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

Purpose

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).

Conditions

  • Inflammatory Bowel Diseases
  • Crohn's Disease

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 points and/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 least one 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 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 perianal region, without colonic or ileal involvement - Has had extensive bowel resection (>100 cm), and/or more than 3 resections, and/or has 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 integrin inhibitors - Is currently participating in any other interventional study or has 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1 		Blinded MORF-057 Dosing Regimen 1 for Induction Period and open-label MORF-057 for Maintenance Period
  • Drug: MORF-057
    MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Experimental
Group 2 		Blinded MORF-057 Dosing Regimen 2 for Induction Period and open-label MORF-057 for Maintenance Period
  • Drug: MORF-057
    MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.
Placebo Comparator
Group 3 		Blinded matching placebo for Induction Period and open-label MORF-057 for Maintenance Period
  • Drug: Placebo
    Matching placebo (identical appearance to MORF-057) administered orally.
  • Drug: MORF-057
    MORF-057 is a small molecule that is designed to selectively inhibit integrin α4β7 and is administered orally.

Recruiting Locations

Gastro Care Institute
Lancaster 5364940, California 5332921 93534
Contact:
661-529-7550

Wake Research Associates
Raleigh 4487042, North Carolina 4482348 27612
Contact:
336-613-6908

Palmetto Gastroenterology Clinical Research
Summerville 4597919, South Carolina 4597040 29486
Contact:
843-376-0670

Gastrointestinal Associates of Northeast Tennessee
Johnson City 4633419, Tennessee 4662168 44060
Contact:
423-208-9073

GI Alliance - Cedar Park
Cedar Park 4679867, Texas 4736286 78613

Tyler Research Institute, LLC
Tyler 4738214, Texas 4736286 75701
Contact:
903-630-6211

Care Access Research - Ogden
Ogden 5779206, Utah 5549030 84403

Gastroenterology Associates of Central Virginia
Lynchburg 4771075, Virginia 6254928 24502

More Details

Status
Recruiting
Sponsor
Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Detailed 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.