A Phase 2b Study to Evaluate MORF-057 in Adults with Moderately to Severely Active UC

Phase 1

Recruiting

• Conditions: Moderately to severely active ulcerative colitis; MedDRA version: 20.1Level: LLTClassification code: 10045365Term: Ulcerative colitis Class: 10017947; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2022-500953-17-00
• Lead Sponsor: Morphic Therapeutic Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-23
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

Male or female, 18 to 85 years of age, inclusive, at the time of signing the Informed Consent Form (ICF)., A participant is eligible to participate if he/she agrees to abide by the guidelines set forth in this protocol regarding contraception requirements a. A male participant is eligible to participate if he agrees to the following during the study Treatment Period and for at least 28 days after receiving the last dose of MORF-057: • Abstains from heterosexual intercourse as his preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR • Agrees to use contraception/barrier methods as detailed below: o Agrees to use a male condom, with female partner use of an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. b. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • Is a woman of non-childbearing potential OR • Is a woman of childbearing potential and agrees to use a contraceptive method that is highly effective with a failure rate of <1% per year during the study Treatment Period and for at least 28 days after receiving the last dose of MORF-057, For the study Treatment Period and at least 14 days after receiving the last dose of MORF-057, male participants must agree not to donate sperm and female participants must agree not to donate eggs (ova, oocytes)., Capable of giving signed informed consent,which includes compliance with the requirements and restrictions listed in the ICF and in this protocol, Participant has had diagnosis of UC supported by signs/symptoms, endoscopy, and histology for at least 3 months prior to Screening. Moderately to severely active UC was determined during the Screening Period with the following criteria: an mMCS of 5 to 9 (inclusive), with an MES =2 (confirmed by central reader), 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 (including oral aminosalicylates, corticosteroids, immunosuppressants, and/or advanced therapies for UC) in the opinion of the Investigator : 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, JAK antagonists, or sphingosine-1-phosphate [S1P] receptor agonists), Meets the following washout criteria of prior UC therapy relative to study Day 1: a. TNF antagonists: at least 8 weeks b. IL-12/IL-23 antagonists, including ustekinumab: at least 8 weeks c. JAK antagonists, including tofacitinib or upadacitinib: at least 1 week d. S1P receptor agonists, including ozanimod: at least 4 weeks, If the participant has been receiving any of the non-prohibited medications for UC listed below, he/she must discontinue use at least 5 half-lives before study Day 1 or must agree to maintain stable doses of these concomitant medications starting from the time specified below until the end of the SFU Period, with the exception of tapering oral corticosteroid dose after 12 weeks of being in the trial. a. Oral 5-Aminosalicylates (not exceeding 4.8 g per day): at least 2 weeks prior to study Day 1 b. Oral corticosteroids (not exceeding predn

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, Had any vaccination (including live virus vaccinations) within 3 weeks prior to study Day 1., Has a concurrent, clinically significant, serious, unstable comorbidity (such as uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder) that, in the judgement of the Investigator, would compromise compliance with the protocol, interfere with interpretation of the study results, or pre-dispose participants to safety risks, Has a known primary or secondary immunodeficiency, Has a history of myocardial infarction, unstable angina, transient ischemic attack, decompensated heart failure requiring hospitalization, congestive heart failure (New York Heart Association Class 3 or 4), uncontrolled arrhythmias, cardiac revascularization, uncontrolled hypertension, or uncontrolled diabetes within 6 months of Screening, Has a history of left ventricular ejection fraction (LVEF) <50%, Has a clinically significant abnormal ECG at Screening, including a QT interval corrected through use of Fridericia’s formula (QTcF) =450 ms for males and =470 ms for females, Abnormal hematology (hemoglobin level, WBC count, or platelet count) or coagulation results at Screening, as evidenced by the ranges: a.Hemoglobin level <8.0 g/dL b.Absolute WBC count <3.0 × 10^9/L c.Absolute lymphocyte count <0.5 × 10^9/L d.Absolute lymphocyte count >5.5 x 10^9/L e.Absolute neutrophil count <1.2 × 10^9/L f.Platelet count <100 × 10^9/L or >1000 × 10^9/L g.International normalized ratio >1.5. Participants with an international normalized ratio >1.5 due to anticoagulant therapy (e.g., warfarin) may only be enrolled after a consultation with the Medical Monitor., Clinically significant abnormal urinalysis results, as deemed by the Investigator or designee, Abnormal organ function at Screening, as evidenced by: a.Alanine aminotransferase or aspartate aminotransferase >2.0 × upper limit of normal (ULN) b.Chronic kidney disease stages 4 and 5, defined as having a glomerular filtration rate <30 mL/min/1.73m2 as calculated using the Modification of Diet in Renal Disease equation, receiving dialysis, or being listed for or has received a renal transplant c.Total bilirubin =1.5 × ULN, History of active malignancy in the 5 years preceding study Day 1, except in cases of basal cell skin cancer, squamous cell skin cancer, or other in-situ malignancies that have been excised and resolved and the participant was deemed clear of cancer after appropriate follow-up. Participants with a history of malignancy or those at high risk for malignancy may only be enrolled after a consultation with the Medical Monitor., Has current evidence of un-resected colonic dysplasia or un-resected adenomatous colonic polyps or evidence of toxic megacolon, abdominal abscess, symptomatic colonic stricture, fistula, stoma, ileostomy, or colostomy at Screening, Treatment with cyclosporine, mycophenolate, tacrolimus, or sirolimus within 30 days or 5 half-lives (whichever is shorter) prior to study Day 1, Any previous treatment with vedolizumab or other licensed or investigational integrin inhibitors, Experiencing toxicities from prior therapy with Grade >1 within 1 week prior to first dose of study drug, Fecal microbiota transplanta

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified