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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05611671




Registration number
NCT05611671
Ethics application status
Date submitted
31/10/2022
Date registered
10/11/2022
Date last updated
28/06/2024

Titles & IDs
Public title
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
Scientific 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)
Secondary ID [1] 0 0
MORF-057-202
Universal Trial Number (UTN)
Trial acronym
EMERALD-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Diseases 0 0
Colitis, Ulcerative 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MORF-057
Treatment: Drugs - Placebo

Experimental: Group 1 - MORF-057 Dosing Regimen One for Induction and Maintenance Periods

Experimental: Group 2 - MORF-057 Dosing Regimen Two for Induction and Maintenance Periods

Experimental: Group 3 - MORF-057 Dosing Regimen Three for Induction and Maintenance Periods

Placebo comparator: Group 4 - Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance


Treatment: Drugs: MORF-057
MORF-057 is a small molecule that is designed to selectively inhibit integrin a4ß7 and is administered orally.

Treatment: Drugs: Placebo
Matching placebo (identical appearance to MORF-057) administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS).
Timepoint [1] 0 0
From baseline to 12 weeks
Secondary outcome [1] 0 0
Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS)
Timepoint [1] 0 0
From baseline to 12 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Clinical Study Site - Blacktown
Recruitment hospital [2] 0 0
Clinical Study Site - Concord
Recruitment hospital [3] 0 0
Clinical Study Site - Brisbane
Recruitment hospital [4] 0 0
Clinical Study Site - Parkville
Recruitment hospital [5] 0 0
Clinical Study Site - Murdoch
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
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United States of America
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Arizona
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California
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South Carolina
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Texas
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Austria
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Linz
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Austria
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Salzburg
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Vienna
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Bulgaria
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Ruse
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Sofia
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Olomouc
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Prague
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Wadowice
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Iasi
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Serbia
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Taichung
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Taiwan
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Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Morphic Therapeutic, Inc
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT05611671
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Morphic Therapeutic, Inc
Address 0 0
Country 0 0
Phone 0 0
781-996-0955
Fax 0 0
Email 0 0
clinicaltrials@morphictx.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05611671