A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC
EMERALD-1
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)
5 other identifiers
interventional
39
2 countries
17
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2022
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 23, 2022
CompletedStudy Start
First participant enrolled
April 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2023
CompletedResults Posted
Study results publicly available
November 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2025
CompletedMarch 11, 2026
February 1, 2026
1.5 years
March 10, 2022
October 18, 2024
February 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Main Cohort: Change From Baseline to Week 12 in the Robarts Histopathology Index (RHI) Score
Robarts Histopathology Index (RHI) Score: the total RHI Score ranges from 0 (no disease activity) to 33 (severe disease activity)
From baseline to 12 weeks
Secondary Outcomes (4)
Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score
From baseline to 12 weeks
Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057
12 weeks
Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057
12 weeks
Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057
12 weeks
Study Arms (1)
MORF-057
EXPERIMENTALParticipants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks.
Interventions
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Clinical Study Site
Tampa, Florida, 33609, United States
Clinical Study Site
Lafayette, Louisiana, 70503, United States
Clinical Study Site
Freehold, New Jersey, 07728, United States
Clinical Study Site
Brooklyn, New York, 11235, United States
Clinical Study Site
New York, New York, 10075, United States
Clinical Study Site
Bydgoszcz, 85-794, Poland
Clinical Study Site
Elblag, 82-300, Poland
Clinical Study Site
Katowice, 40-748, Poland
Clinical Study Site
Lodz, 90-349, Poland
Clinical Study Site
Lodz, 90-752, Poland
Clinical Study Site
Oświęcim, 32-600, Poland
Clinical Study Site
Sopot, 81-756, Poland
Clinical Study Site
Sosnowiec, 41-209, Poland
Clinical Study Site
Staszów, 28-200, Poland
Clinical Study Site
Tychy, 43-100, Poland
Clinical Study Site
Warsaw, 00-728, Poland
Clinical Study Site
Warsaw, 02-665, Poland
Related Publications (1)
Sands BE, Schreiber S, Danese S, Kierkus J, Abhyankar B, Choi MY, Soo C, Wu Y, Sun F, Lee D, Cui D, Mangada M, Singhal P, Hussain A, Rogers BN, Peyrin-Biroulet L, Feagan BG. A Phase 2 Study of MORF-057, an Oral alpha4beta7 Integrin Inhibitor in Moderately to Severely Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Feb;24(2):525-534. doi: 10.1016/j.cgh.2025.07.030. Epub 2025 Aug 6.
PMID: 40769468DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 23, 2022
Study Start
April 13, 2022
Primary Completion
October 18, 2023
Study Completion
February 19, 2025
Last Updated
March 11, 2026
Results First Posted
November 26, 2024
Record last verified: 2026-02