A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

Inflammatory Bowel Diseases Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05291689
• Other study ID #: MORF-057-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 24, 2022
• Est. completion date: February 2025

Study information

• Verified date: December 2023
• Source: Morphic Therapeutic, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer

Intervention

Drug:
• MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin a4ß7 and is administered orally.

Locations

Country	Name	City	State
Poland	Clinical Study Site	Bydgoszcz
Poland	Clinical Study Site	Elblag
Poland	Clinical Study Site	Katowice
Poland	Clinical Study Site	Lodz
Poland	Clinical Study Site	Lódz
Poland	Clinical Study Site	Oswiecim
Poland	Clinical Study Site	Sopot
Poland	Clinical Study Site	Sosnowiec
Poland	Clinical Study Site	Staszów
Poland	Clinical Study Site	Tychy
Poland	Clinical Study Site	Warsaw
Poland	Clinical Study Site	Warsaw
United States	Clinical Study Site	Brooklyn	New York
United States	Clinical Study Site	Freehold	New Jersey
United States	Clinical Study Site	Lafayette	Louisiana
United States	Clinical Study Site	New York	New York
United States	Clinical Study Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Morphic Therapeutic, Inc

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score		From baseline to 12 weeks
Secondary	Frequencies and proportions for treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation overtime		12 weeks
Secondary	Change from baseline to Week 12 in the Modified Mayo Clinic Score		From baseline to 12 weeks
Secondary	Maximum Plasma Concentration (Cmax) during single and multiple doses of MORF-057		12 weeks
Secondary	Time to reach Cmax (Tmax) during single and multiple doses of MORF-057		12 weeks
Secondary	Area under the curve (AUC) following single and multiple doses of MORF-057		12 weeks