Group 2 for Ulcerative Colitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ulcerative Colitis+1 MoreMORF-057 - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

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).

Eligible Conditions
  • Ulcerative Colitis
  • Inflammatory Bowel Disease

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: From baseline to 12 weeks

Week 12
Change from baseline to Week 12 in clinical response in the Modified Mayo Clinic Score (mMCS)
Proportion of participants in clinical remission at Week 12 as determined using the Modified Mayo Clinic Score (mMCS).

Trial Safety

Trial Design

4 Treatment Groups

Group 2
1 of 4
Group 1
1 of 4
Group 3
1 of 4
Group 4
1 of 4

Experimental Treatment

Non-Treatment Group

280 Total Participants · 4 Treatment Groups

Primary Treatment: Group 2 · Has Placebo Group · Phase 2

Group 2
Drug
Experimental Group · 1 Intervention: MORF-057 · Intervention Types: Drug
Group 1
Drug
Experimental Group · 1 Intervention: MORF-057 · Intervention Types: Drug
Group 3
Drug
Experimental Group · 1 Intervention: MORF-057 · Intervention Types: Drug
Group 4PlaceboComparator Group · 2 Interventions: MORF-057, Placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MORF-057
2020
Completed Phase 1
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to 12 weeks

Who is running the clinical trial?

Morphic Therapeutic, IncLead Sponsor
2 Previous Clinical Trials
107 Total Patients Enrolled

Eligibility Criteria

Age 18 - 85 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have signs/symptoms of moderate to severe UC for at least 3 months prior to Screening.
You have evidence of UC extending at least 15 cm from the anal verge.
You have no prior exposure to approved or investigational anti-integrin therapies.

Who else is applying?

What state do they live in?
Ohio100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Clinical Study Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%