversityRecruiting
Tbilisi, Georgia
LTD The First Medical CenterRecruiting
Tbilisi, Georgia
Charite - University Hospital BerlinRecruiting
Berlin, Germany
DRK Clinic Berlin-KoepenickRecruiting
Berlin, Germany
Medical Care Unit DachauRecruiting
Dachau, Germany
Sana Hospital DuisburgRecruiting
Duisburg, Germany
Agaplesion Markus HospitalNot Yet Recruiting
Frankfurt am Main, Germany
University Hospital Halle (Saale)Recruiting
Halle, Germany
Universitätsklinikum HeidelbergRecruiting
Heidelberg, Germany
University Hospital Schleswig-HolsteinRecruiting
Kiel, Germany
University of Leipzig Medical CentNot Yet Recruiting
Leipzig, Germany
GastroPraxis MagdeburgNot Yet Recruiting
Magdeburg, Germany
Hospital Ludwig-Maximilians-University Munich, Campus GrosshadernNot Yet Recruiting
Munich, Germany
Group Practice JakobeitRecruiting
Wipperfürth, Germany
Wolfsburg Hospital Department of internal MedicineNot Yet Recruiting
Wolfsburg, Germany
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. BelgyogyaszatRecruiting
Békéscsaba, Hungary
Semmelweis Medical UniversityRecruiting
Budapest, Hungary
Markhot Ferenc OktatókórházRecruiting
Eger, Hungary
Bugat Pal Hospital GyongyosRecruiting
Gyöngyös, Hungary
CLINFAN Szolgáltató KftRecruiting
Szekszárd, Hungary
Fejer County St. Gyorgy University Teaching HospitalRecruiting
Székesfehérvár, Hungary
Navneet Memorial Hospital SUSHRUSHARecruiting
Ahmedabad, India
Institute of Medical Sciences & SUM Hospital, Siksha 'O' Anusandhan, Department of Gastroenterology & HepatologyNot Yet Recruiting
Bhubaneswar, India
Apollo Cancer CentreRecruiting
Chennai, India
SMS Medical College HospitalRecruiting
Jaipur, India
S R Kalla Memorial Gastro and General HospitalRecruiting
Jaipur, India
Lisie HospitalRecruiting
Kochi, India
Amrita Institute of Medical Sciences and Research CentreRecruiting
Kochi, India
Max Super Speciality HospitalRecruiting
New Delhi, India
Noble Hospital Pvt LtdRecruiting
Pune, India
Prime Institute of Digestive SciencesRecruiting
Rajkot, India
Shree Giriraj Multispeciality HospitalRecruiting
Rajkot, India
Yashoda HospitalRecruiting
Secunderabad, India
SIDS Hospital and Research CentreRecruiting
Surat, India
Samvedna HospitalRecruiting
Varanasi, India
Policlinico S. Orsola-MalpighiRecruiting
Bologna, Italy
Poliambulanza HospitalNot Yet Recruiting
Brescia, Italy
Universita Degli Studi-Magna Graecia-de CatanzaroNot Yet Recruiting
Catanzaro, Italy
Big Metropolitan Hospital Niguarda Regional Health AuthorityRecruiting
Milan, Italy
IRCCS San RaffaeleRecruiting
Milan, Italy
Ospedale Sacro Cuore Don G. CalabriaRecruiting
Negrar, Italy
Hospital of PadovaNot Yet Recruiting
Padova, Italy
Azienda Ospedaliera San Camillo ForlaniniRecruiting
Roma, Italy
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie IntestinaliRecruiting
Rozzano, Italy
IRCCS Policlinico San DonatoRecruiting
San Donato Milanese, Italy
IRCCS Ospedale Casa Sollievo della SofferenzaRecruiting
San Giovanni Rotondo, Italy
University Hospital City of Health and Science of Turin - Hospital MolinetteNot Yet Recruiting
Turin, Italy
Asahikawa Medical College HospitalRecruiting
Asahikawa, Japan
Institute of Science Tokyo HospitalRecruiting
Bunkyō, Japan
Fukuoka University Chikushi HospitalRecruiting
Chikushino-shi, Japan
Kokikai Tsujinaka Hospital KashiwanohaRecruiting
Kashiwa-shi, Japan
Kobe University HospitalRecruiting
Kobe, Japan
Yamanashi Prefectural Central HospitalRecruiting
Kofu, Japan
Nagasaki University HospitalRecruiting
Nagasaki, Japan
Nara Prefecture General Medical CenterRecruiting
Nara, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Saga University HospitalRecruiting
Saga, Japan
Tokitokai Tokito ClinicRecruiting
Saitama, Japan
Saitama Medical CenterRecruiting
Saitama-Ken, Japan
Toho University Sakura Medical CenterRecruiting
Sakura, Japan
Sapporo Higashi Tokushukai HospitalRecruiting
Sapporo, Japan
Tokyo Yamate Medical CenterRecruiting
Tokyo, Japan
Scientific Research Institute of Cardiology and Internal Disease of the Ministry of Health of the Republic of KazakhstanRecruiting
Almaty, Kazakhstan
National Research Medical CenterRecruiting
Astana, Kazakhstan
Sana ClinicRecruiting
Astana, Kazakhstan
Karaganda Medical UniversityRecruiting
Karaganda, Kazakhstan
Semey Medical UniversityRecruiting
Semey, Kazakhstan
"Gastromed" Medical CenterRecruiting
Shymkent, Kazakhstan
Diagnostic Center of ShymkentRecruiting
Shymkent, Kazakhstan
Liepaja Regional HospitalRecruiting
Liepāja, Latvia
Pauls Stradins Clinical Univeristy HospitalRecruiting
Riga, Latvia
Applied Neuroscience Research Institute A.C.Recruiting
Durango, Mexico
Proactive CR México SA de CVRecruiting
Irapuato, Mexico
Medical Clinical Surgical Center Specialized in ResearchRecruiting
Jalisco, Mexico
Key Stone Clinical TrialsRecruiting
Mexico City, Distrito Federal, Mexico
Medical Care and Research SA de CVRecruiting
Mérida, Mexico
Centro de Investigacion Clinica Chapultepec S.A. de C.V.Recruiting
Morelia, Mexico
Oaxaca Site Management OrganizationRecruiting
Oaxaca City, Mexico
Centro de Estudios Clínicos de Querétaro (CECLIQ)Recruiting
Querétaro, Mexico
"MEDIS" Medical CenterRecruiting
Bydgoszcz, Poland
Non-public Health Care Center KERmed Medical CentreRecruiting
Bydgoszcz, Poland
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata TrzaskaRecruiting
Bydgoszcz, Poland
Synexus Polska Sp. Z o.o. Branch in CzestochowaRecruiting
Częstochowa, Poland
St. John Paul 2nd Municipal Hospital in ElblagRecruiting
Elblag, Poland
AES - DRS - Synexus Polska Sp. z o.o. Oddzial w GdanskuRecruiting
Gdansk, Poland
Synexus Polska - KatowicachRecruiting
Katowice, Poland
"Vita Longa" Non-Public Healthcare Facility, Limited Liability CompanyRecruiting
Katowice, Poland
PLEJADY Medical CentreRecruiting
Krakow, Poland
"Landa" Specialist Doctor's OfficesRecruiting
Krakow, Poland
Oslomed Medical CenterNot Yet Recruiting
Krakow, Poland
GLOBE Clinical Research Sp. z o.o.Not Yet Recruiting
Kłodzko, Poland
Twoja Przychodnia Medical Centre of OpoleRecruiting
Opole, Poland
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1Recruiting
Poznan, Poland
Twoja Przychodnia Medical Centre of PoznanRecruiting
Poznan, Poland
Synexus Polska Sp. z o.o. Branch in PoznanRecruiting
Poznan, Poland
Endoskopia Sp. z.o.o.Recruiting
Sopot, Poland
Twoja Przychodnia-Szczecinskie Centrum MedyczneRecruiting
Szczecin, Poland
H-T. Medical CenterRecruiting
Tychy, Poland
MDM Healthcare CentreRecruiting
Warsaw, Poland
Synexus Polska Sp. z o.o. Oddzial w WarszawieRecruiting
Warsaw, Poland
ETG WarszawaNot Yet Recruiting
Warsaw, Poland
WSD MediRecruiting
Warsaw, Poland
WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Synexus Polska Sp. z o.o.Recruiting
Wroclaw, Poland
Medical Centre OporowRecruiting
Wroclaw, Poland
"Sfanta Vineri" Medical CenterRecruiting
Bucharest, Romania
Monza Oncology Hospital SRLRecruiting
Bucharest, Romania
Colentina Clinical HospitalRecruiting
Bucharest, Romania
Oncohelp AssociationRecruiting
Timișoara, Romania
Zvezdara University Medical CenterRecruiting
Belgrade, Serbia
Clinical Center " Dr Dragisa Misovic Dedinje"Recruiting
Belgrade, Serbia
Clinical Hospital Center Bezanijska KosaRecruiting
Belgrade, Serbia
General Hospital LeskovacRecruiting
Leskovac, Serbia
Clinical Center of VojvodinaRecruiting
Novi Sad, Serbia
General Hospital UziceRecruiting
Užice, Serbia
General Hospital "Djordje Joanovic"Recruiting
Zrenjanin, Serbia
Cliniq s.r.o.Recruiting
Bratislava, Slovakia
ENDOMED s.r.o.Recruiting
Košice, Slovakia
GASTRO I., s.r.o.Recruiting
Prešov, Slovakia
Gastro LM s.r.o.Recruiting
Prešov, Slovakia
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital NavalRecruiting
Ferrol, Spain
Hospital Universitario Arnau de Vilanova de LleidaRecruiting
Lleida, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Majadahonda, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
University and Polytechnic Hospital La FeRecruiting
Valencia, Spain
Ditmanson Medical Foundation Chia-Yi Christian HospitalNot Yet Recruiting
Chiayi City, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Hsinchu, Taiwan
Kaohsiung Medical University Chung-Ho Memorial HospitalNot Yet Recruiting
Kaohsiung City, Taiwan
Far Eastern Memorial HospitalNot Yet Recruiting
New Taipei City, Taiwan
China Medical University HospitalNot Yet Recruiting
Taichung, Taiwan
Taichung Veterans General HospitalNot Yet Recruiting
Taichung, Taiwan
Chi Mei Medical CenterNot Yet Recruiting
Tainan, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Mackay Memorial HospitalNot Yet Recruiting
Taipei, Taiwan
Chang Gung Memorial Hospital - LinkouNot Yet Recruiting
Taoyuan, Taiwan
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease · TrialPath