2024-516960-27-00已完成2 期
A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Tolerability of MORF-057 in Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-1)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score.
研究概览
简要总结
To evaluate the effects of MORF-057 on histologic improvement at Week 12
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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 obide by the guidelines set forth in this protocol regarding contraception requirements.
- •For the study Treatment Period and at least 28 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.
- •Exploratory Cohort: Those intolerant to (e.g. infusion-related skin reaction, allergy, or side effects unrelated to α4β7 inhibition) or secondary non-responders to vedolizumab who have been dosed within the past 5 years with the drug.
- •Exploratory Cohort: The participants should also have received their last dose of vedolizumab at least 6 weeks prior to study Day 1 to allow sufficient washout.
- •Participant has had signs/symptoms of moderately to severely active UC for at least 3 months prior to Screening, and the diagnosis was confirmed during the Screening Period with the following criteria: a Modified MCS of 5 to 9 (inclusive) with an MES ≥2 (confirmed by central reader).
- •Has an RHI Score of 10 or greater.
- •Has evidence of UC extending at least 15 cm from the anal verge.
- •Is an AT-naïve participant or a participant who had an inadequate response, loss of response, or intolerance to no more than 3 drugs in 2 classes of the following: a. TNF-α antagonists, including infliximab, adalimumab, or golimumab b. Interleukin (IL)-12/IL-23 antagonists, including ustekinumab c. JAK antagonists, including tofacitinib and upadacitinib d. S1P receptor agonists, including ozanimod e. Any investigational product with the same mechanism as one of those outlined above (5a through 5d) f. Integrin inhibitors, including vedolizumab (participants in the Exploratory Cohort only).
- •Meets the following wash out criteria of prior UC therapy relative to study Day 1: a. TNF-α antagonists: at least 8 weeks b. IL-12/IL-23 antagonists, including ustekinumab: at least 8 weeks c. JAK antagonists, including tofacitinib and upadacitinib: at least 2 weeks 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 Safety Follow-up Period, with the exception of tapering oral corticosteroid dose after 12 weeks of being in the trial. a. 5-Aminosalicylates (not exceeding 4.8 g per day): at least 2 weeks prior to study Day 1 b. Oral corticosteroids (not exceeding prednisone 30 mg per day, budesonide 9 mg per day, or equivalent): at least 2 weeks prior to study Day 1 c. 6-Mercaptopurine (any stable dose): at least 4 weeks prior to study Day 1 d. Azathioprine (any stable dose): at least 4 weeks prior to study Day 1 e. Methotrexate (any stable dose): for at least 4 weeks prior to study Day
- •In the opinion of the Investigator, the patient can fully participate in all aspects of this clinical study.
- •Has a body mass index (BMI) within the range of 18.0 and 40.0 kg/m2 (inclusive) at Screening.
排除标准
- •Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or CD or has clinical findings suggestive of CD.
- •Had any vaccination (including live virus vaccinations) within 3 weeks prior to study Day
- •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 predispose participants to safety risks.
- •Has a known primary or secondary immunodeficiency.
- •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.
- •Currently requires or is anticipated to require surgical intervention for UC during the study or is planning to undergo major surgery during the study period.
- •Has had a surgical procedure requiring general anesthesia within 30 days prior to Screening.
- •Has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease. For questions about whether this applies to a specific case, consult with the Medical Monitor.
- •Has positive findings on a subjective neurological screening questionnaire or progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during Screening or prior to the administration of the first dose of study drug on study Day
- •Has an active bacterial, viral or parasitic pathogenic enteric infection, including Clostridium difficile; has cytomegalovirus, hepatitis B or C virus, or human immunodeficiency virus (HIV); had an infection requiring hospitalization or intravenous antimicrobial therapy, or an opportunistic infection within 3 months prior to Screening; had any infection requiring oral antimicrobial therapy within 2 weeks prior to Screening; or has a history of more than 1 episode of herpes zoster or any episode of disseminated herpes zoster infection.
- •Has a positive diagnostic tuberculosis (TB) test at Screening.
- •Tests positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the Screening Period. Participants who test positive for SARS-CoV-2 can undergo retesting throughout the Screening Period. Testing to be performed according to site-specific testing procedures and country-specific requirements.
结局指标
主要结局
Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score.
Change from baseline to Week 12 in the Robarts Histopathology Index (RHI) Score.
次要结局
- 1. Frequencies and proportions for TEAEs, treatment-emergent serious adverse events (TESAEs), and TEAEs leading to study drug discontinuation.
- 2. Change from baseline to Week 12 in the Modified Mayo Clinic Score (MCS).
- 3. MORF-057 concentration in plasma.
- 4. Plasma PK parameters.
研究者
Morphic Clinical Development
Scientific
Morphic Therapeutic Inc.
研究点 (1)
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