A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (EMERALD-2)
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| ClinicalTrials.gov Identifier: NCT05611671 |
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Recruitment Status :
Recruiting
First Posted : November 10, 2022
Last Update Posted : February 28, 2024
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Sponsor:
Morphic Therapeutic, Inc
Information provided by (Responsible Party):
Morphic Therapeutic, Inc
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Inflammatory Bowel Diseases Colitis, Ulcerative | Drug: MORF-057 Drug: Placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 280 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | October 31, 2022 |
| Estimated Primary Completion Date : | May 2025 |
| Estimated Study Completion Date : | July 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1
MORF-057 Dosing Regimen One for Induction and Maintenance Periods
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Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. |
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Experimental: Group 2
MORF-057 Dosing Regimen Two for Induction and Maintenance Periods
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Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. |
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Experimental: Group 3
MORF-057 Dosing Regimen Three for Induction and Maintenance Periods
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Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. |
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Placebo Comparator: Group 4
Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance
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Drug: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally. Drug: Placebo Matching placebo (identical appearance to MORF-057) administered orally. |
Primary Outcome Measures :
- Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS). [ Time Frame: From baseline to 12 weeks ]mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.
Secondary Outcome Measures :
- Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS) [ Time Frame: From baseline to 12 weeks ]mMCS is a composite of the Mayo endoscopic and Mayo clinic scores, and stool frequency scores.
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05611671
Contacts
| Contact: Morphic Therapeutic, Inc | 781-996-0955 | clinicaltrials@morphictx.com |
Locations
| United States, Arizona | |
| Clinical Study Site | Recruiting |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Clinical Study Site | Recruiting |
| Lancaster, California, United States, 93534 | |
| Clinical Study Site | Recruiting |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Clinical Study Site | Recruiting |
| Kissimmee, Florida, United States, 34741 | |
| Clinical Study Site | Withdrawn |
| Miami, Florida, United States, 33175 | |
| Clinical Study Site | Withdrawn |
| Miramar, Florida, United States, 33027 | |
| Clinical Study Site | Withdrawn |
| Orlando, Florida, United States, 32803 | |
| Clinical Study Site | Recruiting |
| Wellington, Florida, United States, 33414 | |
| United States, Kansas | |
| Clinical Study Site | Recruiting |
| Wichita, Kansas, United States, 67226 | |
| United States, Massachusetts | |
| Clinical Study Site | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| United States, New Jersey | |
| Clinical Study Site | Recruiting |
| Freehold, New Jersey, United States, 07728 | |
| United States, New York | |
| Clinical Study Site | Recruiting |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Clinical Study Site | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Clinical Study Site | Recruiting |
| Mentor, Ohio, United States, 44060 | |
| United States, South Carolina | |
| Clinical Study Site | Withdrawn |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Clinical Study Site | Withdrawn |
| Austin, Texas, United States, 78748 | |
| Clinical Study Site | Recruiting |
| Cedar Park, Texas, United States, 78613 | |
| Clinical Study Site | Recruiting |
| Houston, Texas, United States, 77030 | |
| Australia, New South Wales | |
| Clinical Study Site | Recruiting |
| Blacktown, New South Wales, Australia, 2148 | |
| Clinical Study Site | Recruiting |
| Concord, New South Wales, Australia, 2139 | |
| Australia, Queensland | |
| Clinical Study Site | Recruiting |
| Brisbane, Queensland, Australia, 4029 | |
| Clinical Study Site | Recruiting |
| Brisbane, Queensland, Australia, 4101 | |
| Australia, Victoria | |
| Clinical Study Site | Recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Australia, Western Australia | |
| Clinical Study Site | Recruiting |
| Murdoch, Western Australia, Australia, 6150 | |
Sponsors and Collaborators
Morphic Therapeutic, Inc
| Responsible Party: | Morphic Therapeutic, Inc |
| ClinicalTrials.gov Identifier: | NCT05611671 |
| Other Study ID Numbers: |
MORF-057-202 |
| First Posted: | November 10, 2022 Key Record Dates |
| Last Update Posted: | February 28, 2024 |
| Last Verified: | February 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Morphic Therapeutic, Inc:
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Ulcerative Colitis (UC) Inflammatory Bowel Disease (IBD) a4b7 |
Moderate-to-severe Integrin EMERALD |
Additional relevant MeSH terms:
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Colitis Intestinal Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |