A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC

Last updated: April 1, 2025
Sponsor: Morphic Therapeutic, Inc
Overall Status: Active - Not Recruiting

Phase

2

Condition

Inflammatory Bowel Disease

Crohn's Disease

Gastrointestinal Diseases And Disorders

Treatment

MORF-057

Placebo

Clinical Study ID

NCT05611671
MORF-057-202
  • Ages 18-85
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 leastone 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

Exclusion Criteria:

  • Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis,radiation colitis, or Crohn's disease or has clinical findings suggestive of Crohn'sdisease

  • 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 integrininhibitors

  • Participation in any other interventional study or received any investigationaltherapy within 30 days

  • Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with asimilar mechanism to MORF-057

  • Unable to attend study visits or comply with study procedures

Study Design

Total Participants: 282
Treatment Group(s): 2
Primary Treatment: MORF-057
Phase: 2
Study Start date:
October 31, 2022
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Clinical Study Site

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Clinical Study Site

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Clinical Study Site

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Clinical Study Site

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Clinical Study Site

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • Clinical Study Site

    Perth, Western Australia 6150
    Australia

    Site Not Available

  • Clinical Study Site

    Linz, 4010
    Austria

    Site Not Available

  • Clinical Study Site

    Salzburg, 5020
    Austria

    Site Not Available

  • Clinical Study Site

    Vienna, 1090
    Austria

    Site Not Available

  • Clinical Study Site

    Ruse, 7005
    Bulgaria

    Site Not Available

  • Clinical Study Site

    Sofia, 1784
    Bulgaria

    Site Not Available

  • Clinical Study Site

    Olomouc, 779 00
    Czechia

    Site Not Available

  • Clinical Study Site

    Prague, 140 00
    Czechia

    Site Not Available

  • Clinical Study Site

    Slaný, 274 01
    Czechia

    Site Not Available

  • Clinical Study Site

    Pärnu, 80010
    Estonia

    Site Not Available

  • Clinical Study Site

    Tallinn, 10138
    Estonia

    Site Not Available

  • Clinical Study Site

    Tartu, 50406
    Estonia

    Site Not Available

  • Clinical Study Site

    Lille, 59037
    France

    Site Not Available

  • Clinical Study Site

    Nice, 06200
    France

    Site Not Available

  • Clinical Study Site

    Pierre-Bénite, 69495
    France

    Site Not Available

  • Clinical Study Site

    Saint-Priest-en-Jarez, 42270
    France

    Site Not Available

  • Clinical Study Site

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

  • Clinical Study Site

    Tbilisi, 0180
    Georgia

    Site Not Available

  • Clinical Study Site

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Site Not Available

  • Clinical Study Site

    Tuebingen, Baden-Wuerttemberg 72076
    Germany

    Site Not Available

  • Clinical Study Site

    Ulm, Baden-Wuerttemberg 89081
    Germany

    Site Not Available

  • Clinical Study Site

    Regensburg, Bavaria 93053
    Germany

    Site Not Available

  • Clinical Study Site

    Cologne, North Rhine-Westphalia 51103
    Germany

    Site Not Available

  • Clinical Study Site

    Münster, North Rhine-Westphalia 48149
    Germany

    Site Not Available

  • Clinical Study Site

    Leipzig, Saxony 04103
    Germany

    Site Not Available

  • Clinical Study Site

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Clinical Study Site

    Berlin, 14163
    Germany

    Site Not Available

  • Clinical Study Site

    Budapest, H-1088
    Hungary

    Site Not Available

  • Clinical Study Site

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Clinical Study Site

    Szekesfehervar, H-8000
    Hungary

    Site Not Available

  • Clinical Study Site

    Vac, H-2600
    Hungary

    Site Not Available

  • Clinical Study Site

    New Delhi, Delhi 110025
    India

    Site Not Available

  • Clinical Study Site

    Surat, Gujarat 395002
    India

    Site Not Available

  • Clinical Study Site

    Gurgaon, Haryana 122002
    India

    Site Not Available

  • Clinical Study Site

    Thiruvananthapuram, Kerala 695011
    India

    Site Not Available

  • Clinical Study Site

    Ludhiana, Punjab 141001
    India

    Site Not Available

  • Clinical Study Site

    Jaipur, Rajasthan 302006
    India

    Site Not Available

  • Clinical Study Site

    Hyderabad, Telangana 500004
    India

    Site Not Available

  • Clinical Study Site

    Secunderabad, Telangana 500003
    India

    Site Not Available

  • Clinical Study Site

    Noida, Uttar Pradesh 201301
    India

    Site Not Available

  • Clinical Study Site

    Delhi, 110029
    India

    Site Not Available

  • Clinical Study Site

    Be'er Sheva, 8410101
    Israel

    Site Not Available

  • Clinical Study Site

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Clinical Study Site

    Nahariya, 2210001
    Israel

    Site Not Available

  • Clinical Study Site

    Reẖovot, 7661041
    Israel

    Site Not Available

  • Clinical Study Site

    Florence, 50134
    Italy

    Site Not Available

  • Clinical Study Site

    Milan, 20132
    Italy

    Site Not Available

  • Clinical Study Site

    Padova, 35128
    Italy

    Site Not Available

  • Clinical Study Site

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • Clinical Study Site

    Turin, 10128
    Italy

    Site Not Available

  • Clinical Study Site

    Busan, 49241
    Korea, Republic of

    Site Not Available

  • Clinical Study Site

    Daegu, 42415
    Korea, Republic of

    Site Not Available

  • Clinical Study Site

    Gyeonggi-do, 16247
    Korea, Republic of

    Site Not Available

  • Clinical Study Site

    Seongnam-si, 13496
    Korea, Republic of

    Site Not Available

  • Clinical Study Site

    Seoul, 02447
    Korea, Republic of

    Site Not Available

  • Clinical Study Site

    Liepaja, LV-3414
    Latvia

    Site Not Available

  • Clinical Study Site

    Riga, LV-1002
    Latvia

    Site Not Available

  • Clinical Study Site

    Panevezys, 35144
    Lithuania

    Site Not Available

  • Clinical Study Site

    Vilnius, LT-08661
    Lithuania

    Site Not Available

  • Clinical Study Site

    Bydgoszcz, 85-794
    Poland

    Site Not Available

  • Clinical Study Site

    Elbląg, 82-300
    Poland

    Site Not Available

  • Clinical Study Site

    Kraków, 31-501
    Poland

    Site Not Available

  • Clinical Study Site

    Lublin, 20-412
    Poland

    Site Not Available

  • Clinical Study Site

    Opole, 45-819
    Poland

    Site Not Available

  • Clinical Study Site

    Poznan, 60-309
    Poland

    Site Not Available

  • Clinical Study Site

    Sopot, 81-756
    Poland

    Site Not Available

  • Clinical Study Site

    Staszów, 28-200
    Poland

    Site Not Available

  • Clinical Study Site

    Szczecin, 71-434
    Poland

    Site Not Available

  • Clinical Study Site

    Tychy, 43-100
    Poland

    Site Not Available

  • Clinical Study Site

    Wadowice, 40-748
    Poland

    Site Not Available

  • Clinical Study Site

    Warsaw, 02-665
    Poland

    Site Not Available

  • Clinical Study Site

    Wroclaw, 54-144
    Poland

    Site Not Available

  • Clinical Study Site

    Zamość, 22-400
    Poland

    Site Not Available

  • Clinical Study Site

    Łódź, 90-752
    Poland

    Site Not Available

  • Clinical Study Site

    Bucharest, 010825
    Romania

    Site Not Available

  • Clinical Study Site

    Iaşi, 700506
    Romania

    Site Not Available

  • Clinical Study Site

    Belgrade, 11 080
    Serbia

    Site Not Available

  • Clinical Study Site

    Pančevo, 260 00
    Serbia

    Site Not Available

  • Clinical Study Site

    Zrenjanin, 23 000
    Serbia

    Site Not Available

  • Clinical Study Site

    Bratislava, 811 09
    Slovakia

    Site Not Available

  • Clinical Study Site

    Košice, 040 13
    Slovakia

    Site Not Available

  • Clinical Study Site

    Prešov, 080 01
    Slovakia

    Site Not Available

  • Clinical Study Site

    Changhua City, 500209
    Taiwan

    Site Not Available

  • Clinical Study Site

    Chiayi City, 60002
    Taiwan

    Site Not Available

  • Clinical Study Site

    New Taipei City, 220
    Taiwan

    Site Not Available

  • Clinical Study Site

    Taichung, 404327
    Taiwan

    Site Not Available

  • Clinical Study Site

    Taipei, 112201
    Taiwan

    Site Not Available

  • Clinical Study Site

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Clinical Study Site

    Lancaster, California 93534
    United States

    Site Not Available

  • Clinical Study Site

    Los Angeles, California 90048
    United States

    Site Not Available

  • Clinical Study Site

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Clinical Study Site

    Miami, Florida 33175
    United States

    Site Not Available

  • Clinical Study Site

    Miramar, Florida 33027
    United States

    Site Not Available

  • Clinical Study Site

    Orlando, Florida 32803
    United States

    Site Not Available

  • Clinical Study Site

    Wellington, Florida 33414
    United States

    Site Not Available

  • Clinical Study Site

    Wichita, Kansas 67226
    United States

    Site Not Available

  • Clinical Study Site

    Witchita, Kansas 67226
    United States

    Site Not Available

  • Clinical Study Site

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Clinical Study Site

    Freehold, New Jersey 07728
    United States

    Site Not Available

  • Clinical Study Site

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Clinical Study Site

    New York, New York 10016
    United States

    Site Not Available

  • Clinical Study Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Clinical Study Site

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Clinical Study Site

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Clinical Study Site

    Austin, Texas 78748
    United States

    Site Not Available

  • Clinical Study Site

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • Clinical Study Site

    Houston, Texas 77030
    United States

    Site Not Available

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