Clinical trial NCT05611671: A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
Official title: A Phase 2b, 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 Ulcerative Colitis (EMERALD-2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Colitis, Ulcerative
Keywords: Ulcerative Colitis (UC)
Inflammatory Bowel Disease (IBD)
a4b7
Moderate-to-severe
Integrin
EMERALD
Lead sponsor: Morphic Therapeutic, Inc
Sponsor class: INDUSTRY
First posted: 2022-11-10
Enrollment: 282
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 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).

Detailed description: This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of three active dose regimens of MORF-057 plus a placebo regimen in study participants with moderately to severely active UC. After completion of the 12-week Induction Period, participants may be switched to a different active MORF-057 regimen during the Maintenance Period. Those randomized into the placebo group in the Induction Period will be switched to receive an active MORF-057 regimen during the Maintenance Period.

Eligibility criteria: Inclusion Criteria:

* Has signs/symptoms of moderate to severe UC for at least 3 months prior to Screening
* Has evidence of UC extending at least 15 cm from the anal verge
* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Oral aminosalicylates (e.g., mesalamine, sulfasalazine, olsalazine, or balsalazide), corticosteroids, immunosuppressants (e.g., azathioprine, 6-mercaptopurine, or methotrexate), advanced therapies for UC (e.g., biologic agents, Janus kinase \[JAK\] antagonists, or sphingosine-1-phosphate \[S1P\] receptor agonists)
* Subject has no prior exposure to approved or investigational anti-integrin therapies
* Agrees to abide by the study guidelines and requirements
* Capable of giving signed informed consent

Exclusion Criteria:

* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn's disease
* 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
* Participation in any other interventional study or 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 in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS).
timeFrame: From baseline to 12 weeks
Secondary outcomes:
measure: Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS)
timeFrame: From baseline to 12 weeks
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Clinical Study Site
state: Arizona
city: Lancaster
country: United States
facility: Clinical Study Site
state: California
city: Los Angeles
country: United States
facility: Clinical Study Site
state: California
city: Kissimmee
country: United States
facility: Clinical Study Site
state: Florida
city: Witchita
country: United States
facility: Clinical Study Site
state: Kansas
city: New Brunswick
country: United States
facility: Clinical Study Site
state: New Jersey
city: New York
country: United States
facility: Clinical Study Site
state: New York
city: Mentor
country: United States
facility: Clinical Study Site
state: Ohio
city: Cedar Park
country: United States
facility: Clinical Study Site
state: Texas
city: Houston
country: United States
facility: Clinical Study Site
state: Texas
city: Blacktown
country: Australia
facility: Clinical Study Site
state: New South Wales
city: Concord
country: Australia
facility: Clinical Study Site
state: New South Wales
city: Brisbane
country: Australia
facility: Clinical Study Site
state: Queensland
city: Brisbane
country: Australia
facility: Clinical Study Site
state: Queensland
city: Parkville
country: Australia
facility: Clinical Study Site
state: Victoria
city: Murdoch
country: Australia
facility: Clinical Study Site
state: Western Australia
city: Linz
country: Austria
facility: Clinical Study Site
city: Salzburg
country: Austria
facility: Clinical Study Site
city: Vienna
country: Austria
facility: Clinical Study Site
city: Ruse
country: Bulgaria
facility: Clinical Study Site
city: Sofia
country: Bulgaria
facility: Clinical Study Site
city: Sofia
country: Bulgaria
facility: Clinical Study Site
city: Sofia
country: Bulgaria
facility: Clinical Study Site
city: Sofia
country: Bulgaria
facility: Clinical Study Site
city: Olomouc
country: Czechia
facility: Clinical Study Site
city: Prague
country: Czechia
facility: Clinical Study Site
city: Slaný
country: Czechia
facility: Clinical Study Site
city: Pärnu
country: Estonia
facility: Clinical Study Site
city: Tallinn
country: Estonia
facility: Clinical Study Site
city: Tallinn
country: Estonia
facility: Clinical Study Site
city: Tallinn
country: Estonia
facility: Clinical Study Site
city: Tartu
country: Estonia
facility: Clinical Study Site
city: Lille
country: France
facility: Clinical Study Site
city: Nice
country: France
facility: Clinical Study Site
city: Pierre-Bénite
country: France
facility: Clinical Study Site
city: Saint-Priest-en-Jarez
country: France
facility: Clinical Study Site
city: Vandœuvre-lès-Nancy
country: France
facility: Clinical Study Site
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: Tbilisi
country: Georgia
facility: Clinical Study Site
city: Heidelberg
country: Germany
facility: Clinical Study Site
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: Clinical Study Site
state: Baden-Wuerttemberg
city: Ulm
country: Germany
facility: Clinical Study Site
state: Baden-Wuerttemberg
city: Regensburg
country: Germany
facility: Clinical Study Site
state: Bavaria
city: Cologne
country: Germany
facility: Clinical Study Site
state: North Rhine-Westphalia
city: Münster
country: Germany
facility: Clinical Study Site
state: North Rhine-Westphalia
city: Leipzig
country: Germany
facility: Clinical Study Site
state: Saxony
city: Kiel
country: Germany
facility: Clinical Study Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Clinical Study Site
city: Berlin
country: Germany
facility: Clinical Study Site
city: Budapest
country: Hungary
facility: Clinical Study Site
city: Budapest
country: Hungary
facility: Clinical Study Site
city: Gyongyos
country: Hungary
facility: Clinical Study Site
city: Szekesfehervar
country: Hungary
facility: Clinical Study Site
city: Vac
country: Hungary
facility: Clinical Study Site
city: New Delhi
country: India
facility: Clinical Study Site
state: Delhi
city: Surat
country: India
facility: Clinical Study Site
state: Gujarat
city: Gurgaon
country: India
facility: Clinical Study Site
state: Haryana
city: Thiruvananthapuram
country: India
facility: Clinical Study Site
state: Kerala
city: Ludhiana
country: India
facility: Clinical Study Site
state: Punjab
city: Jaipur
country: India
facility: Clinical Study Site
state: Rajasthan
city: Jaipur
country: India
facility: Clinical Study Site
state: Rajasthan
city: Hyderabad
country: India
facility: Clinical Study Site
state: Telangana
city: Secunderabad
country: India
facility: Clinical Study Site
state: Telangana
city: Noida
country: India
facility: Clinical Study Site
state: Uttar Pradesh
city: Delhi
country: India
facility: Clinical Study Site
city: Be'er Sheva
country: Israel
facility: Clinical Study Site
city: Jerusalem
country: Israel
facility: Clinical Study Site
city: Jerusalem
country: Israel
facility: Clinical Study Site
city: Reẖovot
country: Israel
facility: Clinical Study Site
city: Florence
country: Italy
facility: Clinical Study Site
city: Milan
country: Italy
facility: Clinical Study Site
city: Milan
country: Italy
facility: Clinical Study Site
city: Milan
country: Italy
facility: Clinical Study Site
city: Padova
country: Italy
facility: Clinical Study Site
city: San Giovanni Rotondo
country: Italy
facility: Clinical Study Site
city: Turin
country: Italy
facility: Clinical Study Site
city: Busan
country: Korea, Republic of
facility: Clinical Study Site
city: Busan
country: Korea, Republic of
facility: Clinical Study Site
city: Daegu
country: Korea, Republic of
facility: Clinical Study Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Clinical Study Site
city: Seongnam-si
country: Korea, Republic of
facility: Clinical Study Site
city: Seoul
country: Korea, Republic of
facility: Clinical Study Site
city: Seoul
country: Korea, Republic of
facility: Clinical Study Site
city: Liepaja
country: Latvia
facility: Clinical Study Site
city: Riga
country: Latvia
facility: Clinical Study Site
city: Riga
country: Latvia
facility: Clinical Study Site
city: Panevezys
country: Lithuania
facility: Clinical Study Site
city: Vilnius
country: Lithuania
facility: Clinical Study Site
city: Bydgoszcz
country: Poland
facility: Clinical Study Site
city: Elbląg
country: Poland
facility: Clinical Study Site
city: Kraków
country: Poland
facility: Clinical Study Site
city: Lublin
country: Poland
facility: Clinical Study Site
city: Lublin
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: Sopot
country: Poland
facility: Clinical Study Site
city: Staszów
country: Poland
facility: Clinical Study Site
city: Szczecin
country: Poland
facility: Clinical Study Site
city: Tychy
country: Poland
facility: Clinical Study Site
city: Wadowice
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: Zamość
country: Poland
facility: Clinical Study Site
city: Łódź
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: Belgrade
country: Serbia
facility: Clinical Study Site
city: Belgrade
country: Serbia
facility: Clinical Study Site
city: Pančevo
country: Serbia
facility: Clinical Study Site
city: Zrenjanin
country: Serbia
facility: Clinical Study Site
city: Bratislava
country: Slovakia
facility: Clinical Study Site
city: Košice
country: Slovakia
facility: Clinical Study Site
city: Prešov
country: Slovakia
facility: Clinical Study Site
city: Changhua City
country: Taiwan
facility: Clinical Study Site
city: Chiayi City
country: Taiwan
facility: Clinical Study Site
city: New Taipei City
country: Taiwan
facility: Clinical Study Site
city: Taichung
country: Taiwan
facility: Clinical Study Site
city: Taipei
country: Taiwan
facility: Clinical Study Site
city: Taipei
country: Taiwan
facility: Clinical Study Site
city: Taipei
country: Taiwan
facility: Clinical Study Site
Study officials:
References: