Ulcerative Colitis MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
MRM Health NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged =18 years and =75 years, 2. Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of UC at least 3 months prior to Screening (a biopsy report supporting the histologic diagnosis must be available), 3. Confirmed diagnosis of mild to moderate UC at Screening as defined by an MMS =4 but =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Crohn’s Disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon, 2. Evidence of a clinically significant, active infection of the gastrointestinal tract (eg, Salmonella, Shigella, Yersinia, Campylobacter, Escherichia coli, Giardia lamblia, Vibrio, Aeromonas, Plesiomonas, Cryptosporidium, and toxigenic Clostridium difficile) or of any other organ system at Screening, unless deemed benign (eg, mild common cold), 3. Ulcerative proctitis involving only the rectum, 4. Severe UC as per modified Truelove Witts’ criteria or patients in whom colitis is most severe in the transverse colon or ascending colon, 5. Total colectomy, stoma or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon, 6. Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC, 7. History of colon carcinoma or high-grade dysplasia or absence of total endoscopy =18 months in a subject suffering from UC =8 years, 8. Previous use of any anti-TNF (eg, Infliximab), anti-integrin antibodies (eg, Entyvio) or Janus kinase inhibitors (eg, tofacitinib), 9. Use of sulfasalazine =4 weeks prior to randomization into the study, 10. Use of corticosteroids or any disease-modifying antirheumatic drug (DMARD), including thiopurines (eg, Imuran) =6 weeks prior to randomization into the study, except for a stable, low dose of oral corticosteroids (=8 mg methylprednisolone/day or equivalent) for at least 2 weeks prior to colonoscopy and remaining on the same dose up to Visit 8/EDV, 11. Conditions linked to severe immunosuppression (eg, human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy), 12. Leukopenia (total white blood cell count <3500/µL) and/or neutropenia (absolute neutrophil count <1500/µL), 13. Severe anemia (hemoglobin <10 g/dL), 14. Thrombocytopenia (peripheral blood platelet count <100 × 109/L), or any coagulation disorder with significantly increased risk of bleeding, 15. Ongoing or recent (<3 months), significant renal disease or insufficiency as manifested, eg, by medical history and/or clinical examination and/or (calculated or measured) glomerular filtration rate significantly outside normal limits for age and sex, 16. Ongoing or recent (<3 months), significant hepatic disease as manifested by medical history and/or clinical examination and/or an increase in 2.5 × the upper limit of normal for alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transpeptidase, or alkaline phosphatase, 17. Clinically significant bone marrow disease if progressive or not controlled, 18. Any protein-losing enteropathy (any cause), 19. Any systemic (autoimmune) disease if progressive or not controlled (uncomplicated and well-controlled diabetes mellitus is allowed), 20. Any granulomatous disease, 21. Increased risk of developing infectious endocarditis including: - Prosthetic cardiac valves including transcatheter-implanted prostheses and homografts, - Prosthetic material used for cardiac valve repair such as annuloplasty rings and chords, - Previous infectious endocarditis, and - Unrepaired cyanotic congenital heart disease or repaired congenital heart disease, with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or prosthetic device 22. Any history of solid organ or bone marrow transplantation, 23. Use of antibiotics (except for local use), prebiotics, or probi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the safety and tolerability of MH002 in subjects with mild to moderate ulcerative colitis (UC) ;Secondary Objective: • To evaluate the effect on disease activity of MH002 in UC • To evaluate the mechanistic effects of MH002 in UC ;Primary end point(s): • Incidence of treatment-emergent adverse events.(TEAEs).;Timepoint(s) of evaluation of this end point: Week 2, week 4, week 8, week 10, week 12, week 16 and Phone calls: Day 3, Day7(8) and week 19 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the effects on disease activity of MH002 in UC • 3-item Modified Mayo Score (MMS): sum of the Mayo symptom subscores for stool frequency and rectal bleeding and centrally assessed Mayo Endoscopic Score (MES), ie, without the Physician’s Global Assessment of disease activity, • MMS subscores, ie, stool frequency, rectal bleeding, and MES, • Rate of ‘clinical response’, defined as a decrease of =3 points on the MMS and/or a decrease of =1 on the stool frequency subscore + a decrease of =1 on the rectal bleeding subscore, • Rate of ‘clinical remission’, defined as MMS =2 and with all MMS subscores =1 and a rectal bleeding subscore of 0, • Histologic scores (Nancy Index, Geboes Score, and Robarts Histopathology Index) of colonic biopsies, and To evaluate the mechanistic effects of MH002 in UC: • Changes in stool consistency based on Bristol Stool Form Scale. • The differential expression of genes in the context of barrier integrity, including tight junction, mucin, cell proliferation, and differentiation genes (transcriptomics based on RNA-sequencing of colonic biopsies). • The differential expression of genes in the context of modulation of inflammation and immunity (transcriptomics based on RNA-sequencing of colonic biopsies). • Extent of inflammation by evaluating biomarkers in blood (including C-reactive protein, tumor necrosis factor a, and interleukins) and in feces (fecal calprotectin). • Changes in the composition of the fecal microbiome (metagenomics based on deep sequencing of fecal samples).;Timepoint(s) of evaluation of this end point: Week 8 and week 16 | — |
Countries
Belgium
Contacts
Public ContactMH002-FIH Information Desk
MRM Health NV
Outcome results
None listed