Clinical trial NCT05291689: A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
Official title: A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Colitis, Ulcerative
Keywords: Ulcerative Colitis (UC)
Inflammatory Bowel Disease (IBD)
a4b7
Moderately to severely active ulcerative colitis
Integrin
Lead sponsor: Morphic Therapeutic, Inc
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)

Detailed description: The main part of this Phase 2a study will consist of 3 study periods: a Screening Period, a Treatment Period and a Safety Follow-up Period. All participants who complete the open-label Treatment Period will have the opportunity to continue their treatment in an optional 26-week Long-term Extension study after completing the Week 52 assessments.

Eligibility criteria: Inclusion Criteria:

* Has signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening
* Has evidence of UC extending at least 15 cm from the anal verge
* Is bio-naïve or had an inadequate response, loss of response, or intolerance to other UC drugs
* 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
* Primary non-responder to vedolizumab or other 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: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
timeFrame: From baseline to 12 weeks
Secondary outcomes:
measure: Change From Baseline to Week 12 in the Modified Mayo Clinic Score
timeFrame: From baseline to 12 weeks
measure: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057
timeFrame: 12 weeks
measure: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057
timeFrame: 12 weeks
measure: Area Under the Curve (AUC) Following Multiple Doses of MORF-057
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Clinical Study Site
state: Florida
city: Lafayette
country: United States
facility: Clinical Study Site
state: Louisiana
city: Freehold
country: United States
facility: Clinical Study Site
state: New Jersey
city: Brooklyn
country: United States
facility: Clinical Study Site
state: New York
city: New York
country: United States
facility: Clinical Study Site
state: New York
city: Bydgoszcz
country: Poland
facility: Clinical Study Site
city: Elblag
country: Poland
facility: Clinical Study Site
city: Katowice
country: Poland
facility: Clinical Study Site
city: Lodz
country: Poland
facility: Clinical Study Site
city: Oswiecim
country: Poland
facility: Clinical Study Site
city: Sopot
country: Poland
facility: Clinical Study Site
city: Sosnowiec
country: Poland
facility: Clinical Study Site
city: Staszów
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: Łódź
country: Poland
facility: Clinical Study Site
Study officials:
References: