MGT-006 safety and dosing study for ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, early-phase study investigates repeated oral doses of MGT-006 in adults with moderately active ulcerative colitis. Phase 1b compares three pretreatment strategies (no antibiotics, vancomycin, or an AFM antibiotic combination) followed by eight weeks of MGT-006 administration and a four-week observation. Phase 2a plans to explore different doses and regimens based on Phase 1b findings, with assent to pretreatment chosen from Phase 1b. Endpoints include safety, tolerability, microbiome engraftment, and preliminary signals of clinical effect. The study is open-label and will enroll approximately 18 participants in Phase 1b and about 36 in Phase 2a across sites in Japan and the United States.

Why it matters

Who can join: the full rules

Inclusion 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 of 4 to 7 at the time of final registration

Exclusion 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
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
   * HCV antibody positive
   * HIV-1/2 Ag/Ab screening-positive
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
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)
13. Patients who have used another investigational product within 12 weeks prior to informed consent
14. Patients with serious allergies or contraindications to any drug used in this study
15. (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)
16. (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)
17. (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
18. Patients judged by the investigator (sub-investigator) to be inappropriate as subjects of this study
19. (Phase 2a only) Participants who have previously received MGT-006

Where it's running

• Fukuoka University Hospital
  Fukuoka, Fukuoka, Japan Recruiting
• Sapporo Medical University Hospital
  Sapporo, Hokkaido, Japan Recruiting
• Kawasaki Medical School Hospital
  Kurashiki, Okayama-ken, Japan Recruiting
• Kansai Medical University Hospital
  Hirakata, Osaka, Japan Recruiting
• Hamamatsu University Hospital
  Hamamatsu, Shizuoka, Japan Recruiting
• Juntendo University Hospital
  Bunkyō-Ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Metagen Therapeutics Clinical development devision
• Email: mgtx_cdu@metagentx.com
• Phone: +81-235-33-9966

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.