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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516960-27-00

Acronym

MORF-057-201

Enrollment

Registered

2024-11-11

Start date

2022-07-22

Completion date

2025-02-19

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to severely active ulcerative colitis

Brief summary

Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score.

Detailed description

1. Frequencies and proportions for TEAEs, treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation., 2. Change from baseline to Week 12 in the Modified Mayo Clinic Score (MCS)., 3. MORF-057 concentration in plasma., 4. Plasma PK parameters.

Interventions

DRUGMORF-057 Capsule

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score.	—

Secondary

Measure	Time frame
1. Frequencies and proportions for TEAEs, treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation., 2. Change from baseline to Week 12 in the Modified Mayo Clinic Score (MCS)., 3. MORF-057 concentration in plasma., 4. Plasma PK parameters.	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026