A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, MORF-057.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Diseases, Crohn's Disease. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Austria, Bosnia and Herzegovina, Brazil +23
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Drug Placebo
Matching placebo (identical appearance to MORF-057) administered orally. - Drug MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Primary outcome measures
- Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD) [Time frame: Baseline to Week 14]
Secondary outcome measures (2)
- Proportion of participants with clinical response at Week 14 as determined using the Crohn's Disease Activity Index (CDAI) [Time frame: Baseline to Week 14]
- Proportion of participants with clinical remission at Week 14 as determined using the CDAI. [Time frame: Baseline to Week 14]
Eligibility criteria
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)
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Poland · 26 centers
Center list to be confirmed — check the primary protocol.
United States · 25 centers
- Gastro Care Institute — Lancaster
- Infinity Clinical Research — San Diego
- Peak Gastroenterology Associates - Colorado Springs — Colorado Springs
- Clinical Research of Osceola — Kissimmee
- Bioresearch Partner-Kendale Lakes — Miami
- Endoscopic Research Inc — Orlando
- Tropical Clinical Trials — Palmetto Bay
- Atlanta Gastroenterology Specialists, PC — Atlanta
- … and 17 more centers
India · 16 centers
Center list to be confirmed — check the primary protocol.
Japan · 15 centers
Center list to be confirmed — check the primary protocol.
Germany · 13 centers
Center list to be confirmed — check the primary protocol.
Canada · 12 centers
- CaRe Clinic — Alberta
- Integrated University Health and Social Services Center of Saguenay-Lac-Saint-Jean — Chicoutimi
- Nova Scotia Health Authority — Halifax
- Prairie Institute of Liver and Luminal Advanced Research — Lethbridge
- London Health Sciences Centre — London
- London Digestive Disease Institute — London
- Clinique IMD — Montreal
- Diex Recherche Quebec Inc. — Québec
- … and 4 more centers
Italy · 12 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 12 centers
Center list to be confirmed — check the primary protocol.
Australia · 8 centers
- Southern Adelaide Local Health Network — Bedford Park
- Royal Brisbane and Women's Hospital — Herston
- IBD SA SA Group of Specialists — Kurralta Park
- The Alfred Hospital — Melbourne
- St. Vincent's Hospital — Melbourne
- Royal Perth Hospital — Perth
- Sir Charles Gairdner Hospital — Perth
- Princess Alexandra Hospital, Metro South Health — Woolloongabba, QLD
Mexico · 8 centers
Center list to be confirmed — check the primary protocol.
Kazakhstan · 7 centers
Center list to be confirmed — check the primary protocol.
Brazil · 6 centers
- NewData FBHC, NewData Clinical Research — Aracaju
- Faculdade de Medicina da UNESP — Botucatu
- Chronos Pesquisa Clínica — Brasília
- Loema Clinical Research Institute and Consultants SS Ltda- i9 Clinical Research — Campinas
- Pesquisare — Santo André
- Clínica Hepatogastro JK — São Paulo
Colombia · 6 centers
- Cardiomet Cequin S.A.S., Research Unit — Armenia
- Fundación Valle del Lili — Cali
- Cardiovascular Foundation of Colombia — Floridablanca
- Corporation for Health Studies "CES" — Medellín
- Hospital Pablo Tobon Uribe — Medellín
- Northern University Foundation Hospital — Soledad
Georgia · 6 centers
- High Technology Hospital Medcenter LLC — Batumi
- Emergency Cardiology Center by Academician G. Chapidze LLC — Tbilisi
- … and 4 more centers
Hungary · 6 centers
Center list to be confirmed — check the primary protocol.
Serbia · 6 centers
Center list to be confirmed — check the primary protocol.
Spain · 6 centers
Center list to be confirmed — check the primary protocol.
Austria · 4 centers
- Medical University Hematology — Innsbruck
- Salzburg Regional Hospital — Salzburg
- University Hospital St. Poelten — Sankt Pölten
- Medical University of Vienna — Vienna
Czechia · 4 centers
- SurGal Clinic s.r.o. — Brno
- Military Hospital Brno, — Brno
- Clinoxus s.r.o., Outpatient Clinic Budejovicka — Prague
- Axon Clinical, s.r.o. — Prague
Moldova · 4 centers
Center list to be confirmed — check the primary protocol.
Romania · 4 centers
Center list to be confirmed — check the primary protocol.
Slovakia · 4 centers
Center list to be confirmed — check the primary protocol.
Bosnia and Herzegovina · 3 centers
- University Clinical Centre of the Republic of Srpska — Banja Luka
- Hospital Plava Medical Group — Tuzla
- Cantonal Hospital Zenica, Department of Internal Medicine — Zenica
Croatia · 3 centers
- Poliklinika Borzan — Osijek
- Specialty hospital Medico Rijeka — Rijeka
- Poliklinika Solmed — Zagreb
Estonia · 3 centers
- East Tallinn Central Hospital — Tallinn
- West Tallinn Central Hospital — Tallinn
- Tartu University Hospital, Department of Gastroenterology — Tartu
Bulgaria · 2 centers
- "Medical Center Kanev" EOOD — Rousse
- Diagnostic Consultative Center XX - Sofia — Sofia
France · 2 centers
- Hospices Civils de Lyon - Lyon Sud — Pierre-Bénite
- CHRU Nancy Brabois - Hôpital d'Enfants — Vandœuvre-lès-Nancy
Latvia · 2 centers
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06226883 · 27383 · J6E-MC-KWAB · MORF-057-203 · U1111-1297-7265 · 2023-508158-24