Last updated: May 9, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting
Phase
1
Condition
Crohn's Disease
Inflammatory Bowel Disease
Treatment
PRIM-DJ2727 - CAPSULES
PRIM-DJ2727 - FROZEN
Clinical Study ID
NCT05786404
HSC-MS-23-0016
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of active UC defined on clinical grounds (Partial Mayo score ≥ 3 with eachsubscore >1)
- Sexually active male and female subjects of childbearing potential must agree to usean effective method of birth control during the study.
- Female subjects of childbearing potential must have a negative urine Qualitative HumanChorionic Gonadotropin(HCG)pregnancy test at enrolment and on the Week 1, Day 1 of theTreatment prior to administration of study drug.
- Willing and able to sign an informed consent form and attend all study-related clinicvisits, assessments, and follow-up phone calls.
- Subject has an attending physician who will provide the non-FMT care.
Exclusion
Exclusion Criteria:
- Subjects with sever UC (Mayo score of >7)
- Unable to take retention enema or multiple capsules orally.
- Females who are pregnant, breastfeeding, or planning to become pregnant during thestudy.
- Receipt of systemic non-topical antibiotics within 14 days of treatment day 1.
- Positive results for active HIV, Hepatitis B, or Hepatitis C infections.
- History of recurrent Clostridium difficile infection or FMT in the past 6-months.
- History of other active gastrointestinal conditions such as irritable bowel syndrome,microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy,gastrointestinal fistulae or strictures, chronic parasitic infections, diverticulitisetc.
- Known history of bile acid diarrhea
- Compromised immune system (e.g. primary immune disorders or clinical immunosuppressiondue to a medical condition or medication e.g. taking oral prednisone >20 mg a day orprednisone-equivalent)
- History of active cancer and/or ongoing chemotherapy (superficial non-metastaticcancers and maintenance chemotherapy are permitted).
- History of use of an investigational drug within 90 days prior to the screening visit.
- History of significant uncontrolled systemic disease that in the opinion of the studyinvestigator could interfere with study participation and/or objectives.
- Life expectancy of < 1 year.
- In the opinion of investigator, subject for any reason, should be excluded from thestudy.
- Absolute neutrophil count (ANC) < 500IU/mL
Study Design
Total Participants: 20
Treatment Group(s): 2
Primary Treatment: PRIM-DJ2727 - CAPSULES
Phase: 1
Study Start date:
December 15, 2023
Estimated Completion Date:
December 15, 2027
Study Description
Connect with a study center
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesActive - Recruiting
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