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A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC (EMERALD-2)

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ClinicalTrials.gov Identifier: NCT05611671
Recruitment Status : Recruiting
First Posted : November 10, 2022
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
Morphic Therapeutic, Inc

Tracking Information
First Submitted Date  ICMJE October 31, 2022
First Posted Date  ICMJE November 10, 2022
Last Update Posted Date May 16, 2024
Actual Study Start Date  ICMJE October 31, 2022
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2022)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2022)		 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
Official Title  ICMJE 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)
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammatory Bowel Diseases
  • Colitis, Ulcerative
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Group 1
    MORF-057 Dosing Regimen One for Induction and Maintenance Periods
    Intervention: Drug: MORF-057
  • Experimental: Group 2
    MORF-057 Dosing Regimen Two for Induction and Maintenance Periods
    Intervention: Drug: MORF-057
  • Experimental: Group 3
    MORF-057 Dosing Regimen Three for Induction and Maintenance Periods
    Intervention: Drug: MORF-057
  • Placebo Comparator: Group 4
    Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance
    Interventions:
    • Drug: MORF-057
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2022)		 280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Morphic Therapeutic, Inc 781-996-0955 clinicaltrials@morphictx.com
Listed Location Countries  ICMJE Australia,   Austria,   Bulgaria,   Czechia,   Estonia,   France,   Georgia,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Poland,   Romania,   Serbia,   Slovakia,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05611671
Other Study ID Numbers  ICMJE MORF-057-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Morphic Therapeutic, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Morphic Therapeutic, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Morphic Therapeutic, Inc
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP