Sponsor: Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
trial.available_in:
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Overview
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).
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.
Who can participate
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
Locations
20
Australia (1)
Blacktown Hospital
Blacktown
Bulgaria (1)
Medical Center "Rusemed" EOOD
Rousse
Czech Republic (1)
PreventaMed, s.r.o.
Olomouc
Estonia (1)
LV Venter OU
Pärnu
France (1)
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice
Georgia (1)
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi
Germany (1)
Charite - University Hospital Berlin
Berlin
Hungary (1)
Semmelweis Medical University
Budapest
India (1)
Fortis Memorial Research Institute(FMRI)
Gurgaon
Israel (1)
Shaare Zedek Medical Center, Digestive Diseases Institute
Jerusalem
Italy (1)
Ospedale Luigi Sacco
Milan
Latvia (1)
Liepaja Regional Hospital
Liepāja
Lithuania (1)
Republican Panevezys Hospital
Panevezys
Poland (1)
CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska