Clinical trial NCT06226883: A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Crohn's Disease
Keywords: Crohn's disease (CD)
Inflammatory bowel disease (IBD)
a4b7
Moderate-to-severe
Integrin
GARNET
Lead sponsor: Morphic Therapeutic, Inc
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 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 2 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 Maintenance Extension.

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

Primary outcomes:
measure: Proportion of participants with endoscopic response at Week 14 determined using the Simple Endoscopic Score-CD (SES-CD)
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: Proportion of participants with clinical response at Week 14 determined using the Crohn's Disease Activity Index (CDAI)
timeFrame: Baseline to Week 14
measure: Proportion of participants with clinical remission at Week 14 determined using the CDAI.
timeFrame: Baseline to Week 14
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Clinical Study Site
state: California
city: Shreveport
country: United States
facility: Clinical Study Site
state: Louisiana
city: Raleigh
country: United States
facility: Clinical Study Site
state: North Carolina
city: Summerville
country: United States
facility: Clinical Study Site
state: South Carolina
city: Johnson City
country: United States
facility: Clinical Study Site
state: Tennessee
city: Cedar Park
country: United States
facility: Clinical Study Site
state: Texas
city: Houston
country: United States
facility: Clinical Study Site
state: Texas
city: Southlake
country: United States
facility: Clinical Study Site
state: Texas
city: Tyler
country: United States
facility: Clinical Study Site
state: Texas
city: Ogden
country: United States
facility: Clinical Study Site
state: Utah
city: Lynchburg
country: United States
facility: Clinical Study Site
state: Virginia
city: Innsbruck
country: Austria
facility: Clinical Study Site
city: Salzburg
country: Austria
facility: Clinical Study Site
city: St. Poelten
country: Austria
facility: Clinical Study Site
city: Vienna
country: Austria
facility: Clinical Study Site
city: Brasilia
country: Brazil
facility: Clinical Study Site
city: Santo Andre
country: Brazil
facility: Clinical Study Site
city: Sao Paulo
country: Brazil
facility: Clinical Study Site
city: Toronto
country: Canada
facility: Clinical Study Site
state: Ontario
city: Woodbridge
country: Canada
facility: Clinical Study Site
state: Ontario
city: Calgary
country: Canada
facility: Clinical Study Site
city: Halifax
country: Canada
facility: Clinical Study Site
city: London
country: Canada
facility: Clinical Study Site
city: Montreal
country: Canada
facility: Clinical Study Site
city: Toronto
country: Canada
facility: Clinical Study Site
city: Armenia
country: Colombia
facility: Clinical Study Site
city: Cali
country: Colombia
facility: Clinical Study Site
city: Floridablanca
country: Colombia
facility: Clinical Study Site
city: Medellin
country: Colombia
facility: Clinical Study Site
city: Medellin
country: Colombia
facility: Clinical Study Site
city: Soledad
country: Colombia
facility: Clinical Study Site
city: Osijek
country: Croatia
facility: Clinical Study Site
city: Rijeka
country: Croatia
facility: Clinical Study Site
city: Virovitica
country: Croatia
facility: Clinical Study Site
city: Zadar
country: Croatia
facility: Clinical Study Site
city: Zagreb
country: Croatia
facility: Clinical Study Site
city: Brno
country: Czechia
facility: Clinical Study Site
city: Brno
country: Czechia
facility: Clinical Study Site
city: Prague
country: Czechia
facility: Clinical Study Site
city: Pierre-Benite
country: France
facility: Clinical Study Site
city: Saint-Priest-en-Jarez
country: France
facility: Clinical Study Site
city: Vandoeuvre-les-Nancy
country: France
facility: Clinical Study Site
city: Batumi
country: Georgia
facility: Clinical Study Site
city: Tbilisi
country: Georgia
facility: Clinical Study Site
city: Tbilisi
country: Georgia
facility: Clinical Study Site 2
city: Tbilisi
country: Georgia
facility: Clinical Study Site
city: Tbilisi
country: Georgia
facility: Clinical Study Site
city: Tbilisi
country: Georgia
facility: Clinical Study Site
city: Heidelberg
country: Germany
facility: Clinical Study Site
state: Baden-Wuerttemberg
city: Halle
country: Germany
facility: Clinical Study Site
state: Saxony-Anhalt
city: Berlin
country: Germany
facility: Clinical Study Site
city: Berlin
country: Germany
facility: Clinical Study Site
city: Berlin
country: Germany
facility: Clinical Study Site
city: Dachau
country: Germany
facility: Clinical Study Site
city: Duisburg
country: Germany
facility: Clinical Study Site
city: Kiel
country: Germany
facility: Clinical Study Site
city: Ulm
country: Germany
facility: Clinical Study Site
city: Wipperfurth
country: Germany
facility: Clinical Study Site
city: Bekescsaba
country: Hungary
facility: Clinical Study Site
city: Budapest
country: Hungary
facility: Clinical Study Site
city: Eger
country: Hungary
facility: Clinical Study Site
city: Gyongyos
country: Hungary
facility: Clinical Study Site
city: Szekesfehervar
country: Hungary
facility: Clinical Study Site
city: Szekszárd
country: Hungary
facility: Clinical Study Site
city: Kochi
country: India
facility: Clinical Study Site
state: Kerala
city: Pune
country: India
facility: Clinical Study Site
state: Maharashtra
city: Jaipur
country: India
facility: Clinical Study Site
state: Rajasthan
city: Chennai
country: India
facility: Clinical Study Site
state: Tamil Nadu
city: Varanasi
country: India
facility: Clinical Study Site
state: Uttar Pradesh
city: Ahmedabad
country: India
facility: Clinical Study Site
city: Jaipur
country: India
facility: Clinical Study Site
city: Rajkot
country: India
facility: Clinical Study Site
city: Rājkot
country: India
facility: Clinical Study Site
city: Secunderabad
country: India
facility: Clinical Study Site
city: Bologna
country: Italy
facility: Clinical Study Site
city: Milan
country: Italy
facility: Clinical Study Site
city: Milan
country: Italy
facility: Clinical Study Site
city: Negrar
country: Italy
facility: Clinical Study Site
city: Rome
country: Italy
facility: Clinical Study Site
city: Rozzano
country: Italy
facility: Clinical Study Site
city: San Donato Milanese
country: Italy
facility: Clinical Study Site
city: San Giovanni Rotondo
country: Italy
facility: Clinical Study Site
city: Udine
country: Italy
facility: Clinical Study Site
city: Almaty
country: Kazakhstan
facility: Clinical Study Site
city: Astana
country: Kazakhstan
facility: Clinical Study Site
city: Astana
country: Kazakhstan
facility: Clinical Study Site
city: Karaganda
country: Kazakhstan
facility: Clinical Study Site
city: Semey
country: Kazakhstan
facility: Clinical Study Site
city: Shymkent
country: Kazakhstan
facility: Clinical Study Site
city: Shymkent
country: Kazakhstan
facility: Clinical Study Site
city: Riga
country: Latvia
facility: Clinical Study Site
city: Durango
country: Mexico
facility: Clinical Study Site
city: Oaxaca
country: Mexico
facility: Clinical Study Site
city: Queretaro
country: Mexico
facility: Clinical Study Site
city: Bydgoszcz
country: Poland
facility: Clinical Study Site
city: Bydgoszcz
country: Poland
facility: Clinical Study Site
city: Bydgoszcz
country: Poland
facility: Clinical Study Site
city: Czestochowa
country: Poland
facility: Clinical Study Site
city: Elblag
country: Poland
facility: Clinical Study Site
city: Elbląg
country: Poland
facility: Clinical Study Site
city: Gdansk
country: Poland
facility: Clinical Study Site
city: Katowice
country: Poland
facility: Clinical Study Site
city: Katowice
country: Poland
facility: Clinical Study Site
city: Kraków
country: Poland
facility: Clinical Study Site
city: Opole
country: Poland
facility: Clinical Study Site
city: Poznan
country: Poland
facility: Clinical Study Site
city: Poznan
country: Poland
facility: Clinical Study Site
city: Poznan
country: Poland
facility: Clinical Study Site
city: Sopot
country: Poland
facility: Clinical Study Site
city: Szczecin
country: Poland
facility: Clinical Study Site
city: Tychy
country: Poland
facility: Clinical Study Site
city: Warsaw
country: Poland
facility: Clinical Study Site
city: Warsaw
country: Poland
facility: Clinical Study Site
city: Warsaw
country: Poland
facility: Clinical Study Site
city: Warsaw
country: Poland
facility: Clinical Study Site
city: Wroclaw
country: Poland
facility: Clinical Study Site
city: Wroclaw
country: Poland
facility: Clinical Study Site
city: Bucharest
country: Romania
facility: Clinical Study Site
city: Bucharest
country: Romania
facility: Clinical Study Site
city: Bucharest
country: Romania
facility: Clinical Study Site
city: Constanta
country: Romania
facility: Clinical Study Site
city: Timişoara
country: Romania
facility: Clinical Study Site
city: Belgrade
country: Serbia
facility: Clinical Study Site
city: Belgrade
country: Serbia
facility: Clinical Study Site
city: Kragujevac
country: Serbia
facility: Clinical Study Site
city: Leskovac
country: Serbia
facility: Clinical Study Site
city: Novi Sad
country: Serbia
facility: Clinical Study Site
city: Uzice
country: Serbia
facility: Clinical Study Site
city: Zrenjanin
country: Serbia
facility: Clinical Study Site
city: Bratislava
country: Slovakia
facility: Clinical Study Site
city: Kosice
country: Slovakia
facility: Clinical Study Site
city: Presov
country: Slovakia
facility: Clinical Study Site
city: A Coruna
country: Spain
facility: Clinical Study Site
city: Leon
country: Spain
facility: Clinical Study Site
city: Lleida
country: Spain
facility: Clinical Study Site
city: Madrid
country: Spain
facility: Clinical Study Site
city: Madrid
country: Spain
facility: Clinical Study Site
city: Seville
country: Spain
facility: Clinical Study Site
city: Valencia
country: Spain
facility: Clinical Study Site
Study officials:
References: