NIPH Clinical Trials Search

Phase 1b/2a study of MGT-006 in patients with ulcerative colitis: A dose and preparation regimen selection trial to assess safety and microbiome engraftment

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Patients with moderately active UC
Date of first enrollment	27/05/2026
Target sample size	32
Countries of recruitment	United States,Japan
Study type	Interventional
Intervention(s)	[Investigational Product] - Product name (development code): MGT-006 - Active ingredient: Lyophilized human feces containing viable gut microbiota - Color/dosage form: White hard capsule (Capsule No. 0) [Dose and Regimen, Duration, Method of Administration] Phase 1b - MGT-006 dosage and administration: 12 capsules per day (4 capsules taken per dose, 3 times a day before meals) for 8 weeks (56 days) of repeated oral administration - Treatment Groups: Approximately 12 participants will be enrolled across the US and Japan. * No-pretreatment-antibiotics group * vancomycin group Additionally, a distinct treatment group for Japan will be set up, with a target enrollment of 6 subjects. * AFM group (amoxicillin, fosfomycin, metronidazole) Phase 2a - MGT-006 dosage and administration: Up to 12 capsules per day (subject to change depending on the Phase 1b progress) - Treatment groups: The number of groups, dose, administration method, and treatment period will be changed depending on the Phase 1b progress. Three dose groups are planned - high-dose, medium-dose, and low-dose; however, the dosage/administration and duration of treatment are subject to change depending on the Phase 1b progress. New administration regimens may also be considered.

Outcome(s)

Primary Outcome

Phase 1b -Safety and tolerability of MGT-006 (adverse events, adverse reactions) Phase 2a -Safety and tolerability of MGT-006 (adverse events, adverse reactions)

Secondary Outcome

Phase 1b - Engraftment of MGT-006-derived gut microbiota by 12 weeks after the start of MGT-006 administration *This item will be used as a major indicator for regimen selection (Gate B) when transitioning to Phase 2a of this study. - The following efficacy indicators at 8 weeks after the start of MGT-006 administration based on central imaging assessment: (1) Clinical remission rate: The percentage of subjects who achieved all of the following scores based on the modified Mayo score (MMS): * Stool frequency subscore of <= 1 and no greater than baseline * Rectal bleeding subscore of 0 points * Endoscopic subscore of <= 1 point (2) Clinical response rate: The percentage of subjects who achieved all of the following scores based on the MMS: * MMS decreased by >= 2 points and >= 30% from baseline * Rectal bleeding subscore decreased >= 1 point from baseline or became <= 1 point (3) Endoscopic improvement rate: The percentage of subjects whose endoscopic subscore is <= 1 point. Phase 2a - Engraftment of MGT-006-derived gut microbiota by 12 weeks after the start of MGT-006 administration among the dose groups - The following efficacy indicators at 8 weeks after the start of MGT-006 administration: (1) Clinical remission rates: The percentage of subjects who achieved all of the following scores based on the modified Mayo score (MMS): * Stool frequency subscore of <= 1 and no greater than baseline * Rectal bleeding subscore of 0 points * Endoscopic subscore of <= 1 point (2) Clinical response rates: The percentage of subjects who achieved all of the following scores based on the MMS: * MMS decreased by >= 2 points and >= 30% from baseline * Rectal bleeding subscore decreased >= 1 point from baseline or became <= 1 point (3) Endoscopic improvement rate: The percentage of subjects whose endoscopic subscore is <= 1 point.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 75age old
Gender	Both
Include criteria	1. Patients who understand the contents of this clinical study, sign a written informed consent form, and possess the willingness and capability to participate in all medical examinations, evaluations, and follow-ups related to the study. 2. Patients aged 18 to 75 years at the time of informed consent 3. Patients who have been diagnosed with UC through endoscopic and histological examination for at least 12 weeks at the time of final registration 4. Patients with a modified Mayo Score (according to Appendix 2) of 4 to 7 at the time of final registration - Endoscopic subscore of >= 2 - Rectal bleeding subscore of >= 1 Eligibility will be confirmed by the investigator based on the MMS and required subscores calculated per Appendix 2, using site-read endoscopy at screening.
Exclude criteria	1. Patients with any of the following medical history or complications, or those undergoing concomitant therapy, which the investigator (sub-investigator) to be serious or clinically significant: - Cardiovascular disease (e.g., heart failure, myocardial infarction, arrhythmia, ischemic heart disease) - Cerebrovascular disease, pulmonary embolism - Decompensated cirrhosis - Active infections (e.g., tuberculosis, infectious enteritis, deep mycosis) - Crohn's disease - Primary immune disease or immunocompromised state, including but not limited to uncontrolled HIV infection, hypogammaglobulinemia, history of solid organ transplantation or hematopoietic stem cell transplantation (HSCT), or other severe immunodeficiency. Immunodeficiency or immunocompromised status is defined as meeting any of the following criteria: * Total white blood cell (WBC) count < 2,000/uL * Absolute neutrophil count (ANC) < 1,000/uL * Absolute lymphocyte count (ALC) < 500/uL - Patients currently receiving calcineurin inhibitors (e.g., cyclosporine, tacrolimus) or meeting criteria for "triple immunosuppression" (defined as any three of systemic corticosteroids, immunomodulators [e.g., AZA/6-MP/MTX], and other immunosuppressants) or who have used these agents during the prohibited period(s) specified in the exclusion criterion for prior/concomitant medications. - Psychiatric disorders, drug dependence, alcohol dependence - Any other disease or condition judged by the investigator (sub-investigator) to be inappropriate 2. Patients with past or concurrent malignant tumors; however, cured basal cell carcinoma of the skin is allowed for registration. In addition, breast cancer in remission for >= 10 years without recurrence is allowed for registration, and other malignant tumors in remission for >= 5 years are allowed for registration if no therapeutic intervention is required and they are in stable condition, as determined by the investigator (sub-investigator). 3. Patients with pancolitis of > 8 years' duration or left-sided colitis of > 8 years' duration who have not undergone a surveillance flexible sigmoidoscopy or total colonoscopy (performed according to local standard of care) within 12 months prior to screening to rule out colorectal dysplasia/cancer. 4. Patients with suspected or confirmed colorectal cancer or high-grade dysplasia. 5. Patients with any of the following abnormal values in clinical laboratory tests performed within 4 weeks prior to final registration in this clinical study: - Patients with a serum creatinine level of >= 2.0 mg/dL or a BUN level of >= 25 mg/dL - Patients with a total bilirubin level of >= 3.0 mg/dL, or an AST (GOT) or ALT (GPT) level of >= 100 IU/L 6. Patients with any of the following will be excluded: - HBsAg positive (subjects may be enrolled if HBV-DNA is confirmed negative) - HCV antibody positive (subjects may be enrolled if HCV-RNA is confirmed negative) - HIV-1/2 Ag/Ab screening-positive (subjects may be enrolled if HIV 1/2 antibodies is confirmed negative) 7. Patients currently receiving inpatient treatment for UC 8. Patients suspected to have concurrent active intestinal obstruction or infectious enteritis 9. Patients with Clostridioides difficile infection (C. difficile infection) (patients in whom the presence or absence of infection is confirmed by NAAT and the result is positive) 10. Patients with a history of hypersensitivity or allergy to excipients in MGT-006 11. Patients with any of the following conditions that affect the lower gastrointestinal function: - History of colectomy or scheduled surgical treatment of the gastrointestinal tract during the study period - Difficulty swallowing capsules or tablets - Any anatomical or medical condition judged to contraindicate flexible sigmoidoscopy or total colonoscopy (e.g., shock, acute myocardial infarction, peritonitis, acute perforation, fulminant colitis, toxic megacolon) 12. Patients who have failed or been intolerant to >= 3 advanced-therapy mechanistic classes for ulcerative colitis (e.g., anti-TNF, anti-integrin, anti-IL-12/23, JAK inhibitor, S1P modulator). (1) Mechanistic class is defined by mechanism of action; multiple agents within the same class (e.g., different JAK inhibitors) are counted as one class. (2) Failed (treatment failure), as determined by the investigator, is defined as discontinuation or switch of a therapy due to inadequate response or loss of response despite an adequate trial at an approved or guideline-recommended dose and duration, as documented in the medical record. (3) Intolerant is defined as discontinuation or switch of a therapy due to an adverse event or safety concern that, in the investigator's judgment, precludes continued use, as documented in the medical record. 13. Patients with a history of treatment or use of drugs (including OTC and supplements) during the periods specified below 1) Within 8 weeks prior to final registration - Biologics for the treatment of UC - Antibiotics for the treatment of UC (topical antibiotics are permitted) - Herbal medicines (Kampo) for the treatment of UC 2) Within 4 weeks prior to final registration or 5 times the drug's elimination half-life, whichever is longer: - Topical 5-ASA preparations (enema, suppository) - Steroid preparations (excluding topical products not indicated for UC) - Cytapheresis for the treatment of UC - Oral a4 integrin inhibitor (carotegrast methyl) - Immunomodulators (cyclosporine, tacrolimus, methotrexate, azathioprine, 6-mercaptopurine, etc.) (excluding topical formulations) - S1P receptor modulators (e.g., ozanimod) - Live vaccines - Antibiotics not for the treatment of UC (topical antibiotics are permitted) 3) Within 2 weeks prior to final registration or within 5 times the drug's elimination half-life, whichever is longer - JAK inhibitors (excluding topical agents) - Antidiarrheal drugs - Drugs for treating diarrhea-predominant irritable bowel syndrome (IBS) - Bowel cleansing agents (excluding bowel preparation for flexible sigmoidoscopy or total colonoscopy for this study) - Laxatives (excluding bowel preparation for flexible sigmoidoscopy or total colonoscopy for this study) - Enemas (excluding bowel preparation for flexible sigmoidoscopy or total colonoscopy for this study) 4) Within 1 week prior to final registration - Intestinal regulators 14. Patients who have used another investigational product within 12 weeks prior to informed consent 15. Patients with serious allergies or contraindications to any drug used in this study 16. (Females only) Patients in whom the result of a pregnancy test performed within 4 weeks prior to final registration is positive (if a urine hCG test is positive, a negative serum pregnancy test result should be confirmed) 17. (Females only) Patients who are pregnant or breastfeeding, or females of childbearing potential unable to use appropriate contraceptive methods from the date of informed consent to 12 weeks post-treatment. (e.g., intrauterine device, diaphragm, partner's use of condom) 18. (Males only) Patients who are males of reproductive potential (including partners of childbearing potential) unable to use at least one effective contraceptive method from the time of informed consent until 12 weeks after the end of investigational drug administration 19. Patients judged by the investigator (sub-investigator) to be inappropriate as subjects of this study 20. (Phase 2a only) Participants who have previously received MGT-006