A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Launched by MORPHIC THERAPEUTIC, INC. (A WHOLLY OWNED SUBSIDIARY OF ELI LILLY AND COMPANY) · Jan 17, 2024
Trial Information
Current as of August 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called MORF-057 to see how well it works and how safe it is for adults with moderately to severely active Crohn's disease, which is a condition that causes inflammation in the digestive tract. The study involves comparing the effects of MORF-057 with a placebo (a treatment that does not contain the active drug) to understand its potential benefits. The trial is currently recruiting participants aged 18 to 80 who have been experiencing symptoms of Crohn's disease for at least three months and have had limited success with other treatments.
To participate, individuals need to have a specific score that shows their Crohn's disease is active, and they should have tried at least one other treatment without getting better. Participants will need to attend regular study visits and follow certain guidelines throughout the trial. It's important for those interested to know that they cannot have certain other health conditions or have previously received specific treatments that could affect their eligibility. This study aims to help improve treatment options for Crohn's disease, and participants will play a vital role in advancing our understanding of this condition.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Has signs/symptoms of CD for at least 3 months 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)
- • Agrees to abide by the study guidelines and requirements
- • Capable of giving signed informed consent
- 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
About Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary Of Eli Lilly And Company)
Morphic Therapeutic, Inc., a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage biotechnology firm focused on the discovery and development of innovative small-molecule therapeutics targeting integrins. Leveraging proprietary chemistry and biology platforms, Morphic aims to address unmet medical needs in areas such as fibrosis, oncology, and autoimmune diseases, advancing novel treatments through rigorous clinical development.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Montreal, Quebec, Canada
Houston, Texas, United States
Raleigh, North Carolina, United States
Bologna, , Italy
Lleida, , Spain
Bucharest, , Romania
Heidelberg, , Germany
Budapest, , Hungary
Vienna, , Austria
Sevilla, , Spain
Milano, , Italy
Calgary, Alberta, Canada
Kragujevac, , Serbia
Vaughan, Ontario, Canada
Kiel, , Germany
Belgrade, , Serbia
Jaipur, Rajasthan, India
Majadahonda, , Spain
Kochi, Kerala, India
Novi Sad, , Serbia
Sopot, , Poland
Tyler, Texas, United States
Pune, , India
Uzice, , Serbia
Liepaja, , Latvia
Roma, Lazio, Italy
San Giovanni Rotondo, Fg, Italy
Szczecin, , Poland
Rajkot, Gujarat, India
Zadar, , Croatia
Tbilisi, , Georgia
Dachau, , Germany
Salzburg, , Austria
Ulm, Baden Wuerttemberg, Germany
Shreveport, Louisiana, United States
Zrenjanin, , Serbia
Tbilisi, , Georgia
Valencia, , Spain
Leskovac, , Serbia
Halle, , Germany
Elblag, , Poland
Lynchburg, Virginia, United States
San Donato Milanese, Milano, Italy
Vandoeuvre Les Nancy, , France
Secunderabad, Andhra Pradesh, India
Bekescsaba, , Hungary
Szekszard, , Hungary
Presova, , Slovakia
Santo Andre, Sao Paulo, Brazil
Belgrade, , Serbia
Presov, , Slovakia
Bratislava, , Slovakia
Lancaster, California, United States
Cali, Valle Del Cauca, Colombia
Houston, Texas, United States
Berlin, , Germany
Madrid, , Spain
Valencia, , Spain
Ogden, Utah, United States
Kosice, , Slovakia
Bologna, , Italy
Wroclaw, , Poland
Karaganda, , Kazakhstan
Riga, , Latvia
Kissimmee, Florida, United States
Quebec, , Canada
Bydgoszcz, , Poland
Elblag, , Poland
Katowice, , Poland
Tychy, , Poland
Brasília, , Brazil
Lancaster, California, United States
Lynchburg, Virginia, United States
St. Poelten, , Austria
Cedar Park, Texas, United States
Tbilisi, , Georgia
Tbilisi, , Georgia
Ulm, , Germany
Milan, , Italy
Sopot, , Poland
Brno, , Czechia
Berlin, , Germany
São Paulo, , Brazil
Saint Etienne Cedex 02, , France
Eger, Heves, Hungary
Rozzano, , Italy
Zagreb, Grad Zagreb, Croatia
Warszawa, Mazowieckie, Poland
Warsaw, Mazowieckie, Poland
Opole, , Poland
Belgrade, , Serbia
Tyler, Texas, United States
Semey, , Kazakhstan
Shreveport, Louisiana, United States
Summerville, South Carolina, United States
Johnson City, Tennessee, United States
Batumi, , Georgia
Tbilisi, , Georgia
Ogden, Utah, United States
Warsaw, , Poland
Vienna, , Austria
Prague, , Czechia
Saint Priest En Jarez, , France
Heidelberg, Baden Wuerttemberg, Germany
Gyongyos, , Hungary
Szekesfehervar, , Hungary
Jaipur, Rajasthan, India
Milan, , Italy
San Giovanni Rotondo, , Italy
Riga, , Latvia
Elbląg, , Poland
Opole, , Poland
Poznan, , Poland
Szczecin, , Poland
Warsaw, , Poland
Zrenjanin, , Serbia
Bratislava, , Slovakia
Raleigh, North Carolina, United States
Tbilisi, , Georgia
Gdańsk, Pomorskie, Poland
Osijek, , Croatia
Zadar, , Croatia
Dachau, , Germany
Duisburg, , Germany
Budapest, , Hungary
Szekszárd, , Hungary
Rozzano, , Italy
Wroclaw, , Poland
Bucharest, , Romania
Kosice, , Slovakia
Presov, , Slovakia
Lleida, , Spain
Madrid, , Spain
Seville, , Spain
Innsbruck, , Austria
Brno, , Czechia
Negrar, , Italy
Czestochowa, , Poland
Warsaw, , Poland
Timişoara, , Romania
Belgrade, , Serbia
Kiel, , Germany
Kraków, , Poland
Calgary, , Canada
St. Poelten, , Austria
Virovitica, , Croatia
Pierre Benite, , France
Wipperfurth, , Germany
Gdansk, , Poland
Katowice, , Poland
Constanta, , Romania
Brno, , Czech Republic
Prague, , Czech Republic
Leskovac, , Serbia
Novi Sad, , Serbia
Southlake, Texas, United States
Montreal, , Canada
Toronto, , Canada
Vandoeuvre Les Nancy, , France
Halifax, , Canada
Eger, , Hungary
San Donato Milanese, , Italy
Bydgoszcz, , Poland
Kragujevac, , Serbia
Uzice, , Serbia
A Coruna, , Spain
Leon, , Spain
Medellin, , Colombia
Zagreb, , Croatia
Halifax, , Canada
Medellin, Antioquia, Colombia
Halle, Saxony Anhalt, Germany
Barranquilla, , Colombia
Rijeka, , Croatia
Udine, , Italy
London, , Canada
Karaganda, , Kazakhstan
Almaty, , Kazakhstan
Durango, , Mexico
Armenia, , Colombia
Cali, , Colombia
Medellin, , Colombia
Soledad, , Colombia
Ahmedabad, , India
Jaipur, , India
Rajkot, , India
Secunderabad, , India
Shymkent, , Kazakhstan
Gujarat, , India
Astana, , Kazakhstan
Summerville, South Carolina, United States
Floridablanca, , Colombia
Bekescsaba, , Hungary
Rājkot, , India
Semey, , Kazakhstan
Osijek, , Croatia
Poznan, , Poland
Sao Paulo, , Brazil
Toronto, Ontario, Canada
Woodbridge, Ontario, Canada
Kochi, Kerala, India
Pune, Maharashtra, India
Varanasi, Uttar Pradesh, India
Chennai, Tamil Nadu, India
Rome, , Italy
Queretaro, , Mexico
Santo Andre, Sao Paulo, , Brazil
Oaxaca, , Mexico
Brasilia, , Brazil
Santo Andre, , Brazil
Ferrol, , Spain
Tbilisi, , Georgia
Bydgoszcz, , Poland
Bydgoszcz, , Poland
Katowice, , Poland
Wroclaw, , Poland
Salzburg, , Austria
Prague, , Czechia
Szekesfehervar, , Hungary
Jaipur, Sardar Patel Marg, India
Tychy, , Poland
Johnson City, Tennessee, United States
Cedar Park, Texas, United States
San Marcos, Texas, United States
Innsbruck, Tyrol, Austria
Chicago, Il, Canada
Toronto, Ontario, Canada
London, , Canada
Medellín, Antioquia, Colombia
Armenia, , Colombia
Floridablanca, , Colombia
Medellin, , Colombia
Soledad, , Colombia
Rijeka, , Croatia
Virovitica, , Croatia
Brno, , Czechia
Praha 4, , Czechia
Pierre Benite, , France
Batumi, , Georgia
Berlin, , Germany
Berlin, , Germany
Duisburg, , Germany
Wipperfuerth, , Germany
Gyongyos, , Hungary
Chennai, Tamil Nadu, India
Ahmedabad, , India
Rajkot, , India
Negrar, Verona, Italy
Udine, , Italy
Almaty, , Kazakhstan
Astana, , Kazakhstan
Astana, , Kazakhstan
Shymkent, , Kazakhstan
Shymkent, , Kazakhstan
Queretaro, , Mexico
Durango, , Mexico
Bydgoszcz, , Poland
Czestochowa, , Poland
Krakow, , Poland
Krakow, , Poland
Poznan, , Poland
Warsaw, , Poland
Katowice, , Poland
Bucharest, , Romania
Bucharest, , Romania
Timisoara, , Romania
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported