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| ID | Type | Description | Link |
|---|---|---|---|
| J6E-MC-KWAD | Other Identifier | Eli Lilly and Company | |
| MORF-057-202 | Other Identifier | Morphic Therapeutic, Inc | |
| 2022-500953-17-00 | EU Trial (CTIS) Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORF-057 200 mg BID | Experimental | Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks. |
|
| MORF-057 100 mg BID | Experimental | Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks. |
|
| 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. |
|
| Placebo | Placebo Comparator | Participants received an oral dose of matching placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORF-057 | Drug | MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS) |
| Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS) |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Digestive Health - Sun City | Sun City | Arizona | 85351 | United States | ||
| Gastro Care Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | MORF-057 200 mg BID | Participants received a 200 milligram (mg) oral dose of MORF-057 twice daily (BID) for 12 weeks. |
| FG001 | MORF-057 100 mg BID | Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2025 | Sep 18, 2025 |
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|
| Placebo | Drug | Matching placebo (identical appearance to MORF-057) administered orally. |
|
| Week 12 |
| Lancaster |
| California |
| 93534 |
| United States |
| TLC Clinical Research Inc. | Los Angeles | California | 90048 | United States |
| Innova Clinical Trials | Coral Gables | Florida | 33145 | United States |
| Eminat, LLC - Miramar | Miramar | Florida | 33027 | United States |
| Robert Wood Johnson University Medical School | New Brunswick | New Jersey | 08901 | United States |
| Great Lakes Gastroenterology | Mentor | Ohio | 44060 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Blacktown Hospital | Blacktown | 2148 | Australia |
| Concord Repatriation General Hospital | Concord | 2139 | Australia |
| Royal Brisbane and Women's Hospital | Herston | QLD 4029 | Australia |
| Fiona Stanley Hospital | Murdoch | 6150 | Australia |
| Mater Adult Hospital Brisbane | South Brisbane | 4101 | Australia |
| Order Hospital Linz Ltd. - Hospital of Sisters of Mercy | Linz | 4010 | Austria |
| Salzburg Regional Hospital | Salzburg | 5020 | Austria |
| Medical University of Vienna | Vienna | 1090 | Austria |
| Medical Center "Rusemed" EOOD | Rousse | 7005 | Bulgaria |
| University Multiprofile Hospital for Active Treatment "ACIBADEM City Clinic" | Sofia | 1202 | Bulgaria |
| Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda | Sofia | 1407 | Bulgaria |
| Second Multiprofile Hospital for Active Treatment - Sofia | Sofia | 2700 | Bulgaria |
| PreventaMed, s.r.o. | Olomouc | 77900 | Czechia |
| Clinoxus s.r.o., Outpatient Clinic Budejovicka | Prague | 140 00 | Czechia |
| LV Venter OU | Pärnu | 80010 | Estonia |
| OU Innomedica | Tallinn | 10117 | Estonia |
| East Tallinn Central Hospital | Tallinn | 10138 | Estonia |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| University of Tartu | Tartu | 51014 | Estonia |
| Centre Hospitalier Universitaire de Nice - Hôpital l'Archet | Nice | 06202 | France |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC | Tbilisi | 0101 | Georgia |
| Curatio, Jsc | Tbilisi | 0114 | Georgia |
| JSC Infectious Diseases, AIDS and Clinical Immunology Research Center | Tbilisi | 0159 | Georgia |
| LTD Aversi Clinic | Tbilisi | 0160 | Georgia |
| Medical Center "CITO" Ltd. | Tbilisi | 0179 | Georgia |
| LTD The First Medical Center | Tbilisi | 0180 | Georgia |
| Charite - University Hospital Berlin | Berlin | 10117 | Germany |
| Krankenhaus Waldfriede | Berlin | 14163 | Germany |
| University Hospital Schleswig-Holstein | Kiel | 24105 | Germany |
| University Hospital Ulm | Ulm | 89081 | Germany |
| Semmelweis Medical University | Budapest | 1083 | Hungary |
| Semmelweis University, Department of Internal Medicine and Haematology, Division of Internal Medicine and Gastroenterology | Budapest | H-1088 | Hungary |
| Bugat Pal Korhaz | Gyöngyös | 3200 | Hungary |
| Fejér Megyei Szent György Egyetemi Oktató Kórház | Székesfehérvár | 8000 | Hungary |
| Fejer County St. Gyorgy University Teaching Hospital | Székesfehérvár | H-8000 | Hungary |
| Javorszky Odon Korhaz | Vác | 2600 | Hungary |
| Fortis Memorial Research Institute(FMRI) | Gurgaon | 122002 | India |
| Gleneagles Hospital | Hyderabad | 500004 | India |
| Sawai Man Singh Medical College Hospital (SMS Hospital) | Jaipur | 302004 | India |
| S R Kalla Memorial Gastro and General Hospital | Jaipur | 302006 | India |
| Dayanand Medical College and Hospital | Ludhiana | 141001 | India |
| All India Institute of Medical Sciences | New Delhi | 110029 | India |
| Fortis Hospital | Noida | 201301 | India |
| Yashoda Hospital | Secunderabad | 500003 | India |
| SIDS Hospital and Research Centre | Surat | 395002 | India |
| Government Medical College | Thiruvananthapuram | 695011 | India |
| Shaare Zedek Medical Center, Digestive Diseases Institute | Jerusalem | 91004 | Israel |
| Kaplan Medical Center, Institute of Gastroenterology and Liver Diseases | Rehovot | 7661041 | Israel |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Hospital of Padova | Padova | 35128 | Italy |
| IRCCS Istituto Clinico Humanitas- Centro Malattie Infiammatorie Intestinali | Rozzano | 20089 | Italy |
| IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | 71013 | Italy |
| IRCCS Ospedale San Raffaele | Segrate | 20132 | Italy |
| Liepaja Regional Hospital | Liepāja | LV-3414 | Latvia |
| Digestive Diseases Center "Gastro" | Riga | 1079 | Latvia |
| Pauls Stradins Clinical Univeristy Hospital | Riga | LV-1002 | Latvia |
| Republican Panevezys Hospital | Panevezys | 35144 | Lithuania |
| Vilnius University Hospital Santaros Klinikos | Vilnius | LT-08406 | Lithuania |
| CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska | Bydgoszcz | 85-794 | Poland |
| St. John Paul 2nd Municipal Hospital in Elblag | Elblag | 82-300 | Poland |
| "Vita Longa" Non-Public Healthcare Facility, Limited Liability Company | Katowice | 40-748 | Poland |
| Krakow Medical Center | Krakow | 31-501 | Poland |
| IP Clinic | Lodz | 90-752 | Poland |
| University Teaching Hospital No. 4 in Lublin | Lublin | 20-090 | Poland |
| ETG Lublin | Lublin | 20-412 | Poland |
| Twoja Przychodnia Opolskie Centrum Medyczne | Opole | 45 819 | Poland |
| EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1 | Poznan | 60-309 | Poland |
| Twoja Przychodnia Pcm | Poznan | 60-324 | Poland |
| Endoscopy Limited Liability Company | Sopot | 81-756 | Poland |
| New health-CK, Kieltucki and partners g.p. | Staszów | 28-200 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| H-T. Medical Center | Tychy | 43-100 | Poland |
| Centrum Medyczne Reuma Park | Warsaw | 02-665 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 04-501 | Poland |
| EMC Medical Institute Joint Stock Company, EuroMediCare Specialist Outpatient Clinics in Wroclaw | Wroclaw | 54-144 | Poland |
| ETG Zamość | Zamość | 22-400 | Poland |
| Colentina Clinical Hospital | Bucharest | 020125 | Romania |
| Center of Diagnosis and Treatment Provita | Bucharest | 21494 | Romania |
| Zvezdara University Medical Center | Belgrade | 11 000 | Serbia |
| Clinical Hospital Center Bezanijska Kosa | Belgrade | 11000 | Serbia |
| General Hospital "Djordje Joanovic" | Zrenjanin | 23000 | Serbia |
| Cliniq s.r.o. | Bratislava | 811 09 | Slovakia |
| ENDOMED s.r.o. | Košice | 04013 | Slovakia |
| Gastro LM s.r.o. | Prešov | 08001 | Slovakia |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Yeungnam Univeristy Medical Center | Daegu | 42415 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Changhua Christian Hospital | Changhua | 50006 | Taiwan |
| Chia-Yi Christian Hospital | Chiayi City | 600 | Taiwan |
| Tri-Service General Hospital | Neihu Taipei | 11490 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112201 | Taiwan |
| Far Eastern Memorial Hospital | Taipei | 220 | Taiwan |
| FG002 | MORF-057 100 mg QD-M | Participants received a 100 mg oral dose of MORF-057 once daily in the morning (QD-M) for 12 weeks. |
| FG003 | Placebo | Participants received an oral dose of matching placebo for 12 weeks. |
| Safety Analysis Population | All participants who received at least one dose of the study drug. Participants were analyzed according to the treatment they actually received. |
|
| COMPLETED | Participants who completed the 12-week treatment were considered as 'completed.' |
|
| NOT COMPLETED |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | MORF-057 200 mg BID | Participants received a 200 mg oral dose of MORF-057 twice daily for 12 weeks. |
| BG001 | MORF-057 100 mg BID | Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks. |
| BG002 | MORF-057 100 mg QD-M | Participants received a 100 mg oral dose of MORF-057 once daily in the morning for 12 weeks. |
| BG003 | Placebo | Participants received an oral dose of matching placebo for 12 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants in Clinical Remission as Determined Using the Modified Mayo Clinic Score (mMCS) |
| All randomized participants. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Clinical Response as Determined Using the Modified Mayo Clinic Score (mMCS) |
| All randomized participants. | Posted | Number | percentage of participants | Week 12 |
|
Baseline to Week 12
All participants from the safety analysis population set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MORF-057 200 mg BID | Participants received a 200 mg oral dose of MORF-057 twice daily for 12 weeks. | 0 | 70 | 1 | 70 | 9 | 70 |
| EG001 | MORF-057 100 mg BID | Participants received a 100 mg oral dose of MORF-057 twice daily for 12 weeks. | 0 | 71 | 3 | 71 | 8 | 71 |
| EG002 | MORF-057 100 mg QD-M | Participants received a 100 mg oral dose of MORF-057 once daily in the morning for 12 weeks. | 0 | 70 | 0 | 70 | 5 | 70 |
| EG003 | Placebo | Participants received an oral dose of matching placebo for 12 weeks. | 0 | 69 | 1 | 69 | 10 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (27.1) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (27.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2024 | Sep 18, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Risk Difference (RD) |
| -0.41 |
| 2-Sided |
| 95 |
| -13.99 |
| 13.17 |
| Other |
| Risk Difference (RD) | -6.93 | 2-Sided | 95 | -19.74 | 5.88 | Other |
| OG003 | Placebo | Participants received an oral dose of matching placebo for 12 weeks. |
|
|
|