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

Part of paid clinical trials in Lancaster, California.

Sponsor
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Study ID
NCT06226883
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Matching placebo (identical appearance to MORF-057) administered orally.
  • MORF-057 — DRUG
    MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Study Details

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).

Key Dates

Start date
Jul 18, 2024
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
385 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 (Part A)
    Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
  • Experimental: Group 2 (Part A)
    Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
  • Placebo Comparator: Group 3 (Part A)
    Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
  • Experimental: Group 4 (Part B)
    Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
  • Experimental: Group 5 (Part B)
    Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
  • Placebo Comparator: Group 6 (Part B)
    Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period

Primary Outcome Measure

Proportion of participants with endoscopic response at Week 14 as determined using the Simple Endoscopic Score-CD (SES-CD) [ Time Frame: Baseline to Week 14 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (25)

FacilityCityStateZIPSite coordinators
Gastro Care InstituteLancasterCalifornia93534
661-529-7550
Kumaravel Perumalsamy (PRINCIPAL_INVESTIGATOR)
Infinity Clinical ResearchSan DiegoCalifornia92108
Tommy Yen (PRINCIPAL_INVESTIGATOR)
Peak Gastroenterology Associates - Colorado SpringsColorado SpringsColorado80921
719-362-2266
Prashant Krishnan (PRINCIPAL_INVESTIGATOR)
Clinical Research of OsceolaKissimmeeFlorida34741
407-846-6331
Basher Atiquzzaman (PRINCIPAL_INVESTIGATOR)
Bioresearch Partner-Kendale LakesMiamiFlorida33155
833-489-4968
Keila Hoover (PRINCIPAL_INVESTIGATOR)
Endoscopic Research IncOrlandoFlorida32803
407-241-1726
Marlon Ilagan (PRINCIPAL_INVESTIGATOR)
Tropical Clinical TrialsPalmetto BayFlorida33176
754-946-4172
MIchael Feldman (PRINCIPAL_INVESTIGATOR)
Atlanta Gastroenterology Associates (Part of United Digestive)AtlantaGeorgia30342
404-257-9000
Nitin Gupta (PRINCIPAL_INVESTIGATOR)
Atlanta Gastroenterology Specialists, PCAtlantaGeorgia30024
Steven Thalvinder (Thali) Sangha (PRINCIPAL_INVESTIGATOR)
Tandem Clinical ResearchHoumaLouisiana70360
Conar Fitton (PRINCIPAL_INVESTIGATOR)
SSM Health DePaul Hospital- St. LouisBridgetonMissouri063044
918-880-0676
Yezaz Ghouri (PRINCIPAL_INVESTIGATOR)
Las Vegas Clinical TrialsNorth Las VegasNevada89030
Christian Stone (PRINCIPAL_INVESTIGATOR)
Cross Creek Medical ClinicFayettevilleNorth Carolina28304
920-437-5130
Nitinchandra Desai (PRINCIPAL_INVESTIGATOR)
Peters Medical ResearchHigh PointNorth Carolina27260
336-883-9773
Roy Peters (PRINCIPAL_INVESTIGATOR)
Wake Research AssociatesRaleighNorth Carolina27612
336-613-6908
Lisa Cohen (PRINCIPAL_INVESTIGATOR)
Palmetto Gastroenterology Clinical ResearchSummervilleSouth Carolina29486
843-376-0670
Brett Van Leer-Greenberg (PRINCIPAL_INVESTIGATOR)
Gastrointestinal Associates of Northeast TennesseeJohnson CityTennessee44060
423-208-9073
Chakradhar Reddy (PRINCIPAL_INVESTIGATOR)
GI Alliance - Cedar ParkCedar ParkTexas78613
Junaid Siddiqui (PRINCIPAL_INVESTIGATOR)
North Texas GastroenterologyDentonTexas76210
Vijaya Dasari (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77030
Tugrul Purnak (PRINCIPAL_INVESTIGATOR)
Prime Clinical Research - LewisvilleLewisvilleTexas75067
817-907-7330
Ayodele Osowo (PRINCIPAL_INVESTIGATOR)
Prime Clinical ResearchMansfieldTexas76063
Olufemi Abiodun (PRINCIPAL_INVESTIGATOR)
Tyler Research Institute, LLCTylerTexas75701
903-630-6211
George DuVall (PRINCIPAL_INVESTIGATOR)
Care Access Research - OgdenOgdenUtah84403
Chad Gonzales (PRINCIPAL_INVESTIGATOR)
Gastroenterology Associates of Central VirginiaLynchburgVirginia24502
Larry Clark, Jr. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Lancaster, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Gastro Care Institute· Lancaster, CAInfinity Clinical Research· San Diego, CAPeak Gastroenterology Associates - Colorado Springs· Colorado Springs, COClinical Research of Osceola· Kissimmee, FLBioresearch Partner-Kendale Lakes· Miami, FLEndoscopic Research Inc· Orlando, FL

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