A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Recruiting · NCT06226883 · Interventional (participants receive a specific treatment) · Lead sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
View the official record on ClinicalTrials.gov →Interventions studied
MORF-057Placebo
What this trial is about
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).
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 13 US states.
- 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
- 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
- Navneet Memorial Hospital SUSHRUSHA - Ahmedabad, India
- CaRe Clinic - Alberta, Canada
- Scientific Research Institute of Cardiology and Internal Disease of the Ministry of Health of the Republic of Kazakhstan - Almaty, Kazakhstan
- NewData FBHC, NewData Clinical Research - Aracaju, Brazil
- Cardiomet Cequin S.A.S., Research Unit - Armenia, Colombia
- Asahikawa Medical College Hospital - Asahikawa, Japan
- National Research Medical Center - Astana, Kazakhstan
- Sana Clinic - Astana, Kazakhstan
- University Clinical Centre of the Republic of Srpska - Banja Luka, Bosnia and Herzegovina
- High Technology Hospital Medcenter LLC - Batumi, Georgia
- Southern Adelaide Local Health Network - Bedford Park, Australia
- Zvezdara University Medical Center - Belgrade, Serbia
- Clinical Center " Dr Dragisa Misovic Dedinje" - Belgrade, Serbia
- Clinical Hospital Center Bezanijska Kosa - Belgrade, Serbia
- Charite - University Hospital Berlin - Berlin, Germany
- DRK Clinic Berlin-Koepenick - Berlin, Germany
- Institute of Medical Sciences & SUM Hospital, Siksha 'O' Anusandhan, Department of Gastroenterology & Hepatology - Bhubaneswar, India
- Policlinico S. Orsola-Malpighi - Bologna, Italy
- Faculdade de Medicina da UNESP - Botucatu, Brazil
- Chronos Pesquisa Clínica - Brasília, Brazil
- Cliniq s.r.o. - Bratislava, Slovakia
- Poliambulanza Hospital - Brescia, Italy
- SurGal Clinic s.r.o. - Brno, Czechia
- Military Hospital Brno, - Brno, Czechia
- "Sfanta Vineri" Medical Center - Bucharest, Romania
- Monza Oncology Hospital SRL - Bucharest, Romania
- Colentina Clinical Hospital - Bucharest, Romania
- Semmelweis Medical University - Budapest, Hungary
- Institute of Science Tokyo Hospital - Bunkyō, Japan
- "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
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz IV. Belgyogyaszat - Békéscsaba, Hungary
- Fundación Valle del Lili - Cali, Colombia
- Loema Clinical Research Institute and Consultants SS Ltda- i9 Clinical Research - Campinas, Brazil
Showing 60 of 225 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →