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| ID | Type | Description | Link |
|---|---|---|---|
| J6E-MC-KWAL | Other Identifier | Eli Lilly and Company | |
| MORF-057-201 | Other Identifier | Morphic Therapeutic, Inc | |
| 2024-516960-27-00 | EU Trial (CTIS) Number | ||
| 2021-005288-31 | EudraCT Number |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORF-057 | Experimental | Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 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 |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score | The Modified Mayo Clinic Score (mMCS) is a composite of the following Mayo Clinic Score subscores: Endoscopy subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration), Stool Frequency subscore (range: 0=Normal number of stools for this participant to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The total mMCS ranges from 0 to 9, with higher scores indicating more severe disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Study Site | Tampa | Florida | 33609 | United States | ||
| Clinical Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40769468 | Derived | 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. |
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The study plan included two cohorts. Both cohorts receive the same MORF-057 treatment regimen.
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| ID | Title | Description |
|---|---|---|
| FG000 | MORF-057 (Main Cohort) | Participants received MORF-057 100 milligrams (mg) orally twice daily for up to 78 weeks. |
| FG001 | MORF-057 (Exploratory Cohort) | Participants received MORF-057 100 mg orally twice daily for up to 78 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 | Jul 27, 2023 | Oct 17, 2024 |
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| From baseline to 12 weeks |
| Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057 | To determine the Maximum Plasma Concentration of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose. | 12 weeks |
| Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057 | To determine the Tmax of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose. | 12 weeks |
| Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057 | To determine the area under the concentration-time curve of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose. | 12 weeks |
| 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 |
| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | MORF-057 (Main Cohort) | Participants received MORF-057 100 mg orally twice daily for up to 78 weeks. |
| BG001 | MORF-057 (Exploratory Cohort) | Participants received MORF-057 100 mg orally twice daily for up to 78 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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 | 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) | Main Cohort: All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | score on a scale | From baseline to 12 weeks |
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| Secondary | Main Cohort: Change From Baseline to Week 12 in the Modified Mayo Clinic Score | The Modified Mayo Clinic Score (mMCS) is a composite of the following Mayo Clinic Score subscores: Endoscopy subscore (range: 0=Normal or inactive disease to 3=Severe disease (spontaneous bleeding, ulceration), Stool Frequency subscore (range: 0=Normal number of stools for this participant to 3=5 or more stools more than normal), and Rectal Bleeding subscore (range: 0=No blood seen to 3=Blood alone passed). The total mMCS ranges from 0 to 9, with higher scores indicating more severe disease. | Main Cohort: All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | score on a scale | From baseline to 12 weeks |
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| Secondary | Main Cohort: Maximum Plasma Concentration (Cmax) During Multiple Doses of MORF-057 | To determine the Maximum Plasma Concentration of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose. | Main Cohort: All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 12 weeks |
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| Secondary | Main Cohort: Time to Reach Cmax (Tmax) During Multiple Doses of MORF-057 | To determine the Tmax of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose. | Main Cohort: All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 12 weeks |
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| Secondary | Main Cohort: Area Under the Curve (AUC) Following Multiple Doses of MORF-057 | To determine the area under the concentration-time curve of MORF-057, blood samples were collected per the study protocol at the following time points: Study Day 1 (first dose), predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 2, predose and 1, 2, 3, 4, and 6 hours post the AM dose; Week 6, predose and 1 and 3 hours post the AM dose; Week 12, predose and 1, 2, 3, 4, and 6 hours post the AM dose. On Study Day 1, Week 2, and Week 12, blood sampling for pharmacokinetics was optional at 8, 10, and 12 hours post the AM dose. | Main Cohort: All participants who received at least one dose of study drug and had evaluable data for this outcome. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*ng/mL | 12 weeks |
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From baseline to week 78
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative).
The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE. For each AE, the Investigator will evaluate and report the onset, resolution, severity,causality, action taken, outcomes, and whether or not it caused the participant to discontinue.
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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 (Main Cohort) | Participants received MORF-057 100 mg orally twice daily for up to 78 weeks. | 0 | 35 | 0 | 35 | 19 | 35 |
| EG001 | MORF-057 (Exploratory Cohort) | Participants received MORF-057 100 mg orally twice daily for up to 78 weeks. | 0 | 4 | 0 | 4 | 4 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
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| Bundle branch block right | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Abdominal tenderness | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Intestinal stenosis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Tongue coated | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Tongue discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Diarrhoea infectious | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Glomerular filtration rate decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Skin swelling | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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Per the study protocol: "The results of this study may be published or presented at scientific meetings. If this is foreseen, the Investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission."
| 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 | Oct 23, 2023 | Oct 17, 2024 | SAP_001.pdf |
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| 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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| 65 to 84 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Poland |
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