A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

Last updated: March 28, 2025
Sponsor: Morphic Therapeutic, Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Crohn's Disease

Ulcerative Colitis

Inflammatory Bowel Disease

Treatment

Placebo

MORF-057

Clinical Study ID

NCT06226883
MORF-057-203
  • Ages 18-85
  • All Genders

Study Summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 2 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Has signs/symptoms of CD for at least 3 months prior to Screening

  • Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 pointsand/or an average daily abdominal pain subscore of ≥2 points

  • Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)

  • Demonstrated an inadequate response, loss of response, or intolerance to at leastone of the following treatments: Corticosteroids, Immunosuppressants (eg,azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg,biologic agents, Janus kinase [JAK] inhibitors, applicable investigational products)

  • Agrees to abide by the study guidelines and requirements

  • Capable of giving signed informed consent

Exclusion

Key Exclusion Criteria:

  • Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis,radiation colitis, or UC, or has clinical findings suggestive of UC

  • Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianalregion, without colonic or ileal involvement

  • Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/orhas a known diagnosis of short bowel syndrome

  • Is currently receiving total parenteral nutrition, tube feeding, or a formula diet

  • 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

  • Is currently participating in any other interventional study or has received anyinvestigational therapy 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: 210
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 04, 2024
Estimated Completion Date:
June 30, 2028

Study Description

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of induction therapy with 2 active dose regimens of MORF-057 versus matching placebo in adult study participants with moderately to severely active CD. After completion of the 14-week Induction Period, all participants will receive open-label MORF-057 during the 38-week Maintenance Period. All participants who complete the full 52-week Treatment Period will also have the opportunity to continue treatment in a 52-week Maintenance Extension.

Connect with a study center

  • Clinical Study Site

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Clinical Study Site

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Clinical Study Site

    St. Poelten, 3100
    Austria

    Active - Recruiting

  • Clinical Study Site

    Vienna, 1090
    Austria

    Active - Recruiting

  • Clinical Study Site

    Sao Paulo, 04543-011
    Brazil

    Active - Recruiting

  • Clinical Study Site

    Toronto, Ontario M5T 3A9
    Canada

    Active - Recruiting

  • Clinical Study Site

    Woodbridge, Ontario L4L 4Y7
    Canada

    Active - Recruiting

  • Clinical Study Site

    Calgary, T2N 1N4
    Canada

    Active - Recruiting

  • Clinical Study Site

    Halifax, B3H 1V7
    Canada

    Active - Recruiting

  • Clinical Study Site

    London, N6A 4L6
    Canada

    Active - Recruiting

  • Clinical Study Site

    Montreal, G1V 4T3
    Canada

    Active - Recruiting

  • Clinical Study Site

    Armenia, 630004
    Colombia

    Active - Recruiting

  • Clinical Study Site

    Barranquilla, 083001
    Colombia

    Site Not Available

  • Clinical Study Site

    Cali, 760032
    Colombia

    Active - Recruiting

  • Clinical Study Site

    Floridablanca, 681017
    Colombia

    Active - Recruiting

  • Clinical Study Site

    Medellin, 050012
    Colombia

    Active - Recruiting

  • Clinical Study Site

    Soledad, 083001
    Colombia

    Active - Recruiting

  • Clinical Study Site

    Osijek, 31000
    Croatia

    Active - Recruiting

  • Clinical Study Site

    Rijeka, 51000
    Croatia

    Active - Recruiting

  • Clinical Study Site

    Virovitica, 33000
    Croatia

    Active - Recruiting

  • Clinical Study Site

    Zadar, 23 000
    Croatia

    Active - Recruiting

  • Clinical Study Site

    Zagreb, 10000
    Croatia

    Active - Recruiting

  • Clinical Study Site

    Brno, 615 00
    Czech Republic

    Active - Recruiting

  • Clinical Study Site

    Prague, 140 00
    Czech Republic

    Active - Recruiting

  • Clinical Study Site

    Brno, 615 00
    Czechia

    Active - Recruiting

  • Clinical Study Site

    Prague, 140 00
    Czechia

    Active - Recruiting

  • Clinical Study Site

    Pierre-Benite, 69310
    France

    Active - Recruiting

  • Clinical Study Site

    Saint-Priest-en-Jarez, 42270
    France

    Active - Recruiting

  • Clinical Study Site

    Vandoeuvre-les-Nancy, 54500
    France

    Active - Recruiting

  • Clinical Study Site

    Batumi, 6010
    Georgia

    Active - Recruiting

  • Clinical Study Site

    Tbilisi, 0180
    Georgia

    Active - Recruiting

  • Clinical Study Site 2

    Tbilisi, 0159
    Georgia

    Active - Recruiting

  • Clinical Study Site

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Active - Recruiting

  • Clinical Study Site

    Halle, Saxony-Anhalt 06120
    Germany

    Active - Recruiting

  • Clinical Study Site

    Berlin, 10629
    Germany

    Active - Recruiting

  • Clinical Study Site

    Dachau, 85221
    Germany

    Active - Recruiting

  • Clinical Study Site

    Duisburg, 47055
    Germany

    Active - Recruiting

  • Clinical Study Site

    Kiel, 24105
    Germany

    Active - Recruiting

  • Clinical Study Site

    Ulm, 89081
    Germany

    Active - Recruiting

  • Clinical Study Site

    Wipperfurth, 51688
    Germany

    Active - Recruiting

  • Clinical Study Site

    Bekescsaba, H-5600
    Hungary

    Active - Recruiting

  • Clinical Study Site

    Budapest, H-7100
    Hungary

    Active - Recruiting

  • Clinical Study Site

    Eger, H-3300
    Hungary

    Active - Recruiting

  • Clinical Study Site

    Gyongyos, 3200
    Hungary

    Active - Recruiting

  • Clinical Study Site

    Szekesfehervar, H-8000
    Hungary

    Active - Recruiting

  • Clinical Study Site

    Szekszárd, H-7100
    Hungary

    Active - Recruiting

  • Clinical Study Site

    Kochi, Kerala 682041
    India

    Active - Recruiting

  • Clinical Study Site

    Pune, Maharashtra 411013
    India

    Active - Recruiting

  • Clinical Study Site

    Chennai, Tamil Nadu 600035
    India

    Active - Recruiting

  • Clinical Study Site

    Varanasi, Uttar Pradesh 221005
    India

    Active - Recruiting

  • Clinical Study Site

    Ahmedabad, 380009
    India

    Active - Recruiting

  • Clinical Study Site

    Gujarat, 360001
    India

    Site Not Available

  • Clinical Study Site

    Jaipur, 302006
    India

    Active - Recruiting

  • Clinical Study Site

    Rajkot, 360005
    India

    Active - Recruiting

  • Clinical Study Site

    Rājkot, 360001
    India

    Active - Recruiting

  • Clinical Study Site

    Secunderabad, 500003
    India

    Active - Recruiting

  • Clinical Study Site

    Bologna, 40138
    Italy

    Active - Recruiting

  • Clinical Study Site

    Milan, 20162
    Italy

    Active - Recruiting

  • Clinical Study Site

    Negrar, 37024
    Italy

    Active - Recruiting

  • Clinical Study Site

    Rome, 00151
    Italy

    Active - Recruiting

  • Clinical Study Site

    Rozzano, 20089
    Italy

    Active - Recruiting

  • Clinical Study Site

    San Donato Milanese, 20097
    Italy

    Active - Recruiting

  • Clinical Study Site

    San Giovanni Rotondo, 71013
    Italy

    Active - Recruiting

  • Clinical Study Site

    Udine, 33100
    Italy

    Active - Recruiting

  • Clinical Study Site

    Almaty, 050000
    Kazakhstan

    Active - Recruiting

  • Clinical Study Site

    Astana, 010000
    Kazakhstan

    Active - Recruiting

  • Clinical Study Site

    Karaganda, 100000
    Kazakhstan

    Active - Recruiting

  • Clinical Study Site

    Semey, 071400
    Kazakhstan

    Active - Recruiting

  • Clinical Study Site

    Shymkent, 160005
    Kazakhstan

    Active - Recruiting

  • Clinical Study Site

    Riga, LV-1002
    Latvia

    Active - Recruiting

  • Clinical Study Site

    Durango, 34000
    Mexico

    Active - Recruiting

  • Clinical Study Site

    Bydgoszcz, 85-229
    Poland

    Active - Recruiting

  • Clinical Study Site

    Czestochowa, 42-202
    Poland

    Active - Recruiting

  • Clinical Study Site

    Elblag, 82-300
    Poland

    Active - Recruiting

  • Clinical Study Site

    Elbląg, 82-300
    Poland

    Active - Recruiting

  • Clinical Study Site

    Gdansk, 80-382
    Poland

    Active - Recruiting

  • Clinical Study Site

    Katowice, 40-748
    Poland

    Active - Recruiting

  • Clinical Study Site

    Kraków, 31-156
    Poland

    Active - Recruiting

  • Clinical Study Site

    Opole, 45-819
    Poland

    Active - Recruiting

  • Clinical Study Site

    Poznan, 60-309
    Poland

    Active - Recruiting

  • Clinical Study Site

    Sopot, 81-756
    Poland

    Active - Recruiting

  • Clinical Study Site

    Szczecin, 71-434
    Poland

    Active - Recruiting

  • Clinical Study Site

    Tychy, 43-100
    Poland

    Active - Recruiting

  • Clinical Study Site

    Warsaw, 02-672
    Poland

    Active - Recruiting

  • Clinical Study Site

    Wroclaw, 52-416
    Poland

    Active - Recruiting

  • Clinical Study Site

    Bucharest, 011273
    Romania

    Active - Recruiting

  • Clinical Study Site

    Constanta,
    Romania

    Active - Recruiting

  • Clinical Study Site

    Timişoara, 300239
    Romania

    Active - Recruiting

  • Clinical Study Site

    Belgrade, 11080
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Kragujevac, 34 000
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Leskovac, 16000
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Novi Sad, 21137
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Uzice, 31000
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Zrenjanin, 23 000
    Serbia

    Active - Recruiting

  • Clinical Study Site

    Bratislava, 811 09
    Slovakia

    Active - Recruiting

  • Clinical Study Site

    Kosice, 040 13
    Slovakia

    Active - Recruiting

  • Clinical Study Site

    Presov, 080 01
    Slovakia

    Active - Recruiting

  • Clinical Study Site

    A Coruna, 15405
    Spain

    Active - Recruiting

  • Clinical Study Site

    Leon, 24071
    Spain

    Active - Recruiting

  • Clinical Study Site

    Lleida, 25196
    Spain

    Active - Recruiting

  • Clinical Study Site

    Madrid, 28222
    Spain

    Active - Recruiting

  • Clinical Study Site

    Seville, 41009
    Spain

    Active - Recruiting

  • Clinical Study Site

    Valencia, 46026
    Spain

    Active - Recruiting

  • Clinical Study Site

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Clinical Study Site

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

  • Clinical Study Site

    Raleigh, North Carolina 27612
    United States

    Active - Recruiting

  • Clinical Study Site

    Summerville, South Carolina 29486
    United States

    Active - Recruiting

  • Clinical Study Site

    Johnson City, Tennessee 37604
    United States

    Active - Recruiting

  • Clinical Study Site

    Cedar Park, Texas 78613
    United States

    Active - Recruiting

  • Clinical Study Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Clinical Study Site

    Southlake, Texas 78666
    United States

    Active - Recruiting

  • Clinical Study Site

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Clinical Study Site

    Ogden, Utah 84403
    United States

    Active - Recruiting

  • Clinical Study Site

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

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