MORF-057 for Ulcerative Colitis

(EMERALD-2 Trial)

Not currently recruiting at 228 trial locations

Overseen By Morphic Therapeutic, Inc

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Integrin inhibitors

Disqualifiers: Crohn's disease, Indeterminate colitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MORF-057 for individuals with moderately to severely active Ulcerative Colitis (UC), a condition causing long-term inflammation and ulcers in the colon. The study aims to evaluate the safety and effectiveness of three different doses of MORF-057 compared to a placebo (a substance with no active drug). Participants should have experienced UC symptoms for at least 3 months and found that previous treatments were ineffective or problematic. The trial seeks individuals who have not tried certain advanced treatments before. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have had an inadequate response or intolerance to certain treatments, which might imply that you can continue some medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MORF-057 is generally well-tolerated by people with ulcerative colitis. Studies found that 25.7% of those taking MORF-057 experienced significant improvement in their symptoms, known as remission. Importantly, these studies reported that the treatment was safe, with only a few side effects. Early results suggest that MORF-057 could be a safe and effective option for managing ulcerative colitis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Ulcerative Colitis?

Researchers are excited about MORF-057 for ulcerative colitis because it offers a fresh approach compared to the usual treatments like aminosalicylates, corticosteroids, and biologics. Unlike those, MORF-057 targets a specific mechanism called the α4β7 integrin, which plays a crucial role in gut inflammation. This targeted action could potentially reduce inflammation more effectively and with fewer side effects. Additionally, MORF-057's different dosing regimens aim to optimize both the induction of remission and its maintenance, which could provide long-lasting relief for patients.

What evidence suggests that MORF-057 might be an effective treatment for Ulcerative Colitis?

Research has shown that MORF-057, which participants in this trial may receive, may help treat ulcerative colitis. In one study, 25.7% of patients showed improvement in their gut lining, and 45.7% experienced better symptoms after 12 weeks. Another study found that 22.9% of participants had a significant reduction in symptoms. These early results suggest that MORF-057 could be an effective pill for people with moderately to severely active ulcerative colitis. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18-85 with moderately to severely active Ulcerative Colitis (UC) who haven't responded well to certain UC treatments can join. They must not have used anti-integrin therapies before and should be able to follow study rules. People with a history of cancer in the last 5 years, unstable health conditions, or previous use of MORF-057 or similar drugs cannot participate.

Inclusion Criteria

I have had moderate to severe ulcerative colitis symptoms for at least 3 months.

I have had moderate to severe ulcerative colitis symptoms for at least 3 months.

I am able to understand and sign the consent form.

Exclusion Criteria

You cannot be participating in another study or have received any experimental treatment within the past 30 days.

I have not had colorectal or any cancer in the last 5 years.

I have been diagnosed with a specific type of colitis or have symptoms that may suggest Crohn's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive one of three active dose regimens of MORF-057 or placebo for 12 weeks

12 weeks

Maintenance

Participants may switch to a different active MORF-057 regimen; placebo group switches to active regimen

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MORF-057
• Placebo

Trial Overview The trial is testing three doses of MORF-057 against a placebo in adults with UC. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real treatment versus the placebo until after results are collected.

How Is the Trial Designed?

Group I: Group 3 Experimental Treatment 1 Intervention

MORF-057 Dosing Regimen Three for Induction and Maintenance Periods

Group II: Group 2 Experimental Treatment 1 Intervention

MORF-057 Dosing Regimen Two for Induction and Maintenance Periods

Group III: Group 1 Experimental Treatment 1 Intervention

MORF-057 Dosing Regimen One for Induction and Maintenance Periods

Group IV: Group 4 Placebo Group 2 Interventions

Matching Placebo Dosing Regimen for Induction and MORF-057 Dosing Regimen Four for Maintenance

Who Is Running the Clinical Trial?

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

Lead Sponsor

Morphic Therapeutic, Inc

Lead Sponsor

Trials

4

Recruited

590+

Published Research Related to This Trial

The newer formulations of 5-aminosalicylic acid (5-ASA) were found to be significantly more effective than placebo in inducing remission in active ulcerative colitis, with a pooled odds ratio of 0.51, indicating a lower failure rate in achieving clinical improvement.

While 5-ASA showed a trend towards better outcomes compared to sulfasalazine (SASP), the difference was not statistically significant, and 5-ASA was better tolerated, suggesting it may be a preferable option despite potential cost considerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral 5-aminosalicylic acid for inducing remission in ulcerative colitis. Sutherland, L., Roth, D., Beck, P., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40769468/

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ... Additionally, 22.9% of participants (8/35) achieved RHI remission (RHI score ≤3). In participants with evaluable data (n = 18), the effects of ...

2. cghjournal.org cghjournal.org/article/S1542-3565(25)00648-2/fulltext

A Phase 2 Study of MORF-057, an Oral α4β7 Integrin ... These initial results suggest that MORF-057 is a potentially safe and effective advanced oral therapy for ulcerative colitis, suitable for ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07186101

Study Details | NCT07186101 | LY4268989 (MORF-057) ... The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult ...

4. hcplive.com hcplive.com/view/-of-patients-achieve-endoscopic-remission-in-phase-2a-emerald-1-trial-for-morf-057

25% of Patients Achieve Endoscopic Remission in Phase ... Data from the phase 2a trial showed 25.7% of patients with UC demonstrated endoscopic improvement and 45.7% achieved clinical response after week 12.

5. crohnscolitisfoundation.org crohnscolitisfoundation.org/a-phase-2b-randomized-double-blind-placebo-controlled-study-to-evaluate-the-safety-and-efficacy-of

A Phase 2b, Randomized, Double-blind, Placebo ... The purpose of this study is to evaluate the safety and efficacy of the investigational drug MORF-057 in participants with moderately to severely active ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05291689

NCT05291689 | A Phase 2a Open-Label Study to Evaluate ... This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately ...

7. biospace.com biospace.com/morphic-reports-positive-topline-results-of-the-emerald-1-uc-main-cohort-orally-administered-morf-057-achieves-primary-endpoint-and-demonstrates-clinically-meaningful-improvements-across-secondary-and-exploratory-measures

Morphic Reports Positive Topline Results of the EMERALD ... In the study, patients receiving MORF-057 experienced a 25.7% remission rate according to mMCS. MORF-057 was generally well tolerated at the ...

8. trial.medpath.com trial.medpath.com/clinical-trial/66402d0b7335d3c1/2024-516960-27-00-morf-057-ulcerative-colitis-efficacy-safety

A Phase 2a study to evaluate the Efficacy, Safety ... - MedPath A Phase 2a study to evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Ulcerative Colitis ... Outcome data and publication updates. Subscribe.