Inflammatory Bowel DiseasesPhase 2EMERALD-2NCT05611671
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
A Phase 2 study testing MORF-057 in people with Inflammatory Bowel Diseases and Colitis, Ulcerative, run by Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company) at 102 sites in 21 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Colitis, Ulcerative
- What is being tested?
- MORF-057
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 102 sitesin 21 countries
- Study dates
- 21 Nov 2022to 21 Sep 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
102 sites in 21 countries.
102 sites in 21 countries
Poland18 sites
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794
St. John Paul 2nd Municipal Hospital in Elblag
Elblag, 82-300
"Vita Longa" Non-Public Healthcare Facility, Limited Liability Company
Katowice, 40-748
Krakow Medical Center
Krakow, 31-501
IP Clinic
Lodz, 90-752
University Teaching Hospital No. 4 in Lublin
Lublin, 20-090
ETG Lublin
Lublin, 20-412
Twoja Przychodnia Opolskie Centrum Medyczne
Opole, 45 819
EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
Poznan, 60-309
Twoja Przychodnia Pcm
Poznan, 60-324
Endoscopy Limited Liability Company
Sopot, 81-756
New health-CK, Kieltucki and partners g.p.
Staszów, 28-200
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434
H-T. Medical Center
Tychy, 43-100
Centrum Medyczne Reuma Park
Warsaw, 02-665
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
EMC Medical Institute Joint Stock Company, EuroMediCare Specialist Outpatient Clinics in Wroclaw
Wroclaw, 54-144
ETG Zamość
Zamość, 22-400
India10 sites
Fortis Memorial Research Institute(FMRI)
Gūrgaon, 122002
Gleneagles Hospital
Hyderabad, 500004
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur, 302004
S R Kalla Memorial Gastro and General Hospital
Jaipur, 302006
Dayanand Medical College and Hospital
Ludhiana, 141001
All India Institute of Medical Sciences
New Delhi, 110029
Fortis Hospital
Noida, 201301
Yashoda Hospital
Secunderabad, 500003
SIDS Hospital and Research Centre
Surat, 395002
Government Medical College
Thiruvananthapuram, 695011
United States8 sites
Innova Clinical Trials
Coral Gables, Florida, 33145
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Gastro Care Institute
Lancaster, California, 93534
TLC Clinical Research Inc.
Los Angeles, California, 90048
Great Lakes Gastroenterology
Mentor, Ohio, 44060
Eminat, LLC - Miramar
Miramar, Florida, 33027
Robert Wood Johnson University Medical School
New Brunswick, New Jersey, 08901
Arizona Digestive Health - Sun City
Sun City, Arizona, 85351
Taiwan7 sites
Changhua Christian Hospital
Changhua, 50006
Chia-Yi Christian Hospital
Chiayi City, 600
Tri-Service General Hospital
Neihu Taipei, 11490
China Medical University Hospital
Taichung, 404
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 112201
Far Eastern Memorial Hospital
Taipei, 220
Georgia6 sites
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi, 0101
Curatio, Jsc
Tbilisi, 0114
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0159
LTD Aversi Clinic
Tbilisi, 0160
Medical Center "CITO" Ltd.
Tbilisi, 0179
LTD The First Medical Center
Tbilisi, 0180
Hungary6 sites
Semmelweis Medical University
Budapest, 1083
Semmelweis University, Department of Internal Medicine and Haematology, Division of Internal Medicine and Gastroenterology
Budapest, H-1088
Bugat Pal Korhaz
Gyöngyös, 3200
Fejér Megyei Szent György Egyetemi Oktató Kórház
Székesfehérvár, 8000
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár, H-8000
Javorszky Odon Korhaz
Vác, 2600
Australia5 sites
Blacktown Hospital
Blacktown, 2148
Concord Repatriation General Hospital
Concord, 2139
Royal Brisbane and Women's Hospital
Herston, QLD 4029
Fiona Stanley Hospital
Murdoch, 6150
Mater Adult Hospital Brisbane
South Brisbane, 4101
Estonia5 sites
LV Venter OU
Pärnu, 80010
OU Innomedica
Tallinn, 10117
East Tallinn Central Hospital
Tallinn, 10138
West Tallinn Central Hospital
Tallinn, 10617
University of Tartu
Tartu, 51014
Italy5 sites
Ospedale Luigi Sacco
Milan, 20157
Hospital of Padova
Padova, 35128
IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali
Rozzano, 20089
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
IRCCS Ospedale San Raffaele
Segrate, 20132
Bulgaria4 sites
Medical Center "Rusemed" EOOD
Rousse, 7005
University Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic"
Sofia, 1202
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda
Sofia, 1407
Second Multiprofile Hospital for Active Treatment - Sofia
Sofia, 2700
Germany4 sites
Charite - University Hospital Berlin
Berlin, 10117
Krankenhaus Waldfriede
Berlin, 14163
University Hospital Schleswig-Holstein
Kiel, 24105
University Hospital Ulm
Ulm, 89081
Austria3 sites
Order Hospital Linz Ltd. - Hospital of Sisters of Mercy
Linz, 4010
Salzburg Regional Hospital
Salzburg, 5020
Medical University of Vienna
Vienna, 1090
Latvia3 sites
Liepaja Regional Hospital
Liepāja, LV-3414
Digestive Diseases Center "Gastro"
Riga, 1079
Pauls Stradins Clinical Univeristy Hospital
Riga, LV-1002
Serbia3 sites
Zvezdara University Medical Center
Belgrade, 11 000
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11000
General Hospital "Djordje Joanovic"
Zrenjanin, 23000
Slovakia3 sites
Cliniq s.r.o.
Bratislava, 811 09
ENDOMED s.r.o.
Košice, 04013
Gastro LM s.r.o.
Prešov, 08001
South Korea3 sites
Dong-A University Hospital
Busan, 49201
Yeungnam Univeristy Medical Center
Daegu, 42415
Kyung Hee University Hospital
Seoul, 02447
Czechia2 sites
PreventaMed, s.r.o.
Olomouc, 77900
Clinoxus s.r.o., Outpatient Clinic Budejovicka
Prague, 140 00
Israel2 sites
Shaare Zedek Medical Center, Digestive Diseases Institute
Jerusalem, 91004
Kaplan Medical Center, Institute of Gastroenterology and Liver Diseases
Rehovot, 7661041
Lithuania2 sites
Republican Panevezys Hospital
Panevezys, 35144
Vilnius University Hospital Santaros Klinikos
Vilnius, LT-08406
Romania2 sites
Colentina Clinical Hospital
Bucharest, 020125
Center of Diagnosis and Treatment Provita
Bucharest, 21494
France1 site
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, 06202
About this study
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)
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).
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative
- Being tested
- MORF-057, Placebo
- Keywords
- Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD), a4b7, Moderate-to-severe, Integrin, EMERALD
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORF-057Drug
Also called LY4268989
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
PlaceboDrug
Matching placebo (identical appearance to MORF-057) administered orally.
| Study group | Role | What they receive |
|---|---|---|
| MORF-057 200 mg BID | Experimental | Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks. Receives: Drug: MORF-057 |
| MORF-057 100 mg BID | Experimental | Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks. Receives: Drug: MORF-057 |
| MORF-057 100 mg QD-M | Experimental | Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks. Receives: Drug: MORF-057 |
| Placebo | Placebo comparator | Participants received an oral dose of matching placebo for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS)
- The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease.
- Clinical remission per mMCS is defined as rectal bleeding subscore of 0; a stool frequency subscore of < or =1; and an endoscopy subscore of < or =1 without friability.
Measured: Week 12
Secondary outcomes (1)
Percentage of Participants in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS)
- The mMCS is a scoring system for assessment of ulcerative colitis activity and is a composite of Endoscopic subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration)), Stool Frequency subscore (range: 0=Normal number of stools to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The mMCS total score ranges from 0 to 9, with higher scores indicating more severe disease.
- Clinical response per mMCS is defined as decrease from baseline in the mMCS score > or =2 points and > or =30% from baseline, plus a decrease in rectal bleeding subscore > or =1 or an absolute rectal bleeding subscore < or =1.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start21 Nov 2022
- Primary completion28 Nov 2024
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611671
- Sponsor's protocol ID
- 27398
- Other IDs
- J6E-MC-KWAD, MORF-057-202, 2022-500953-17-00
- Acronym
- EMERALD-2
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2022
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No